DIRECTORY OF SERVICES

TABLE OF CONTENTS PREFACE

Compliance Policies Licensure/Certification Requisition Form Unclear Test Orders, Test Additions, or Test Changes Turnaround Time Test Performance Characteristics

1-1 1-1 1-1 1-2 1-2 1-2



SPECIMEN PREPARATION Specimen Shipper Contents of Blood and Bone Marrow Shipper Contents of Peripheral Blood Shipper Contents of FFPE and Tissue Specimen Shipper Handling/Packing for Bone Marrow Handling/Packing for Blood Handling/Packing for FFPE and Tissue Specimen Medical Lab Box Specimen Rejection Criteria Optimal Sample Requirements COMPASS® and CHART® for Blood By Individual Sample Type COMPASS and CHART for Bone Marrow Bone Marrow Aspirate Bone Marrow Fixed Clot Bone Marrow Fixed Core Bone Marrow Fresh Core Lymph Nodes Fresh Tissue Peripheral Blood Suboptimal Samples

2-1 2-2 2-3 2-4 2-5 2-6 2-7 2-8 2-9 2-10

2-11 2-13 2-13 2-13 2-14 2-14 2-14 2-14 2-15

SMEAR/SLIDES AND CLOT PREPARATION Genoptix Medical Laboratory 2110 Rutherford Road Carlsbad, CA 92008 Phone: 760.268.6200 Fax: 760.268.6201 Client Services Phone: 800.755.1605 Fax: 888.755.1604 CLIA No: 05D1018666 CA Clinical Lab License No: CLF 11801 CAP LAP No: 7186462 Laboratory Director: Bashar Dabbas, M.D. genoptix.com

Bone Marrow Aspirate Smear Preparation Bone Marrow Aspirate Clot Preparation Blood Smear Preparation

CLIENT SERVICES Contact Information

Hours of Operation Assistance

3-1 3-2 3-3

4-1 4-1 4-1

BILLING

Hospital Billing Medicare Billing Third-Party Billing—Commercial Insurance Medicaid Billing Patient Billing Professional Courtesy Prompt-Pay Discount Charity Care Who Should be Considered for a Financial Hardship? Payment Plans

5-1 5-1 5-3 5-3 5-3 5-4 5-4 5-4 5-4 5-4

TESTING

Genoptix Medical Laboratory 2110 Rutherford Road Carlsbad, CA 92008 Phone: 760.268.6200 Fax: 760.268.6201 Client Services Phone: 800.755.1605 Fax: 888.755.1604 CLIA No: 05D1018666 CA Clinical Lab License No: CLF 11801 CAP LAP No: 7186462



Patient Privacy, Confidentiality, and HIPAA Information 6-1 CPT Codes 6-1 COMPASS Bone Marrow Evaluation 6-2 COMPASS Blood Evaluation 6-3 CHART 6-4 NexCourse 6-5 Second Opinion Consultation 6-6 Bone Marrow Morphology 6-7 Blood Morphology 6-7 Intelligent Flow Profile (Blood or Bone Marrow) — Global 6-8 Intelligent Flow Profile (Fresh Tissue) — Global 6-8 Immunophenotyping Profile (Blood or Bone Marrow) — Tech only 6-9 Immunophenotyping Profile (Fresh Tissue) — Tech only 6-9 Intelligent Flow Profile (Blood or Bone Marrow) — Interpretation only 6-10 CLL MRD Profile — Global 6-10 Myeloma MRD Profile — Global 6-11 PNH Evaluation — Global 6-11 Acute Leukemia Panel — Tech only add on 6-12 Mature B-cell Panel — Tech only add on 6-12 LGL Panel — Tech only add on 6-13 Myeloma Panel — Tech only add on 6-13 B-cell Clonality — Tech only add on 6-14 Chromosome Analysis 6-15 FISH 6-15 ALL FISH Profile 6-16 AML FISH Profile 6-16 CLL FISH Profile 6-17 CML FISH Profile 6-17 MYELOMA FISH Profile 6-18 MDS FISH Profile 6-18 MPN FISH Profile 6-19 MPN — Eosinophilia FISH Profile 6-19 B-cell NHL FISH Profile 6-20

Laboratory Director: Bashar Dabbas, M.D. genoptix.com

GENOPTIX DIRECTORY OF SERVICES



ALK Rearrangement 6-20 FGFR1 Amplification 6-21 HER 2 Amplification 6-21 MET Amplification 6-22 RET Rearrangement 6-22 ROS1 Rearrangement 6-23 ABL1 Kinase Domain Mutation 6-24 AML Molecular Profile 6-24 B-cell Clonality Assessment 6-25 BRAF Mutation Analysis 6-25 CALR Mutation Analysis 6-26 CEPBA Mutation Analysis 6-26 cKIT (D816V) Mutation Analysis 6-27 cobas BRAF V600 Mutation 6-27 EGFR Mutation Analysis 6-28 FLT3 Mutation Analysis 6-28 FLT3/NPM1 Mutation Analysis 6-29 GenoTRACE Quantitative BCR-ABL 6-29 IgVH Hypermutation Analysis 6-30 JAK2 Exon 12/13 6-30 JAK2 V617F Mutation Analysis 6-31 KRAS Mutation Analysis 6-31 MDS Molecular Profile 6-32 Melanoma Molecular Profile 6-32 MLL-PTD Mutation Analysis 6-33 MPL Mutation Analysis 6-33 MPN Molecular Profile 6-34 MSI Analysis 6-34 Myeloid Molecular Profile 6-35 NPM1 Mutation Analysis 6-35 PML/RARA Quantitative Analysis 6-36 Prosigna Breast Cancer Prognostic Gene Signature Assay 6-36 T-cell Clonality Assessment 6-37 IHC4 (ER, PR, Ki-67, HER2 with recurrence risk score) 6-38 Estrogen Receptor (ER) 6-39 Progesterone Receptor (PR) 6-40 Ki-67 6-41 HER2 6-41

LIBRARIES AND CODES

Special Stains Immunohistochemistry (IHC) Flow Markers Disease Abbreviations FISH Probes

7-1 7-1 7-3 7-5 7-6

PREFACE COMPLIANCE POLICIES Genoptix believes it has an obligation to provide clear, concise test and billing information to physicians and other authorized individuals ordering tests for the benefit of patients. The Genoptix Directory of Services has been compiled to assist in responsible test ordering and compliance with Medicare and other payors. The policies listed reflect our organization’s commitment to quality, standards, and compliance as identified by Clinical Laboratory Improvement Amendments (CLIA) and other relevant agencies, both state and federal. To comply with these guidelines, physicians should: 1. Order only those tests that are medically necessary for diagnosing or treating their patients; 2. Be certain to enter the appropriate and correct diagnosis (ICD-9-CM/ICD-10) code in both their patient files and on the test request forms; 3. When appropriate, have their patients sign and date an Advance Beneficiary Notice (ABN) if they believe that the service is likely to be denied, and ensure that patients check an option to indicate their choices regarding the potentially uncovered care described in the body of the ABN; and 4. Sign the test requisition (or patient chart indicating tests ordered). LICENSURE/CERTIFICATION Carlsbad, CA Florida No.: CLIA 05D1018666 California Clinical Lab License No.:

Maryland No.: CLF 11801

800019985 1236

New York No.: 8227 College of Pathologists Laboratory Accreditation Program (CAP LAP No.): 7186462 Pennsylvania No.: 029366 Medicare Provider No.:

05D1018666

Rhode Island No.:

LCO00643

Please refer to our Web site at www.genoptix.com for the licensure or certification or call the Genoptix Client Services Department at 800.755.1605 to obtain a copy. REQUISITION FORM The Genoptix Test Requisition Form must be completed and should be signed by an authorized individual to initiate performance of any test or service. An “authorized individual” is anyone approved under state law to order tests and/or receive test results, or their designee. The Genoptix Test Requisition Form has been designed to facilitate the ordering of only medically necessary and appropriate tests and to obtain information as required by private and federal health care providers. Because Genoptix performs specialty testing services, such as flow cytometry and FISH, an order for an analysis that contains these procedures is actually an authorization for Genoptix to perform up to the highest number of the described range of antibodies, stains, or probes on a particular specimen as deemed medically necessary by a Genoptix physician. When a Genoptix medical staff member determines that testing above the authorized range is necessary, the ordering physician will be notified and appropriate authorization requested. Those sections of the requisition that are mandatory for completion have been boxed for ease of use. This information may pertain to the ordering physician, patient, test, clinical, or billing sections. If this information is not provided, there may be a delay in test performance and billing procedures. Please contact Genoptix Client Services at 800.755.1605 with any questions regarding completion of the requisition.

PREFACE 1-1

PREFACE UNCLEAR TEST ORDERS, TEST ADDITIONS, OR TEST CHANGES To ensure that Genoptix performs only those tests requested by the ordering physician, Genoptix employs the following policies: •

When a specimen is received without an order attached or if the order is ambiguous or unclear, Genoptix will contact the physician to clarify the order before performing the test.

•

Once the ordering physician’s order has been clarified, Genoptix will perform the appropriate tests.

•

Written/electronic records of all conversations with the ordering physician or authorized member of the ordering physician’s staff will be created and maintained by Genoptix. Genoptix will also send a written authorization request to the physician, or to other authorized persons who ordered the test.

TURNAROUND TIME The Genoptix turnaround time represents the time from which the specimen arrives in our laboratory to the issuance of a final report for the requested service across standard working days. TEST PERFORMANCE CHARACTERISTICS Unless otherwise noted, all tests were developed by, and their performance characteristics determined by, Genoptix, Inc. They have not been cleared or approved by the U.S. Food and Drug Administration. Current FDA guidelines indicate such clearance is not necessary. These tests are used for clinical purposes. They should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high-complexity laboratory testing. If Genoptix changes its analytic methodology such that test results or their interpretation may be significantly different, these changes will be communicated to clients.

1-2 PREFACE

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION SPECIMEN SHIPPER Genoptix provides specimen shippers at no charge for blood and bone marrow specimens to our clients. The Genoptix Bone Marrow/Peripheral Blood and FFPE/Tissue Specimen shippers and Genoptix Peripheral Blood and GenoTRACE BCR/ABL canisters have been developed to comply with International Air Transport Association (IATA) Packing Instruction 650 and Department of Transportation (DOT) Hazardous Materials (HazMat) CFR 49, Parts 171-178, as well as all other applicable local, state, and federal laws and regulations. Specimens are shipped to Genoptix via FedEx® Clinical Paks® or via local courier with required: •

Watertight primary receptacles

•

Watertight secondary receptacles

•

Absorbent material

•

Sturdy outer packaging

FedEx® and FedEx Clinical Pak® are registered marks of Federal Express.

SPECIMEN PREPARATION 2-1

SPECIMEN PREPARATION CONTENTS OF BLOOD AND BONE MARROW SHIPPER

1) Bone marrow and peripheral blood shipper

2) Two green-top and two purple-top tubes

3) Two plastic slide cassettes containing glass slides

4) Two vials containing B-Plus fixative in a sealed specimen bag

5) One cold pack

6) One requisition form

7) One biohazard bag

8) One FedEx Clinical Pak

9) One FedEx receipt

2-2 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION CONTENTS OF PERIPHERAL BLOOD AND CANISTER SHIPPER

1) Peripheral blood canister shipper

2) Two green-top and one purple-top tube

3) One plastic slide cassette containing glass slides

4) One absorbent sleeve

5) One requisition form

6) One biohazard bag

7) One FedEx Clinical Pak

8) One FedEx receipt

SPECIMEN PREPARATION 2-3

SPECIMEN PREPARATION CONTENTS OF FFPE AND TISSUE SPECIMEN SHIPPER

1) FFPE and Tissue Specimen Shipper

2) One purple-top tube

3) Three biohazard bags

4) Two plastic slide cassettes containing glass slides

5) One requisition form

6) One FedEx Clinical Pak

7) Only if requested, two vials of transport media in a sealed specimen bag

8) One FedEx receipt

2-4 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION CONTENTS OF GENOTRACE BCR-ABL CANNISTER SHIPPER

1) BCR-ABL blood canister shipper

2) One purple-top tube

3) One absorbent sleeve

4) One requisition form

5) One biohazard bag

6) One FedEx Clinical Pak

7) One FedEx receipt

SPECIMEN PREPARATION 2-4a

2-4b SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION HANDLING/PACKING FOR BONE MARROW • Gently invert all tubes 8 times to avoid clots. • Store specimens at room temperature until transport. • Please submit all specimens within 24 hours of collection for optimal results. •

Remove cold pack and place in refrigerator for as long as possible, or at least 2 hours prior to drawing specimens from patient.

• Place labeled tubes, one on top of the other, in designated foam holder. Insert plastic slide cassettes into foam. Place B-Plus vials into biohazard bag, roll, and place in foam. (It is important that the fixative material be separated from smears by containment in a sealed bag. Fumes from the fixative can affect subsequent slide staining.) NOTE: Specimen tubes must be labeled with two unique patient identifiers.

1)

Place labeled tubes, one on top 2) Place refrigerated cold pack on of the other, in designated foam top of specimens. holder. Insert plastic slide cassettes into foam. Place B-Plus vials into biohazard bag, roll, and place in foam.

3)

Return completed requisition 4) Place shipper into provided form and close shipper. Include biohazard bag. recent CBC results and clinical history, if available. NOTE: Please ensure that there is no patient information on the outside of the box.

• Place refrigerated cold pack on top of specimen. •

Place completed requisition form inside shipper. NOTE: Please ensure that there is no patient information on the outside of the shipper.

• Place shipper into provided protective large biohazard bag. • Place bagged shipper into provided FedEx Clinical Pak. • Call Genoptix Client Services at 800.755.1605 to schedule pick-up. Proper packaging of a biological specimen helps to ensure optimum viability of a patient’s specimen, and complies with IATA (International Air Transport Association) regulations. For Federal Express shipment: • Place secured box inside FedEx Clinical Pak and seal according to instructions on the Clinical Pak. Place only one (1) shipper in each Pak. • Call Genoptix to schedule pick-up at 800.755.1605. For questions regarding specimen preparation or shipping, call Genoptix Client Services at 800.755.1605.

5) Place bagged shipper into provided FedEx Clinical Pak and seal. 6) Call Genoptix Client Services at 800.755.1605 to schedule pick-up.

SPECIMEN PREPARATION 2-5

SPECIMEN PREPARATION HANDLING/PACKING FOR BLOOD • Gently invert all tubes 8 times to avoid clots. • Store specimens at room temperature until transport. • Please submit all specimens within 24 hours of collection for optimal results. • Place labeled tubes in slotted absorbent sleeve. Roll up tubes in absorbent sleeve, place in biohazard bag and seal shut. NOTE: Specimen tubes must be labeled with two unique patient identifiers. • Fold and place completed test requisition form inside back slit on biohazard bag. NOTE: Please ensure that there is no patient information on the outside of the canister.

1)

Contents of canister: 1 purple- 2) Place tubes in slotted absorbent top tube, 2 green-top tubes, sleeve. 1 absorbent sleeve, 1 biohazard bag, 2 tube labels (not shown), 1 slide box with 5 slides, 1 FedEx® Clinical Pak® with billable stamp attached.

• Place rolled up biohazard bag and slides into canister and screw lid on securely. • Place canister into provided FedEx Clinical Pak. • Call Genoptix Client Services at 800.755.1605 to schedule pick-up. Proper packaging of a biological specimen helps to ensure optimum viability of a patient’s specimen, and complies with IATA (International Air Transport Association) regulations.

3) Roll up tubes in absorbent 4) Roll up biohazard bag. sleeve, place in biohazard bag and seal shut. Fold Test Requisition and other patient documentation, and place in slit in back of biohazard bag.

For Federal Express shipment: • Place secured box inside FedEx Clinical Pak and seal according to instructions on the Clinical Pak. Place only one (1) shipper in each Pak. • Call Genoptix to schedule pick-up at 800.755.1605. For questions regarding specimen preparation or shipping, call Genoptix Client Services at 800.755.1605.

5) Place rolled up biohazard bag 6) Place canister in FedEx Clinical and slides into canister and Pak provided and seal. screw lid on securely. NOTE: Additional canisters (limit 6) can be placed in one Clinical Pak. 7) Call Genoptix Client Services at 800.755.1605 to schedule specimen pickup. Provide the Client Service Agent with the tracking number(s) of the specimen(s) being sent.

2-6 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION HANDLING/PACKING FOR FFPE AND TISSUE SPECIMEN • Store specimens at room temperature until transport. •

Place labeled slide cassette and/or paraffin-embedded tumor tissue block and purple-top (EDTA) tube into foam slot.

• Place refrigerated cold pack on top of specimens. • Place completed requisition form inside shipper. NOTE: Please ensure that there is no patient information on the outside of the shipper. • Place shipper into provided large biohazard bag.

1)

Place labeled slide cassette and/or 2) Place refrigerated cold pack on paraffin-embedded tumor tissue top of specimens, block and purple-top (EDTA) tube into foam slot.

• Place bagged shipper into provided FedEx Clinical Pak. • Call Genoptix Client Services at 800.755.1605 to schedule pick-up. Proper packaging of a biological specimen helps to ensure optimum viability of a patient’s specimen, and complies with IATA (International Air Transport Association) regulations. For Federal Express Shipment: •

Place secured box inside FedEx Clinical Pak and seal according to instructions on the Clinical Pak. Place only one (1) shipper in each Pak.

3) Place completed requisition form 4) Place shipper into provided inside shipper. Samples must be biohazard bag. sent within 24 hours of draw. NOTE: Please ensure that there is no patient information on the outside of the box.

• Call Genoptix to schedule pick-up at 800.755.1605. For questions regarding specimen preparation or shipping, call Genoptix Client Services at 800.755.1605.

5) Place bagged shipper into provided FedEx Clinical Pak. 6) Call Genoptix Client Services at 800.755.1605 to schedule pick-up.

SPECIMEN PREPARATION 2-7

SPECIMEN PREPARATION MEDICAL LAB BOX THE GENOPTIX MEDICAL LAB BOX PROVIDES YOU WITH A SAFE PICK-UP OPTION FOR LATE DRAWS. BENEFITS OF USING A LAB BOX • Holds 2–3 FedEx Clinical Paks. A larger model is also available that holds 3–4 Clinical Paks. • The lab box is a safe and secure place to store the specimen and allow courier access. Lab boxes have a combination lock, with the combination provided to the courier for retrieval. • When a late pick-up is necessary, lab boxes can be placed outside the office or secured under the door. • Genoptix can safely retrieve your specimen even if our courier is delayed en route due to traffic, or if a pick-up is scheduled with less than a 90-minute window prior to the office closing. • To have your late-drawn specimen picked up after office hours, your staff can make arrangements with Client Services at 800.755.1605 and leave the office. • Please contact your Diagnostic Sales Specialist or Client Services Representative to have a lab box sent to your office. A secure, combination-locked lab box

CALL 1.800.755.1605 AND CHOOSE OPTION 2 TO SPEAK WITH A CLIENT SERVICES REPRESENTATIVE.

2-8 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION SPECIMEN REJECTION CRITERIA A specimen may be rejected for any of the following reasons: •

Improperly sealed specimen — specimen has leaked from the tube during shipping or the tube was not inadequately filled (e.g., < 2 mL in a 6 mL tube) such that the test could not be completed.

•

The Genoptix Test Requisition is not received with the specimen, and the specimen’s origin cannot be determined. Specimens will also be rejected in those instances where a client can be identified but has not provided a verbal or written request.

•

The specimen is mislabeled, or the information on the label does not match that provided on the Genoptix Test Requisition. Genoptix will attempt to resolve any discrepancies in labeling information through client contact, but in the event the client cannot be reached or does not respond within 3 days, the specimen may be rejected.

•

The specimen is collected in a tube containing an anticoagulant or preservative other than that specified (e.g., lithium heparin).

• The specimen is received at Genoptix more than 48 hours after collection for bone marrow aspirate, or 72 hours after collection for peripheral blood. • There aren’t enough cells present in the specimen to perform a complete test. • There aren’t enough cells present in the specimen to perform even an abbreviated test (consisting of a condensed list of markers or stains as determined by the medical staff in consultation with the client). •

There is 1.0 cm (length) in B-Plus vial

*Although bedside smears are preferred, Genoptix will make bone marrow smears when adequate material is provided: •

Light green-top (lithium heparin) tubes ARE NOT acceptable.

•

Clotted, hemolyzed, or frozen samples ARE NOT acceptable.

•

Clearly label each tube and slide with patient name and other unique numeric identifier and specimen type.

•

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

• Store at room temperature. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. Refrigerate only. The samples for a complete bone marrow evaluation originate from multiple sources: •

Aspirate (the liquid from the marrow)

•

Core (solid material obtained from the needle’s penetration of the bone marrow)

•

Clot (aspirate allowed to congeal in the needle syringe)

•

Peripheral Blood

SPECIMEN PREPARATION 2-11

SPECIMEN PREPARATION OPTIMAL SAMPLE REQUIREMENTS COMPASS AND CHART DRAWING BONE MARROW SAMPLES FOR COMPASS AND CHART If possible, marrow aspirate should be collected in two syringes, one for each pull: 1. First pull/syringe of aspirate: 2-3 cc (2-3 mL). a.  Bone Marrow Aspirate Smears: (See page 3-1, Smear/Slides and Clot Preparation section for bone marrow smear). Bone marrow smears prepared immediately after collection have been shown to provide significantly better morphology than smears made at a later time or from an anticoagulated specimen. b. Bone Marrow Fixed Clot: Once formed, clot (>1.0 cm in length) should be placed in a B-Plus vial. 2. Second pull/syringe of aspirate: 4-5 cc (4-5 mL). a.  Bone Marrow Aspirate: Place approx. 2 cc (2 mL) of the aspirate into a green-top (sodium heparin) tube. This material will be used for flow cytometry. b.  Bone Marrow Aspirate: Place approx. 2 cc (2 mL) of the aspirate into a second green-top (sodium heparin) tube. This material will be used for other necessary tests (i.e., cytogenetics/FISH). c. Bone Marrow Aspirate: Any remaining aspirate should be put into a purple-top (EDTA) tube and submitted for molecular tests or other analysis. d.  Bone Marrow Fixed Core Sample: Entire core (>1.0 cm in length) should be placed in a B-Plus vial.

First pull of marrow aspirate 2-3 cc (2-3 mL)

Marrow aspirate smears

Clot in B-Plus

Second pull of marrow aspirate 4-5 cc (4-5 mL)

2 cc (2 mL) in green-top tube Used for flow cytometry

2 cc (2 mL) in green-top tube Used for cytogenetics/FISH

Remainder in purple-top tube Used for molecular testing

Core in B-Plus

2-12 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION OPTIMAL SAMPLE REQUIREMENTS BY INDIVIDUAL SAMPLE TYPE BONE MARROW ASPIRATE Flow Cytometry: 2-3 mL in green-top (sodium heparin) tube. Cytogenetics/FISH: 2-3 mL in green-top (sodium heparin) tube. Molecular Tests: 2-3 mL in purple-top (EDTA) tube. •

Light green-top (lithium heparin) tubes ARE NOT acceptable.

•

Clotted, hemolyzed, or frozen samples ARE NOT acceptable.

•

First pull marrow is preferred. Please label tube as “FIRST PULL.”

• Samples stored beyond 48 hours ARE NOT acceptable for molecular tests. Specimens should be sent within 24 hours of draw. • Clearly label each tube with patient name and other unique numeric identifier and specimen type. NOTE: Specimen tubes must be labeled with two unique patient identifiers. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

• Store at room temperature. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. Refrigerate only. BONE MARROW FIXED CLOT Immunohistochemistry: >1.0 cm (length) in B-Plus vial. Bone Marrow Morphology: >1.0 cm (length) in B-Plus vial AND four (4) to eight (8) bedside bone marrow aspirate smears AND two (2) bedside peripheral blood smears OR 1 mL aspirate and blood each in purpletop (EDTA) tubes: • Clearly label the vial and slides with patient name and other unique numeric identifier and specimen type. NOTE: Specimen tubes must be labeled with two unique patient identifiers. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

• Store at room temperature. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. Refrigerate only. BONE MARROW FIXED CORE Immunohistochemistry: >1.0 cm (length) in B-Plus vial. Bone Marrow Morphology: >1.0 cm (length) in B-Plus vial AND four (4) to eight (8) bedside bone marrow aspirate smears AND two (2) bedside peripheral blood smears OR 1 mL aspirate and blood each in purpletop (EDTA) tubes: • Clearly label the vial and slides with patient name and other unique numeric identifier and specimen type. NOTE: Specimen tubes must be labeled with two unique patient identifiers. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

• Store at room temperature. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. Refrigerate only.

SPECIMEN PREPARATION 2-13

SPECIMEN PREPARATION OPTIMAL SAMPLE REQUIREMENTS BY INDIVIDUAL SAMPLE TYPE BONE MARROW FRESH CORE (In the event of a dry tap, see page 2–16.) Flow Cytometry: >1.0 cm (length) in RPMI. • Clearly label the vial with patient name and an other unique numeric identifier and specimen type. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

•

DO NOT use RPMI if it appears cloudy, yellow, or beyond the expiration date.

•  Store refrigerated. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. LYMPH NODES Flow Cytometry: Place in RPMI. • Clearly label the vial with patient name and an other unique numeric identifier and specimen type. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

•

DO NOT use RPMI if it appears cloudy, yellow, or beyond the expiration date.

•  Store refrigerated. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. FRESH TISSUE Flow Cytometry: Place in RPMI. • Clearly label the vial with patient name and an other unique numeric identifier and specimen type. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

•  DO NOT use RPMI if it appears cloudy, yellow, or beyond the expiration date. •  Store refrigerated. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. PERIPHERAL BLOOD Morphology: 1-2 mL in purple-top (EDTA) tube AND two (2) fresh smears. Flow Cytometry: 5-6 mL in green-top (sodium heparin) tube. Cytogenetics/FISH: 5-6 mL in green-top (sodium heparin) tube. Molecular Testing: 2-3 mL in purple-top (EDTA) tube. If WBC < 5000: 4-5 mL in two purple-top (EDTA) tubes. • Light green-top (lithium heparin) tubes ARE NOT acceptable. • Clotted, hemolyzed, or frozen samples ARE NOT acceptable. • Samples stored beyond 48 hours ARE NOT acceptable for molecular tests. Specimens should be sent within 24 hours of draw. • Clearly label each tube with patient name and an other unique numeric identifier and specimen type. •

Include when available: 1) CBC, 2) clinical history or note, and 3) prior test results.

• Store at room temperature. DO NOT freeze specimens. Ship with cold pack. DO NOT freeze cold pack. Refrigerate only.

2-14 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SPECIMEN PREPARATION SUBOPTIMAL SAMPLES DEFINITION: “Dry Tap,” or Suboptimal Bone Marrow Samples When a physician performs a bone marrow biopsy or “tap”, there can be very little or no aspirate obtained or few, or no marrow particles in the aspirate. Dry taps produce too few bone marrow cells to allow a diagnosis. CAUSE: Dry taps can result when the marrow is aplastic (lacking in cell production), hypocellular (too few hematopoietic cells versus fat cells), tightly packed with neoplastic cells, or is fibrotic (containing excessive fibrous tissue). This may also happen when the bone marrow needle is improperly placed in the marrow cavity. FREQUENCY: Patients with hairy cell leukemia (HCL), myelofibrosis, aplastic anemia, and metastatic cancer are more apt to produce a dry tap. MEDIA: If an adequate core biopsy can be obtained, a great deal of information is derived through immunohistochemical staining of the core. However, optimal cytogenetic and flow analyses require an unfixed specimen, which should be shipped in RPMI media. If there are circulating malignant cells, this may also be obtained from a tube of peripheral blood drawn in heparin. RPMI

Dry taps should ideally be sent to Genoptix in RPMI media.



RPMI can be ordered from Client Services and will be shipped to the client with cold packs, as RPMI must be refrigerated.



RPMI has a 6-month shelf-life, if refrigerated, and all tubes are sent with an expiration date identified. RPMI should not be used if it is beyond the expiration date, cloudy, or yellow. RPMI should be pinkish/ orange in color.

SPECIMEN REQUIREMENTS: •

1 core in B-Plus

•

1 core in RPMI (no saline)

•

2-3 touch preps

•

1 purple top (EDTA) of peripheral blood

See instructions for handling/packaging blood and bone marrow starting on page 2-5.

SPECIMEN PREPARATION 2-15

SPECIMEN PREPARATION SUBOPTIMAL SAMPLES RPMI Bone Marrow Packaging Requirements 1. Remove RPMI tube and cold pack from refrigerator. Remove one B-Plus vial from Genoptix shipper. a. RPMI should not be used if it is beyond the expiration date, cloudy, or yellow. It should be pinkish/ orange in color.

b. RPMI has a refrigerated shelf life of 6 months.

2. Perform bone marrow tap. If possible, take 2 core samples. 3. Prepare 2–3 touch preps from biopsy material. Place slides in plastic cassettes provided in Genoptix shipper. Slides should be completely air-dried before placing in cassette(s). 4. Place one core in RPMI. Place other core in B-Plus. Ensure that caps are tightly closed on each container. 5. If only one core sample is available, predetermine if flow cytometry/cytogenetics or histopathology is more important. Complete the Genoptix Test Requisition accordingly.

•

Flow cytometry/cytogenetics = RPMI



•

Histopathology = B-Plus

6. Place B-Plus vial in small biohazard bag. 7. Place RPMI tube in separate biohazard bag. 8. Prepare 4–8 peripheral blood bedside smears and place in plastic cassettes provided in Genoptix shipper. Slides should be completely air-dried before placing in cassette(s). 9. Place bags and plastic slide cassettes into Genoptix shipper. Place refrigerated cold pack on top of foam. DO NOT allow cold pack to come into contact with RPMI tube or B-Plus vial. 10. Ship refrigerated to Genoptix. 11. Contact Genoptix Client Services at 800.755.1605 with any questions.

2-16 SPECIMEN PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SMEAR/SLIDES AND CLOT PREPARATION NOTE: Blood or bone marrow aspirate smears prepared immediately after collection and completely air-dried have been shown to provide the most meaningful results. Cell distortion can occur when smears are improperly prepared or stored in anticoagulant for an extended amount of time. These instructions have been provided as general guidelines for smear preparation.

BONE MARROW ASPIRATE SMEAR PREPARATION Required Items: •

Two syringes

•

6-12 clean glass slides

•

A pair of gloves

•

Bone marrow biopsy/aspiration tray (from Genoptix or other vendor)

•

Genoptix shipper

Slide Preparation: 1. Start with one syringe. For best results, an initial quick pull obtaining 2-3 mL of bone marrow aspirate is best. Marrow aspirate should contain spicules (small pieces of bone) whose presence can be confirmed visually (Figure 4, page 3–2). 2. Lay out six to eight clean slides.

Figure 1

3. Use the same syringe to deliver a small amount of the bone marrow aspirate on each slide, at the end closest to the frosted edge (Figure 1). 4. Pick up a clean slide and gently bring it down flat on top of the slide containing the small drop of bone marrow aspirate. Allow the liquid to spread out between the two slides (Figure 2).

Figure 2

SMEAR PREPARATION 3-1

SMEAR/SLIDES AND CLOT PREPARATION BONE MARROW ASPIRATE SMEAR PREPARATION 5. With a steady motion and without pressure (to avoid crushing the spicules), pull the top slide across the lower slide, spreading the specimen along the length of that slide (Figure 3).

a. When properly prepared, the specimen should be spread evenly along the bottom slide in an elongated, oval shape, and spicules should be visible (Figure 4).



b. The smear should be of equal thickness across the length of the slide. A smear that is too thick cannot be read.

Figure 3

Figure 4

6. Please label all slides with the patient’s name and other unique identifier and specimen type (BM for bone marrow aspirate). 7. Allow slides to air-dry completely. NOTE: Wet smears may stick to each other and the slide cassette, making the slides unusable. 8. Place the air-dried slides into the plastic slide cassette.

BONE MARROW ASPIRATE CLOT PREPARATION 1. Upon completion of the spotting for the slides, retain a small amount (about 1-2 mL) of aspirate in the syringe. 2. Allow this to clot for 10–20 minutes. 3. When this material has clotted, eject it through the open end of the syringe and into one of the B-Plus vials.

3-2 SMEAR PREPARATION

GENOPTIX DIRECTORY OF SERVICES

SMEAR/SLIDES AND CLOT PREPARATION BLOOD SMEAR PREPARATION Required Items: •

3-4 clean glass slides

•

A pair of gloves

•

Blood draw kit

Preparation: 1. Smears should be prepared immediately after the patient draw from a purple-top (EDTA) tube or from the syringe in case of a syringe draw. 2. Upon completion of the draw, deliver one (1) small drop of blood to each slide on the end closest to the frosted edge (Figure 5).

Figure 5

3. After placing the blood on the slide, place the slide on a flat surface. 4. With one hand, hold the edges of the slide between thumb and forefinger on the flat surface. 5. Pick up a second slide with the free hand. This slide will be used to spread the blood across the resting slide surface. Be sure not to extend the blood to the full length of the slide or the slide will not be stained properly; if this happens, the slide will be unusable. 6. Position the spreader slide at a 30- to 40-degree angle with the other slide. This angle should be maintained throughout the procedure and when properly established, the raised edge of the spreader slide will be about one (1) inch above the resting slide surface (Figure 6).

Figure 6

SMEAR PREPARATION 3-3

SMEAR/SLIDES AND CLOT PREPARATION BLOOD SMEAR PREPARATION 7. Draw the spreader slide toward the drop of blood, and allow the slide to make contact with the blood. The drop of blood should fan to the edges of the spreader slide. DO NOT allow the blood to move ahead of the spreader slide, as this may distort the cells (Figure 7 ).

Figure 7

8. Quickly move the spreader slide smoothly and rapidly over the length of the resting slide while maintaining the 30- to 40-degree angle and firm pressure.

a. When properly prepared, the blood smear should make a gradual transition from thick to thin.

b. It is acceptable for only half of the slide to be covered by the thin area with the maintenance of a gradual transition (due to the staining process). NOTE: The feathered edge is the most important part of the smear (Figure 8).

Figure 8

9. Please label all slides with the patient’s name and other unique identifier and specimen type (PB for peripheral blood). 10. Allow the slide to air-dry completely (slides should dry for at least 20 minutes and look visibly dry before being placed into the cassette).

NOTE: Wet smears may stick to each other and the slide cassette, making the slides unusable.

11. Place the air-dried slides into the plastic slide cassette.

3-4 SMEAR PREPARATION

GENOPTIX DIRECTORY OF SERVICES

CLIENT SERVICES Genoptix is committed to providing the highest possible standard in customer service and ensuring that you and your patients receive timely and accurate information. We will always strive to meet your needs. CONTACT INFORMATION Phone: 800.755.1605 Fax: 888.755.1604 HOURS OF OPERATION A Genoptix Client Services Representative is available: Monday – Friday, 5:00 a.m. – 7:00 p.m. (PT) Saturday, 7:00 a.m. – 3:30 p.m. (PT) If you are calling during off-hours, select Option 7 to be connected to an after-hours Client Service Representative. For specimen pick-up, call 800.755.1605. CLIENT SERVICES ASSISTANCE Genoptix Client Services Representatives are trained to assist you in several of the following areas: •

Consultation with a Genoptix hematopathologist

•

Specimen requirements and handling

•

Requisition completion

•

Report status/report distribution

•

Client supplies

•

Technical information

•

eCOMPASS® utilization

Client Services can also direct inquiries to our medical staff and assure that you have professional consultation services whenever needed. Physicians with an urgent patient matter: call 800.755.1605.

eCOMPASS3.0® is a U.S. registered mark of Genoptix, Inc.

CLIENT SERVICES 4-1

BILLING HOSPITAL BILLING CLIENT BILL — DIRECT BILL To be billed directly for performed laboratory services, hospital clients should mark the “My Account (Hospital/Client)” box on the test requisition and refrain from attaching any insurance information. Payments should be sent to: Genoptix Medical Laboratory PO Box 644828 Pittsburgh, PA 15264-4828 Invoices may also be reviewed and be paid online through our secure, web portal. Please contact your local representative if you would like to set up online invoicing. SPECIAL CONSIDERATION FOR HOSPITAL MEDICARE BILLING Medicare has a number of unique billing rules, many of which require that we invoice the hospital directly. Specifically, for hospital inpatient and outpatients, Genoptix must invoice the Hospital for all technical component and clinical laboratory testing when such testing is ordered less than 14 days from the date of discharge. If services are ordered 14 days or later from the date of discharge, Genoptix is permitted to bill the Medicare program directly. In the event that a hospital orders testing for specimens that are not acquired while the patient is hospitalized (e.g., lab outreach), Genoptix is permitted to bill Medicare directly. Please check the “Non-hospital Patient” box in the Medicare billing section of the test requisition, and provide the requested insurance information or attach a photocopy of the Medicare card, or provide a photocopy of the hospital face sheet that includes insurance information. Genoptix testing services that are specifically requested or statutorily required to be billed directly to our hospital clients will be billed monthly by an itemized invoice that includes the date, patient’s name, specimen number, test(s) performed, and the test fees. Please note that unless other arrangements are made, these invoices are payable upon receipt. If you have any questions pertaining to your account, please notify us immediately so that we may resolve them in a timely manner. Any adjustments will appear on the following month’s invoice. MEDICARE BILLING COVERAGE AND MEDICAL NECESSITY Medicare Part B covers medically necessary clinical diagnostic laboratory services that are ordered by a patient’s doctor or practitioner. Laboratory tests include certain blood tests, tests on tissue specimens and some screening tests. These tests must be provided by a laboratory that meets Medicare requirements. When ordering any test for which you’ll seek reimbursement by any of the federal health programs, consider carefully the medical necessity and cost of these tests. WHEN A PATIENT IS A MEDICARE BENEFICIARY As a participating provider with Medicare, Genoptix accepts assignment, which means that the approved charge, determined by the MAC, shall be the full charge for the service covered under Part B. The participant (Genoptix) will not collect from the Medicare beneficiary or other person or organization for covered services more than the applicable deductible and coinsurance. The vast majority of the services we provide are billed under the Medicare Physician Fee Schedule (MPFS), in which case Medicare will pay 80% of the allowable amount, leaving the remaining 20% coinsurance amount to be paid by the patient. Additionally, each year, the Medicare beneficiary must meet a deductible amount ($147 for 2015) prior and incremental to the co-insurance amount. For services we provide under the Clinical Laboratory Fee Schedule (CLFS), Medicare will typically pay 100% of its allowable charges, and no coinsurance or deductible amounts are applicable. For Medicare patients who have supplemental or “Medi-gap” insurance, Genoptix will bill the supplemental insurance payer for the appropriate deductible or coinsurance amounts.

5-1 BILLING

GENOPTIX DIRECTORY OF SERVICES

BILLING ADVANCE BENEFICIARY NOTICE If reimbursement is denied due to lack of medical necessity documentation, Medicare rules prohibit the laboratory or health care provider from billing the patient unless an Advance Beneficiary Notice (ABN) has been signed and dated by the patient prior to the date of service. As applicable, an ABN must be completed each time services are ordered. Blanket ABNs are not acceptable to the Medicare program. The Centers for Medicare and Medicaid Services (CMS) has established a standardized ABN format that must be used. The CMS ABN ensures that the patient understands he or she may be responsible for payment if the test is considered to be medically unnecessary by Medicare. The ABN identifies the laboratory test(s) subject to medical necessity coverage guidelines and gives the reason(s) the test(s) is likely to be denied. The test information on the ABN may be customized to the specific local Medicare carrier policies, identifying it as being subject to a National Coverage Determination (NCD) or Local Coverage Determination (LCD). NATIONAL COVERAGE DETERMINATIONS Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). NCDs are made through an evidence-based process, with opportunities for public participation. In some cases, CMS’ own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on an LCD. NCDs are consistent for all local Medicare carriers and have established a list of diagnosis codes that are acceptable for each of these procedures. NCDs override and/or replace any local policies established by the local Medicare carriers for these same procedures. If a physician does not submit a supportive diagnosis code for a procedure subject to NCDs, Genoptix may contact that physician’s office to ask for a copy of a properly executed ABN or to determine whether there are any other applicable diagnoses for that date of service. In a post-payment audit, the requesting physician may still be asked to provide documentation that a procedure(s) was medically necessary for a particular patient’s condition. This is why it is critical for physicians to record appropriate documentation detailing the medical necessity in a patient’s medical chart. LOCAL COVERAGE DETERMINATIONS Local Medical Administrative Contractors (MAC) have the authority to establish policies to limit coverage for laboratory procedures based on the carrier’s view of the medical necessity for that procedure. These local policies, known as Local Coverage Determinations (LCDs), may not in any way conflict with the National Coverage Determinations. The carrier with jurisdiction over the lab that is responsible for performing the service determines the coverage procedures for ordering physicians. Again, these procedures and codes vary from carrier to carrier. If a physician does not submit a supportive diagnosis code for a limited coverage procedure, Genoptix will contact that physician’s office to ask for a copy of a properly executed ABN or to determine whether there are any other applicable diagnoses for that date of service. In a post payment audit, the requesting physician may still be asked to provide documentation that a procedure(s) was medically necessary for a particular patient’s condition. This is why it is critical for physicians to record appropriate documentation in a patient’s medical chart. Finally, in some instances, even if a physician thinks a particular test is appropriate for the indicated diagnosis listed on the test request form, the Medicare carrier with jurisdiction over our laboratory may not accept that code as supporting the medical necessity of the test. Genoptix is subject to both Medicare National Coverage Determinations (NCDs) and the Local Coverage Determinations (LCDs) of the Medicare Part B Medicare Administrative Contractor (MAC) for California, Noridian Healthcare Solutions. To obtain a listing of active or draft LCDs, please go to the Noridian Medicare website at www.noridianmedicare.com/web/jeb.

BILLING 5-2

BILLING THIRD-PARTY BILLING—COMMERCIAL INSURANCE Genoptix will bill third-party carriers directly if complete and accurate information is provided on the test requisition form. We must have the “Billing Information” section of the test requisition form completed, or a copy of the patient’s insurance card (front and back) or client’s insurance face sheet attached to the test requisition form. Subject to applicable federal, state, and local laws, Genoptix will accept plan-allowable reimbursement amounts from third-party carriers, irrespective of contracting status. As required by law, Genoptix must bill patients for any applicable co-insurance and deductibles. This may include the full statement balances for denied claims or claims submitted to carriers who have not responded to a Genoptix request for payment. For additional information, please contact your local sales representative or the Genoptix Billing Department at 800.755.1605 or by email at [email protected]. MEDICAID BILLING Genoptix is currently contracted with two state Medicaid programs at this time, Georgia and Illinois. Please contact the Genoptix Billing Department at 800.755.1605 for more information. PATIENT BILLING As circumstances dictate, Genoptix will bill patients directly for services we have provided. If you are requesting such a billing arrangement, please mark the Bill to: “Patient” box on the test requisition. Money order, check, or credit card is an acceptable form of payment. All funds must be in U.S. dollars. The following must be clearly identified on each Genoptix test requisition form: Patient Name Street Address Zip Code Telephone Number Failure to provide this information may result in test delays.

5-3 BILLING

GENOPTIX DIRECTORY OF SERVICES

BILLING PROFESSIONAL COURTESY The offering of a professional courtesy (i.e., reducing or waiving charges to physicians or other individuals that order services from us), is a practice that the federal government and the OIG (Office of the Inspector General) believe may constitute a financial benefit given to those individuals for the purpose of inducing referrals. Such inducements are illegal under the federal anti-kickback statute. Consequently, Genoptix will not extend professional courtesies. PROMPT-PAY DISCOUNT Patients are entitled to a prompt-pay discount if payment is received within 45 days from receipt of their first bill. CHARITY CARE We are committed to treating all patients equitably, with dignity, respect and compassion. We provide our laboratory services in anticipation of payment by the patient and/or payer. We will, however, consider reducing or waiving patient charges only after determining in good faith that a patient is in financial need (See types of indigence considered below). Recognizing that our physician client is uniquely familiar with their patient’s financial situation, we routinely rely on the referring physicians’ attestation of the patient’s level of hardship when determining the amount of discount we will give to the patient for the services we provide. More specifically, Genoptix will match the level of charity care provided by the referring physician. In order to do so, we require that you consult your patient regarding their need for financial assistance, complete a Patient Financial Hardship Form, and submit it along with the test requisition or separately to our client services or billing department. Forms can be obtained from your sales representative, by calling the Genoptix Billing Department at 800.755.1605, or by sending a request by email to: [email protected]. Upon receipt of the Patient Financial Hardship Form, we will determine eligibility for financial aid and assist patients to qualify for assistance. We utilize payment procedures for uninsured or medically underinsured patients, which take into consideration other payment arrangements with insurance companies, managed care networks and government-sponsored programs. WHO SHOULD BE CONSIDERED FOR A FINANCIAL HARDSHIP? FINANCIALLY INDIGENT PATIENT Patients who are uninsured or underinsured, with annual income at or below 200% of the federal poverty guidelines may qualify for no obligation or a discounted obligation for the services provided. MEDICALLY INDIGENT PATIENT Patients whose gross annual income exceeds 200% of the Federal Poverty index, and who have documented medical bills with Genoptix and/or other health care providers that total more than 10% of their gross annual income, will be eligible for a discounted obligation and/or payment terms for the services provided. PAYMENT PLANS We also offer patients who qualify for financial assistance a reasonable variety of payment options and/ or terms for payment, including partial payment as permitted by law. Qualified patients are eligible for payment plans regardless of insurance status. Patients should call the Genoptix Billing Department at 800.755.1605 upon receipt of his or her first bill if they are interested in requesting a payment plan for their outstanding liability. There is typically no fee or interest charge for this program.

BILLING 5-4

TESTING PATIENT PRIVACY, CONFIDENTIALITY, AND HIPAA INFORMATION Genoptix, Inc. is committed to protecting the privacy and security of protected health information (PHI) in our possession, and to complying with all state and federal requirements applicable to the handling and release of medical records and medical information. As a provider of health care services, Genoptix is considered a covered entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Genoptix has developed and implemented certain policies and procedures to ensure its compliance with applicable HIPAA rules and regulations, including those pertaining to Privacy, Security, and Transaction and Code Set Standards. In accordance with the HIPAA Privacy Regulation (45 CFR 164.506), the use and disclosure of protected health information (PHI) (EH) without a specific patient authorization is permitted in order to carry out treatment, payment, or health care operations. The Health Information Technology for Economic and Clinical Health (HITECH) Act is part of the American Recovery and Reinvestment Act (ARRA) of 2009 and amended HIPAA in several respects. Genoptix complies with the additional requirements mandated by this law which includes additional notification requirements for breaches of unsecured protected health information (PHI). Should you have questions regarding Genoptix privacy or confidentiality provisions, please contact us at 800.755.1605. CPT CODES The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients only. Multiple units of service may be billed for CPT codes, and all CPT codes are subject to change. These codes reflect our interpretation of the code descriptions and their application to our testing procedures. Additionally, when testing is performed in combination with other assays, CPT code frequencies may decrease. Because coding accuracy is the responsibility of the billing entity, we request that you reaffirm the appropriateness of these codes by referencing to the most current version of the CPT Coding Manual of the American Medical Association (AMA) at www.ama-assn.org or by visiting the Centers for Medicare and Medicaid Services (CMS) web site at: www.cms.gov/home/medicare.asp

6-1 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING COMPASS® Bone Marrow Evaluation Includes COMPASS consultation report, clinical pathology evaluation, bone marrow morphology (up to 20 stains and/or IHC antibodies), flow cytometry (up to 40 antibodies), cytogenetics and/or FISH (up to 14 probes), and molecular tests as medically necessary. METHODOLOGY Cytochemistry & immunohistochemistry, flow cytometry, chromosome analysis, FISH, and molecular testing as medically necessary. SPECIMEN REQUIREMENTS Bone marrow aspirate: 2-3 mL in green top (sodium heparin) tube. Two (2) bedside smears. Bone marrow core: Fix >1.0 cm (length) of core and/or clot in B-plus vials. Peripheral blood: 2-3 mL in purple top (EDTA) tube. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES Refer to individual test for CPT code(s).

TESTING 6-2

TESTING COMPASS® Blood Evaluation Includes COMPASS consultation report, clinical pathology evaluation, blood morphology (up to 10 cytochemical stains), flow cytometry (up to 40 antibodies), cytogenetics and/or FISH (up to 14 probes), and molecular tests as medically necessary. METHODOLOGY Cytochemistry, flow cytometry, chromosome analysis, FISH, and molecular testing as medically necessary. SPECIMEN REQUIREMENTS Peripheral Blood: 4-5 mL in two (2) green top (sodium heparin) tubes. And, 2-3 mL in purple top (EDTA) tube, if possible. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES Refer to individual test for CPT code(s).

6-3 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING CHART® When serial or subsequent COMPASS® evaluations are requested on the same patient and deemed clinically appropriate by a Genoptix Hematopathologist, Genoptix will automatically provide a CHART report, unless otherwise indicated by the ordering physician. CHART includes all medically necessary technologies, and a consultative review and correlation with relevant prior findings by a Genoptix Hematopathologist. METHODOLOGY Cytochemistry & immunohistochemistry, flow cytometry, chromosome analysis, FISH, and molecular testing as medically necessary. SPECIMEN REQUIREMENTS Bone marrow aspirate: 2-3 mL in green top (sodium heparin) tube. Two (2) bedside smears. Bone marrow core: Fix >1.0 cm (length) of core and/or clot in B-plus vials. Peripheral blood: 2-3 mL in purple top (EDTA) tube. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES Refer to individual test for CPT code(s).

TESTING 6-4

TESTING NexCourse® If one or more solid tumor tests are ordered in a disease state, a NexCourse summary report will be issued. METHODOLOGY FISH and/or molecular testing. SPECIMEN REQUIREMENTS Preferred: Formalin-fixed paraffin embedded (FFPE) block containing non-necrotic tumor tissue, plus one (1) H&E slide cut at 4-5 microns. Alternative: Refer to individual test STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7–10 days CPT CODES Refer to individual test for CPT code(s).

6-5 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | CONSULTATIVE SERVICES Second Opinion Consultation Consultation by a Genoptix Hematopathologist on previously diagnosed cases. We require appropriate clinical data and slides, as well as the most recent morphology report and laboratory test results. METHODOLOGY Case dependent. TURNAROUND TIME Monday through Saturday/7-10 days Incomplete information on a test requisition may cause a delay in reporting. CPT CODES 88321, 88323, 88325, 88312 and/or 88313 x number of newly cut special stains evaluated and reported per unique biopsy specimen, 88342 x 1 Initial immunohistochemical single stain per uniquely identified biopsy specimen, 88341 (xN) number of immunohistochemical stains evaluated after initial stain

TESTING 6-6

TESTING | MORPHOLOGY Bone Marrow Morphology Preparation of blood smears and/or bone marrow core/clot for staining, morphological identification and enumeration of hematopoietic cells. METHODOLOGY H&E, cytochemical and immunohistochemistry SPECIMEN REQUIREMENTS Bone Marrow Aspirate: Four (4) to eight (8) bedside smears or 1 mL in purple-top (EDTA) tube. Bone Marrow Core: Fix >1.0 cm (length) in B-Plus vial. Place B-Plus vial in separate bag. Bone Marrow Clot: Fix >1.0 cm (length) in B-Plus vial. Place B-Plus vial in separate bag. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech only: 2 days With interpretation: 3 days CPT CODES 85097 (x1) if bone marrow aspirate is evaluated and reported 88305 (xN) number of uniquely identified bone marrow biopsy specimens evaluated and reported (e.g., core and clot sections) 88311 (xN) number of uniquely identified bone marrow biopsies decalcified 88312 (xN) number of special stains, microorganisms, evaluated and reported 88313 (xN) number of special stains evaluated and reported per uniquely identified biopsy specimen 88341 (xN) number of immunohistochemical stains evaluated after initial stain 88342 (x1) Initial immunohistochemical single stain per uniquely identified biopsy specimen (e.g., core and clot sections)

Blood Morphology Preparation of blood smears for staining, identification and enumeration of the morphology of blood cells. METHODOLOGY Cytochemical stains SPECIMEN REQUIREMENTS Slides: Two (2) bedside smears or 1 mL of peripheral blood in purple top (EDTA) tube. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech only: 2 days With interpretation: 3 days CPT CODES 85060 x 1 if peripheral blood smear is evaluated and reported

6-7 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | FLOW CYTOMETRY Intelligent Flow Profile (Blood or Bone Marrow) — Global A 24-marker profile, with additional rational marker selection for phenotyping (up to 40 total antibodies). An evaluation of specimen adequacy and cellular integrity will also be performed. Markers include CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD16, CD19, CD20, CD23, CD33, CD34, CD38, CD45, CD56, CD64, CD117, Kappa, Lambda, HLA-DR. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top), EDTA is acceptable Bone marrow aspirate: 2-3 mL in sodium heparin (green top) Bone marrow core: 1-2 cm minimum core length in RPMI Fluids: Equal parts RPMI and specimen STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 24-48 hours CPT CODES 88184, 88185 x 23, 88189

Intelligent Flow Profile (Fresh Tissue) — Global An 18-marker profile, with additional rational marker selection for phenotyping (up to 40 total antibodies). An evaluation of specimen adequacy and cellular integrity will also be performed. Markers include CD2, CD3, CD4, CD5, CD7, CD8, CD10,CD19, CD20, CD23, CD13, CD34, CD38, CD45, CD56, Kappa, Lambda. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Fresh, unfixed tissue: 0.2 cm minimum in RPMI FNA: Equal parts RPMI and specimen STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 24-48 hours CPT CODES 88184, 88185 (x17), 88189

TESTING 6-8

TESTING | FLOW CYTOMETRY Immunophenotyping Profile (Blood or Bone Marrow) — Tech only An immunophenotypic 24-marker profile, including CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD16, CD19, CD20, CD23, CD33, CD34, CD38, CD45, CD56, CD64, CD117, Kappa, Lambda, HLA-DR. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top), EDTA is acceptable Bone marrow aspirate: 2-3 mL in sodium heparin (green top) Bone marrow core: 1-2 cm minimum core length in RPMI Fluids: Equal parts RPMI and specimen STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES 88184, 88185 (x23)

Immunophenotyping Profile (Fresh Tissue) — Tech only An immunophenotypic 18-marker profile, including CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD19, CD20, CD23, CD13, CD34, CD38, CD45, CD56, Kappa, Lambda. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Fresh, unfixed tissue: 0.2 cm minimum in RPMI FNA: Equal parts RPMI and specimen STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES 88184, 88185 (x17)

6-9 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | FLOW CYTOMETRY Intelligent Flow Profile (Blood or Bone Marrow) — Interpretation only Flow immunophenotyping performed at client site and submitted to Genoptix for interpretation. Additional add-on markers may be added for further classification. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Analyzed data transmitted to Genoptix with aliquot of residual sample. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES 88189

CLL MRD Profile — Global Available as a global test only. Markers include CD3, CD5, CD19, CD20, CD22, CD43, CD79b, CD81. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) EDTA is also acceptable. Bone marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 24-48 hours CPT CODES 88184, 88185 (x7), 88187

TESTING 6-10

TESTING | FLOW CYTOMETRY Myeloma MRD Profile — Global Available as a global test only. Markers include CD19, CD20, CD27, CD38, CD45, CD56, CD117, CD138, cKappa, cLambda. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 24-48 hours CPT CODES 88184, 88185 (x9), 88188

PNH Evaluation — Global Available as a global test only. Assessment uses CD14, CD33, CD45, CD55, CD59, FLAER for determination of PNH. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 24-48 hours CPT CODES 88184, 88185 (x5), 88187

6-11 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | FLOW CYTOMETRY Acute Leukemia Panel — Tech only add on Available as a tech-only add-on after initial 24-marker immunophenotypic profile is complete. Assessment uses MPO, CD79a, CD3, CD34, TDT, CD45, CD22, CD41, CD71a, CD235a, CD61 for further evaluation/ determination of ambiguous acute leukemia. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES Additional 88185 (x8) when added to immunophenotyping profile

Mature B-cell Panel — Tech only add on Available as a tech-only add-on after initial 24-marker immunophenotypic profile is complete. Assessment uses CD103, CD25, CD19, CD20, CD11c, CD45, FMC7, CD22, CD5 for determination of B-cell disorders. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) EDTA also acceptable Bone marrow: 2-3 mL in sodium heparin (green top) Fresh, unfixed tissue: 0.2 cm minimum in RPMI FNA: Equal parts RPMI and specimen STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES Additional 88185 (x9) when added to immunophenotyping profile

TESTING 6-12

TESTING | FLOW CYTOMETRY LGL Panel — Tech only add on Available as a tech-only add-on after initial 24-marker immunophenotypic profile is complete. Assessment uses CD57, CD56, CD4, CD8, CD3, CD45, Ta/b, Tg/d, CD16, CD5 for determination of lymphomas to define/ evaluate large granular lymphocytes (LGL) and T-cell disorders. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) EDTA also acceptable Bone marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES Additional 88185 (x10) when added to immunophenotyping profile

Myeloma Panel — Tech only add on Available as a tech-only add-on after initial 24-marker immunophenotypic profile is complete. Assessment uses CD81, CD27, CD28, CD56, CD138, CD19, CD38, CD45, cKappa, cLambda, CD117, CD200 for determination of plasma cell disorders. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6mL in sodium heparin (green top) EDTA also acceptable Bone marrow: 2-3mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES Additional 88185 (x12) when added to immunophenotyping profile

6-13 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | FLOW CYTOMETRY B-cell Clonality — Tech only add on Available as a tech-only add-on after initial 24-marker immunophenotypic profile is complete. Assessment uses cKappa, cLambda, CD5, CD19, CD10, CD11c, CD19, CD20 for evaluation of the presence of monoclonal B-cell population with equivocal, nonspecific or absent expression of surface light chains. METHODOLOGY Flow Cytometry SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) EDTA also acceptable Bone marrow: 2-3 mL in sodium heparin (green top) Fresh, unfixed tissue: 0.2 cm minimum in RPMI FNA: Equal parts RPMI and specimen STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. Transport to lab ASAP. TURNAROUND TIME 12-24 hours CPT CODES Additional 88185 (x8) when added to immunophenotyping profile

TESTING 6-14

TESTING | CYTOGENETICS Chromosome Analysis Detection of chromosomal gains and/or losses, as well as deletions, inversions, or translocations specific to hematopoietic disorders and malignancies. METHODOLOGY Cytogenetics SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 88264, 88280, 88291

FISH Fluorophore-labeled probes for DNA specific targeting of aberrant chromosomes in leukemia, lymphoma, myeloproliferative/myelodysplastic disorders, and solid tumors. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 3-5 days CPT CODES 88377 manual or 88374 automated

6-15 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | CYTOGENETICS ALL FISH Profile Assessment uses BCR-ABL t(9;22), MLL (11q23), ETV6-RUNX1 t(12;21), IGH (14q32), TCRα/δ (14q11) for determination of acute lymphoblastic leukemia. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x5) automated or 88377 (x5) manual

AML FISH Profile Assessment uses RUNX1T1/RUNX1 t(8;21), PML-RARA t(15;17), RARA (17q21), CBFβ inv(16), MLL (11q23) for determination of acute myeloid leukemia. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x5) automated or 88377 (x5) manual

TESTING 6-16

TESTING | CYTOGENETICS CLL FISH Profile Assessment uses ATM (11q22), +12 (12cen), 13q-/-13, TP53 (17p13) for determination of chronic lymphocytic leukemia. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374, 88367, 88373 (x2) automated or 88377, 88368, 88369 (x2) manual

CML FISH Profile Assessment uses BCR-ABL/ASS1 t(9;22), +8 (8cen), RARA (17q21) for determination of chronic myeloid leukemia. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x2), 88367 automated or 88377 (x2), 88368 manual

6-17 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | CYTOGENETICS MYELOMA FISH Profile Assessment uses CKS1B/CDKN2C (1p/1q), 5q-/-5/+5, 13q-/-13, TP53 (17p13), IGH/FGFR3 t(4;14), IGH/CCND1 t(11;14), IGH-MAF t(14;16) for determination of plasma cell disorders. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x6), 88367 automated or 88377 (x6), 88368 manual

MDS FISH Profile Assessment uses 5q-/-5/+5, 7q-/-7, +8 (8cen), 20q for determination of myelodysplasic syndrome. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x2), 88367, 88373 automated or 88377 (x2), 88368, 88369 manual

TESTING 6-18

TESTING | CYTOGENETICS MPN FISH Profile Assessment uses BCR-ABL/ASS1 t(9;22), 5q-/-5/+5, 7q-/-7, +8 (8cen), 20q- for determination of myeloproliferative neoplasms. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x3), 88367, 88373 automated or 88377 (x3), 88368, 88369 manual

MPN — Eosinophilia FISH Profile Assessment uses PDBGRα (4q12), PDGFRβ (5q32), FGFR1 (8p11) for determination of eosinophilia. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x3) automated or 88377 (x3) manual

6-19 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | CYTOGENETICS B-cell NHL FISH Profile Assessment uses IGH/CCND1 t(11;14), IGH/BCL2 t(14;18), MYC (8q24), BCL6 (3q27), MALT1 (18q21), 6q21/6q23 for determination of lymphoma subtypes. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Peripheral Blood: 5-6 mL in sodium heparin (green top) Bone Marrow: 2-3 mL in sodium heparin (green top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88374 (x6) automated or 88377 (x6) manual

ALK Rearrangement The FDA approved Vysis® ALK Break Apart FISH Probe Kit is a qualitative test that detects rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks containing tumor tissue from the most recent surgery or biopsy. Alternative: Two (2) to Three (3) unstained FFPE tissue sections recently cut at 4 μm thickness on glass slides per marker, plus accompanying H&E stained slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 7 days CPT CODES 88377 manual or 88374 automated

TESTING 6-20

TESTING | CYTOGENETICS FGFR1 Amplification Fibroblast growth factor receptor type 1 gene (FGFR1) amplification by fluorescent in situ hybridization (FISH). FGFR1 overexpression has been identified as a driver event in breast carcinoma and non-small cell lung cancer (NSCLC), particularly squamous cell carcinoma. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks containing tumor tissue from the most recent surgery or biopsy. Alternative: Two (2) to Three (3) unstained FFPE tissue sections recently cut at 4 μm thickness on glass slides per marker, plus accompanying H&E stained slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 88377 manual or 88374 automated

HER2 Amplification Assessment of HER2 gene amplification by FISH in human breast and gastric cancer tissue specimens. Up to 20% of breast cancers overexpress the HER2 receptor. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks containing tumor tissue from the most recent surgery or biopsy. Alternative: Two (2) to Three (3) unstained FFPE tissue sections recently cut at 4 μm thickness on glass slides per marker, plus accompanying H&E stained slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 5 days CPT CODES 88377 manual or 88374 automated

6-21 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | CYTOGENETICS MET Amplification Assessment of MET gene amplification by FISH. Alterations of the MET proto-oncogene lead to tumorigenesis and have been described in various solid tumors including lung, gastric, head and neck and brain cancers. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks containing tumor tissue from the most recent surgery or biopsy. Alternative: Two (2) to Three (3) unstained FFPE tissue sections recently cut at 4 μm thickness on glass slides per marker, plus accompanying H&E stained slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 7 days CPT CODES 88377 manual or 88374 automated

RET Rearrangement RET gene rearrangement is present in up to 1~2% of non-small cell lung cancer (NSCLC), defining a molecular subset of tumors that are mutually exclusive from those caused by EGFR or KRAS mutations, and ALK or ROS1 rearrangements. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks containing tumor tissue from the most recent surgery or biopsy. Alternative: Two (2) to Three (3) unstained FFPE tissue sections recently cut at 4 μm thickness on glass slides per marker, plus accompanying H&E stained slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 88377 manual or 88374 automated 

TESTING 6-22

TESTING | CYTOGENETICS ROS1 Rearrangement ROS1 rearrangement is present in up to 2% of non-small cell lung cancer (NSCLC), defining a molecular subset with distinct clinical characteristics that are similar to those observed in patients with ALK rearranged NSCLC. METHODOLOGY Flourescence in-situ hybridization (FISH) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks containing tumor tissue from the most recent surgery or biopsy. Alternative: Two (2) to Three (3) unstained FFPE tissue sections recently cut at 4 μm thickness on glass slides per marker, plus accompanying H&E stained slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME Tech-only: 3 days With interpretation: 7 days CPT CODES 88377 manual or 88374 automated

6-23 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | MOLECULAR ABL1 Kinase Domain Mutation Detection of mutations in the ABL1 kinase domain for patients with BCR-ABL1 positive CML or ALL. RNA is isolated, reverse transcribed to complementary DNA (cDNA), and the DNA sequence of targeted regions of ABL (exons 4, 6-7) is determined using next generation sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10-12 days CPT CODES 81403

AML Molecular Profile Detection of mutations in key genes recurrently mutated in AML. Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequence of targeted regions of the ASXL1, TET2, PHF6, DNMT3A, IDH1/2, FLT3, NPM1, and KIT genes is determined using next-generation sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES 81450

TESTING 6-24

TESTING | MOLECULAR B-cell Clonality Assessment The detection of clonal B-cell immunoglobulin heavy chain (IGH) gene rearrangement by PCR of variable and joining regions on chromosome 14. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81261

BRAF Mutation Analysis BRAF V600E mutations are present in approximately 12% of colorectal adenocarcinomas. BRAF mutation analysis includes sectioning of FFPE tumor tissue followed by H&E staining of the tumor-rich region. DNA is extracted from a microdissected tumor section and the presence of the V600E mutation is identified by PCR. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Preferred: Two (2) formalin fixed paraffin embedded (FFPE) blocks containing tumor tissue from most recent surgery or biopsy. Alternative: Six (6) to eight (8) unstained slides at 10 μm thickness. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81210

6-25 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | MOLECULAR CALR Mutation Analysis Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequence of targeted regions of the CALR gene is determined using next generation sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 9 days CPT CODES 81479

CEBPA Mutation Analysis The CCAAT/enhancer binding protein alpha (CEBPA) is a key transcription factor involved in granulocyte maturation. A mutation in CEBPA is expected to interfere with DNA binding and/or dimerization. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7-10 days CPT CODES 81403 

TESTING 6-26

TESTING | MOLECULAR cKIT (D816V) Mutation Analysis KIT mutations are present in the majority of cases of mast cell disease/systemic mastocytosis. Patient DNA is isolated and subjected to allele-specific PCR amplification. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7-10 days CPT CODES 81402

cobas® BRAF V600 Mutation The cobas® 4800 BRAF V600 Mutation Test is an in vitro diagnostic device intended for the qualitative detection of the BRAF V600E mutation in DNA extracted from formalin fixed, paraffin-embedded human melanoma tissue. The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR test on the cobas 4800 system, and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with vemurafenib. The cobas® 4800 BRAF V600 Mutation Test does not reliably detect non-V600E mutations. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Preferred: Two (2) FFPE blocks: One containing tumor tissue from the most recent surgery or biopsy and another normal tissue. Alternative: One (1) to two (2) unstained formalin fixed paraffin embedded (FFPE) tissue sections cut at 5 μm thickness on glass slides, plus accompanying H&E. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81210

6-27 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | MOLECULAR EGFR Mutation Analysis DNA is extracted from microdissected tumor cells and the presence of any of 21 possible EGFR mutations in exons 18-21 (including the T790M mutation in exon 20) is identified by real-time polymerase chain reaction. The test is intended to be used to select patients with NSCLC for whom tyrosine kinase inhibitor (TKI) may be indicated. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Preferred: Two (2) formalin fixed paraffin embedded (FFPE) blocks containing tumor tissue from the most recent surgery biopsy. Alternative: Two (2) unstained slides at 5 μm thickness, plus accompanying H&E. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81235

FLT3 Mutation Analysis FLT3 ITD and TKD regions are analyzed by PCR. Internal tandem duplication (ITD) is the most frequent mutation in the FLT3 gene and is associated with a poor prognosis in AML. Polymerase chain reaction (PCR) amplification for the detection of the FLT3 ITD and FLT3 TKD mutations is performed on DNA isolated from the patient sample. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7-10 days CPT CODES 81245, 81246

TESTING 6-28

TESTING | MOLECULAR FLT3/NPM1 Mutation Analysis FLT3 ITD and TKD regions are analyzed in addition to NPM1 exon 12. Internal tandem duplication (ITD) is the most frequent mutation in the FLT3 gene. Polymerase chain reaction (PCR) amplification for the detection of the FLT3 ITD, FLT3 TKD, and NPM1 mutations is performed on DNA isolated from the patient sample. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7-10 days CPT CODES 81245, 81246, 81310

GenoTRACE® Quantitative BCR-ABL Quantitative real-time PCR is used for the detection of t(9;22) BCR-ABL1 fusion transcripts that result in p190, p210, or p230 fusion proteins. Analytical sensitivity is 0.0032% on the International Scale (IS). Minimal residual disease monitoring results for the major (p210 fusions) are reported and graphed on the IS scale. Monitoring results for the minor and micro fusion breakpoints are reported. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 4 days CPT CODES 81206 (major breakpoints), 81207 (minor breakpoints), 81208 (other breakpoints)

6-29 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | MOLECULAR IgVH Hypermutation Analysis Somatic hypermutation of the IGH V region occurs naturally during B-cell maturation in lymphoid follicles. DNA sequencing of the amplified IGH gene variable (V) region is performed and is compared to the germline (unmutated) consensus sequence. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 8 days CPT CODES 81263

JAK2 Exon 12/13 JAK2 encodes for a protein tyrosine kinase involved in activated signaling. Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequences of JAK2 exons 12-14 are determined using next generation sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 9 days CPT CODES 81403

TESTING 6-30

TESTING | MOLECULAR JAK2 V617F Mutation Analysis JAK2 mutation results in the constitutive action of the JAK2 tyrosine kinase and is present in the majority of patients with polycythemia vera, and in a subset of other myeloproliferative neoplasms. Constitutive action of the JAK2 tyrosine kinase results in myeloproliferation in these disorders. JAK2 mutation analysis includes isolation of genomic DNA, gene amplification by quantitative PCR and probe analysis to determine the presence of the V617F (1849G>T) mutation. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 4 days CPT CODES 81270

KRAS Mutation Analysis Detection of seven somatic mutations in the human KRAS oncogene. DNA extracted from formalin-fixed paraffin-embedded tissue is analyzed by PCR. RAS mutations are frequently associated with poor response to therapies that target the epidermal growth factor receptor (EGFR). METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Preferred: Two (2) formalin fixed paraffin embedded (FFPE) blocks containing tumor tissue from most recent surgery or biopsy. Alternative: Six (6) to eight (8) unstained slides at 10 μm thickness. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81275 

6-31 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | MOLECULAR MDS Molecular Profile Detection of mutations in key genes recurrently mutated in MDS. Genomic DNA is isolated and the DNA sequence of targeted regions of the TP53, EZH2, ETV6, RUNX1, and ASXL1 genes is determined using nextgeneration sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES 81540

Melanoma Molecular Profile Detection of mutations in key genes recurrently mutated in melanoma. Genomic DNA is isolated from tissue and the DNA sequence of targeted regions of the BRAF, NRAS and c-KIT genes is determined using nextgeneration sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Preferred: Two (2) formalin fixed paraffin embedded (FFPE) blocks containing tumor tissue from the most recent surgery or biospy. Alternative: Eight (8) unstained slides at 10 μm thickness, plus accompanying H&E. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES 81404 (x2), 81406, 88381 

TESTING 6-32

TESTING | MOLECULAR MLL-PTD Mutation Analysis A significant fraction of myelodysplastic syndromes (MDS) and MDS/acute myeloid leukemia (AML) patients have MLL partial tandem duplications (MLL-PTD). Patient RNA from peripheral blood or bone marrow is isolated and reverse transcribed to complementary DNA (cDNA). Partial tandem duplications (PTD) between exons 2 and 8 in the MLL (mixed lineage leukemia) gene are amplified using multiplexed quantitative PCR. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 8 days CPT CODES 81479

MPL Mutation Analysis MPL encodes for the thrombopoietin receptor, an important growth and survival factor for megakaryocytes. Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequence of exon 10 including W515L/K and S505 is determined using next generation sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 9 days CPT CODES 81403 

6-33 TESTING

GENOPTIX DIRECTORY OF SERVICES

TESTING | MOLECULAR MPN Molecular Profile Detection of mutations in key genes recurrently mutated in MPNs. Genomic DNA is isolated and the DNA sequence of targeted regions of the CALR, CSF3R, JAK2, MPL and SETBP1 genes is determined using nextgeneration sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10-12 days CPT CODES 81450

MSI Analysis PCR and fragment analysis of paired normal and tumor tissue to determine microsatellite instability (MSI) at the standard five NCI-recommended loci. Positive results are reported as MSI-high (at least two markers are unstable) or MSI-low (one marker is unstable). METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Preferred: Two (2) formalin fixed paraffin embedded (FFPE) blocks: One containing tumor tissue from the most recent surgery or biopsy and another normal tissue. Alternatively for Normal tissue PB can be used. Alternative: Seven (7) unstained slides for tumor, seven (7) unstained slides for normal at 10 μm thickness. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81301

TESTING 6-34

TESTING | MOLECULAR Myeloid Molecular Profile Detection of mutations in key genes recurrently mutated in myeloid malignancies. Genomic DNA is isolated and the DNA sequence of targeted regions of the SF3B1, U2AF1, SRSF2, ZRSR2, EZH2, ASXL1, DNMT3A, TET2, IDH1, IDH2, SETBP1, RUNX1, ETV6,TP53,PHF6, NRAS, CBL, KIT, JAK2, MPL, and NPM1 genes is determined using next-generation sequencing technology. METHODOLOGY Next-Generation Sequencing (NGS) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES 81450

NPM1 Mutation Analysis Exon 12 of NPM1 is analyzed by PCR to detect small insertion mutations specific to AML. Polymerase chain reaction (PCR) amplification for the detection of NPM1 mutations is performed on DNA isolated from the patient sample. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7-10 days CPT CODES 81310 

6-35 TESTING

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TESTING | MOLECULAR PML/RARA Quantitative Analysis RT-PCR for quantitative detection of t(15;17) PML/RARA, a recurrent genetic abnormality found in a subset of patients with acute promyelocytic leukemia (APL). This test detects all three gene fusion patterns: type A (short, S-form, bcr-3), type B (long, L-form, bcr-1), and type B variant (variable, V-form, bcr-2). This quantitative assay allows PML/RARA levels to be monitored rather than simply detecting the presence or absence of disease. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7-10 days CPT CODES 81315 

Prosigna® Breast Cancer Prognostic Gene Signature Assay The Prosigna Breast Cancer Prognostic Gene Signature Assay is an invitro diagnostic assay which is performed on the NanoString® nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence of disease. SPECIMEN REQUIREMENTS Preferred: Formalin-fixed, minimum 4mm paraffin-embedded (FFPE) viable invasive breast carcinoma (ductal, lobular, mixed, or NOS) with at least 10% tumor cellularity. Alternative: Six (6) unstained slides (minimum of 3), each 10 microns in thickness. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES 81599

TESTING 6-36

TESTING | MOLECULAR T-cell Clonality Assessment Detection of clonal TCR-beta gene rearrangements by PCR of variable and joining regions on chromosome 7. METHODOLOGY Polymerase Chain Reaction (PCR) SPECIMEN REQUIREMENTS Peripheral Blood: 2-3 mL in EDTA (purple top) Bone Marrow: 2-3 mL in EDTA (purple top) STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 7 days CPT CODES 81340

6-37 TESTING

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TESTING IHC4 (ER, PR, Ki-67, HER2 with recurrence risk score) The immunohistochemical 4 (IHC4) score is a prognostic score for recurrence risk assessment that is a quantitative measurement of estrogen and progesterone expression by AQUA® Technology, the Ki-67 expression percentage by AQUA Technology, and the HER2 expression status by IHC or FISH testing. METHODOLOGY Automated Quantitative Analysis (AQUA) Technology and IHC or FISH. SPECIMEN REQUIREMENTS Preferred: Formalin-fixed paraffin embedded (FFPE) tissue containing sufficient tumor cells for analysis. Large, preferably multiple core biopsies or properly fixed excisional biopsy, representative of tumor grade. Acceptable alternative: At least ten (10) unstained slides at 4 microns, plus one (1) accompanying H&E slide. STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME 10 days CPT CODES Refer to individual test for CPT code(s).

TESTING 6-38

TESTING Estrogen Receptor (ER) Estrogen receptor (ER) by AQUA Technology is reported as either negative or positive with the cutoff score = 11. A score 11 indicates positive ER expression. If all markers for IHC4 are performed and ER result is negative, an IHC4 residual recurrence risk score and recurrence rate will not be reported. ER expression by IHC is measured in accordance with CAP/ASCO guidelines. Receptor expression is detected by binding of a monoclonal rabbit anti-human ER antibody (clone SP1). ER status is determined by the percentage of stained cells. METHODOLOGY Automated Quantitative Analysis (AQUA) or IHC SPECIMEN REQUIREMENTS Preferred: Formalin-fixed paraffin embedded (FFPE) block containing non-necrotic tumor tissue, plus one (1) H&E slide cut at 4-5 microns. Acceptable alternative: Four (4) positively charged unstained slides cut at 4-5 microns, plus one (1) accompanying H&E slide (required). STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME AQUA Technology: 7-10 days IHC: 2 days CPT CODES AQUA Technology: 88313, 88361 (x2) IHC: 88360 tumor IHC, manual or 88361 tumor IHC, computer assisted

6-39 TESTING

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TESTING Progesterone Receptor (PR) Progesterone receptor (PR) by AQUA Technology is reported as either negative or positive with the cutoff = 30. A score >30 indicates positive ER expression. PR expression by IHC is measured in accordance with CAP/ASCO guidelines. Receptor expression is detected by binding of a monoclonal mouse anti-PR antibody (clone 1E2). PR status is determined by the percentage of stained cells. METHODOLOGY Automated Quantitative Analysis (AQUA) or IHC SPECIMEN REQUIREMENTS Preferred: Formalin fixed paraffin embedded (FFPE) block containing non-necrotic tumor tissue, plus one (1) H&E slide cut at 4-5 microns. Acceptable alternative: Four (4) positively charged unstained slides cut at 4-5 microns, plus one (1) accompanying H&E slide (required). STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME AQUA Technology: 7-10 days IHC: 2 days CPT CODES AQUA Technology: 88313, 88361 (x2) IHC: 88360, manual or 88361, computer assisted

TESTING 6-40

TESTING Ki-67 Ki-67 is a nuclear protein expressed in proliferating cells and its expression is detected by either IHC or AQUA technology. Ki-67 by AQUA Technology is reported as a percentage of expression ranging between 0-100%. Ki-67 by IHC is detected by a monoclonal rabbit anti-human Ki-67 antibody (clone 30-9). Ki-67 expression status is determined by the percentage of stained tumor cells. METHODOLOGY Automated Quantitative Analysis (AQUA) or IHC SPECIMEN REQUIREMENTS Preferred: Formalin fixed paraffin embedded block containing non-necrotic tumor tissue, plus one (1) H&E slide cut at 4-5 microns. Acceptable alternative: Four (4) positively charged unstained slides cut at 4-5 microns, plus one (1) accompanying H&E slide (required). STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME AQUA Technology: 7-10 days IHC: 2 days CPT CODES AQUA Technology: 88313, 88361 (x2) IHC: 88360 manual or 88361 computer assisted

HER2 HER2 (c-erbB-2) expression by IHC is measured in accordance with CAP/ASCO Guidelines. HER2 expression level is detected by binding of a monoclonal rabbit anti-human HER2 antibody (clone 4B5). HER2 expression level is determined by the percentage of tumor cells with complete or intense staining. METHODOLOGY IHC SPECIMEN REQUIREMENTS Preferred: Formalin fixed paraffin embedded block containing non-necrotic tumor tissue, plus one (1) H&E slide cut at 4-5 microns. Acceptable alternative: Four (4) positively charged unstained slides cut at 4-5 microns, plus one (1) accompanying H&E slide (required). STORAGE AND TRANSPORT Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE. TURNAROUND TIME IHC: 2 days CPT CODES IHC: 88360 manual or 88361 computer-assisted 6-41 TESTING

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LIBRARIES AND CODES SPECIAL STAINS

Alcian Blue/PAS Alcian Blue Alcian Blue & Hyaluronidase Amyloid (crystal violet) Argyrophil (carcinoid) Argentaffin Basement membrane (Gomori) Bile Colloidal Iron with/without hyaluronidase Congo Red Copper Diff Quik Elastic Giemsa

Iron Keratin (Ayoub-Shklar) Melanin (Fontana-Masson) Melanin-Bleach Methyl Green Pyronine Movat’s Pentachrome Mucicarmine Oil Red O PTAH Reticulum Toluidine Blue (mast cell) Trichrome Victoria Blue Wright Giemsa

SPECIAL STAINS— ORGANISMS

AFB Brown & Hopps (Bacteria) Fite Giemsa GMS

Gridley PAS (-Diastase) PAS (+Diastase) Steiner & Steiner (Spirochetes)

IMMUNOHISTOCHEMISTRY (IHC)

34BE12 (CK 903) AACT AAT ACTH Actin AE1/AE3 AFP Alk-1 Protein Annexin Arginase-1 Bcl-2 oncoprotein Bcl-6 Ber-EP4 Beta-Catenin B72.3 C4d Calcitonin Caldesmon Calponin Calretinin CAM5.2 Carbonic Anhydrase (CAIX) CD1a CD2 CD3 CD4 CD5 CD7 CD8 CD10 CD11c CD14 CD15 CD19 CD20 CD21 CD22 CD23 CD25 CD30

CD31 CD33 CD34 CD42b CD43 (Leu22) CD45 (LCA) CD45RO (UCHL-1) CD56 CD57 (Leu7) CD61 CD68 (KP1) CD71 CD79a CD99-MIC-2 CD103 CD117,c-kit CD123 CD138 CD163 CDX-2 CEA (Monoclonal) CEA (Polyclonal) Chromogranin A CK5 CK7 CK19 CK20 Cyclin D1(Bcl-1) CMV D2-40 DBA.44 (HCL) Desmin DOG-1 E-Cadherin EBV (EBER) by ISH EBV-LMP EMA ER Factor VIII Factor XIIIa LIBRARIES AND CODES 7-1

LIBRARIES AND CODES IMMUNOHISTOCHEMISTRY (IHC) CONTINUED

7-2 LIBRARIES AND CODES

Fascin FSH Galecton-3 Gastrin GATA-3 GCDFP (BRST-2) GFAP Glucagon Glutamine synthetase Glycophorin-A Glypican-3 Granzyme B Growth Hormone HBME-1 HCG Beta Helicobacter pylori Hepatitis B Core Ag Hepatitis B Surface Ag Hep-Par1 (Hepat Sp Ag) Herpes type 1 (HSV1) Herpes type 2 (HSV2) Hemoglobin A HHV8 HMB45 Ig A Ig D Ig G Ig M Inhibin-A Insulin Kappa Kappa by ISH Ki-67 (MIB-1) Lambda Lambda by ISH Laminin LH Lysozyme (Muramidase) Mammaglobin MART-1 MITF MLH1 MOC-31 MSH2 MSH6 MUM-1 Myelin Basic Protein Myeloperoxidase Myogenin Myoglobin Napsin A Neurofilament NSE

OCT 3/4 OSCAR — broad spectrum keratin P504S P16 P40 P53 P57 P63 P120-Catenin Pancreatic Polypeptide Parvovirus Pax-2 Pax-5 Pax-8 PTH Perforin PG-M1 PIN-4 (Prostate triple stain) Placental Alk. Phos. (PLAP) Placental Lactogen (PLAC) PMS2 PR Prolactin PSA Prostatic Acid Phos. (PAP) RCC S100 S100P SALL4 Serotonin Smooth Muscle Actin SMMHC (sm musc myosin heavy chain) Somatostatin SOX10 SV40 Synaptophysin T-bet TdT Thyroglobulin TSH TTF-1 TIA-1 Toxoplasma gondii TRAP TTF-1 Tyrosinase Tryptase (Mast Cell) Ubiquitin Uroplakin II Villin Vimentin WT-1 ZAP-70

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LIBRARIES AND CODES FLOW MARKER

DESCRIPTION

CD1a

Dendritic cells in dermis/epidermis; myeloid leukemias, some B-cell malignancies; dendritic cells in most peripheral C-TLL.

CD2

Majority of thymocytes, almost all peripheral T-cells and NK cells.

CD3

Mature T-cells; most T-cell lymphomas.

CD4

Thymocytes, mature T-cells, helper/inducer T-cells; T-cell leukemias.

CD5

T-cells, peritoneal B-cells. Usually found on CLL cells.

CD7

Immature/mature peripheral T-cells; T-ALL, Sézary Syndrome, C-TLL. Peripheral T-NHL.

CD8

Suppressor/cytotoxic T-cells, thymocytes, NK cell subsets; LGL, T-ALL, some AML.

CD10

Common Acute Lymphoblastic Leukemia Antigen (CALLA); B-ALL, follicular lymphoma.

CD11b

Leukocyte Adhesion Receptor: leukocytes, NK cells; HCL, some AML.

CD11c

Leukocyte Adhesion Receptor; monocytes/macrophages, granulocytes; most HCL, some AML.

CD13

Monocytes, myeloid cells; AML.

CD14

Macrophages/monocytes, subset of granulocytes; some AML.

CD15

CD15 is present on >95% of granulocytes including neutrophils and eosinophils and to a lesser degree on monocytes. It can also be expressed in patients with Hodgkin’s lymphoma, some B-cell chronic lymphocytic leukemia, acute lymphoblastic leukemias.

CD16

IgG Fc Receptor; NK cells, granulocytes, neutrophils; LGL.

CD19

Most B-cells; B-ALL, mature B-cell neoplasms.

CD20

Mid-maturity B-cells, target for rituximab (Rituxan®). Variations in CD20 expression may occur over time; some B-ALL, most mature B-cell neoplasms.

CD22

B-lymphocyte cell adhesion molecule (BL-CAM); B-cells; B-ALL.

CD23

Activated, mature B cells; B-CLL. B-cell composition should be less than 25% of total number of lymphocytes in peripheral blood. Increased CD23 blood levels connote an unwanted proliferation of B-cells.

CD24

CD24 is a GPI-linked protein that is present on the surface of neutrophils. In paroxysmal nocturnal hemoglobinuria (PNH), the absence or deficiency of CD24 is useful in identifying PNH clones on granulocytes.

CD25

Activated B-, T-macrophages, monocytes, NK cells; HCL, T-PLL, T-cell leukemia/lymphoma.

CD26

Present on peripheral blood T lymphocytes, the CD26 antigen is upregulated on PHA- and Con A-stimulated peripheral blood mononuclear cells (PBMCs). The CD26 antigen is found on approximately 50% of CD4 and approximately 30% of CD8 cells. It is also found on EBVtransformed B-cell lines, hairy-cell leukemia, and macrophages. Recently CD26 has been shown to be negative on Sézary syndrome patient T lymphocytes.

CD27

An antigen that is strongly positive on 100% of normal plasma cells, weak to negative on 40-50% of myeloma cases. Recommended for diagnosis and monitoring.

CD28

An antigen that is negative to weak on normal plasma cells and strongly positive on 15-45% of myeloma cases. Recommended for diagnosis and monitoring.

CD33

Peripheral blood monocytes (PBMC), myeloid progenitor cells in bone marrow, granulocytes; AML.

CD34

Human Progenitor Cell Antigen; immature hematopoietic precursor cells; identification and classification of acute leukemias, including PML and T-ALL. Not lineage specific.

CD38

Immature, lymphoid progenitor cells, thymocytes, natural killer cells, active T-, B-cell subsets, plasma cells; peripheral T-cell lymphomas, some B-cell lymphomas. CD38 expression of greater than 20% is predictive for poor prognosis with a potential clinical course requiring earlier and ongoing therapy in CLL. Expression of less than 20% is associated with a favorable disease course requiring minimal or no therapy.

CD41a

Platelet GPIIb. Platelets, megakaryocytes, megakaryoblasts; AML-M7, blasts in transient myeloproliferative disorder.

LIBRARIES AND CODES 7-3

LIBRARIES AND CODES FLOW MARKER

DESCRIPTION

CD43

Most T-cells, activated B-cells; classification of T-cell and low-grade B-cell lymphoma, most ALL, almost all Burkitt’s, T/NK-cell lymphomas, CLL MRD.

CD45

All hematopoietic cells, bright in lymphocytes.

CD55

Decay Accelerating Factor, all hematopoietic cells; reduction or loss of both CD55 and CD59 on erythrocytes and granulocytes produce paroxysmal nocturnal hemoglobinuria, (PNH).

CD56

Neural Cell Adhesion (N-CAM). NK cells, activated T-cells; LGL.

CD57

NK cells, T-cell subsets, some monocytes; LGL.

CD59

Reactive lysis inhibitor, expression on erythrocytes important for survival; reduction or loss of both CD59 and CD55 on erythrocytes and granulocytes produce paroxysmal nocturnal hemoglobinuria (PNH).

CD61

Platelet glycoprotein IIb/IIIa. Platelets, megakaryocytes, myeloid progenitor cells; AML-M7, some AMl-M6, blasts in transient myeloproliferative disorders.

CD64

FC gamma RI. Macrophages/monocytes, activated granulocytes, early myeloid cells; AML M0-M2, M3 usually, M4, M5.

CD71

All proliferating cells in addition to iron requiring cells; AML-M6, primary effusion lymphoma.

CD79a

Ig-alpha protein of the B-cell antigen receptor, expressed in early B-cell differentiation; ALL, B-cell lymphoproliferative disorders.

CD79b

MB-1, B-cell antigen receptor complex associated protein alpha-chain: B-cells, plasma cells; expressed early in B-cell differentiation; B-cell leukemia/lymphoma, classic Hodgkin lymphoma, CLL MRD.

CD81

Lymphocytes, endothelial cells; diffuse large B-cell lymphoma, Burtkitt’s lymphoma cell lines, CLL MRD.

CD103

Mucosal lymphocyte antigen; activated T- and B-cells and monocytes; HCL, some splenic lymphomas.

CD117

Hematopoietic progenitor cells; AML, CML, Hodgkin’s lymphoma. Receptor for c-kit protein, a 145kD tyrosine kinase growth factor receptor protein important in development of hematopoietic stem cells. Tyrosine kinase activity of c-kit and BCR-ABL overexpression in CML is inhibited by Imatinib Mesylate.

CD123

This marker will help to differentiate AML, B ALL, hematogones and dendritic cells. It is also a marker found on Hairy cell leukemias. CD123 is expressed by myeloid precursors, macrophages, dendritic cells, mast cells, basophils, and megakaryocytes.

CD138

Syndecan-1. B-cell precursors, mature B-cells, plasma cells; myeloma, primary effusion lymphoma.

CD200

An antigen that is weakly positive on normal plasma cells and strongly positive on myeloma cases.

Ep Cam

Epithelial Cell Adhesion Molecule

FLAER

Alexa 488 labeled protein and variant of aerolysin. Used to detect the presence of GPI anchor (PNH cells lack ability to produce the GPI anchor so FLAER cannot bind).

FMC-7

Some B-cells; PLL, HCL, splenic lymphoma.

CD235a

GPH-A. Glycophorin, erythroid cells; AML-M6.

Heavy Chains

Malignant plasma cells; heavy chain disease, marginal zone B-cell lymphoma, NHL, diffuse large B-cell lymphoma, ALL.

HLA-DR

B-cells, activated T-cells, monocytes; B-cell leukemia/lymphoma, most AML, peripheral T-cell leukemias.

Kappa / Lambda

Surface kappa light chain found on two thirds of differentiated B-cells. Skewing of ratios between kappa and lambda are indicative of clonality. Allows for identification of unique phenotypes (kappa/lambda/CD19/CD5) for MRD monitoring and provides indication of clonal expansion.

MPO

Myeloperoxidase. T-cells and myeloid cells; AML.

TCR a/b/g/d

T-cell receptor; consists of a, b, g, and d chains.

Tdt

Terminal Deoxynucleotidyl Transferase. Cortical thymocytes and precursor B-cells; ALL, AML and lymphoblastic lymphoma.

7-4 LIBRARIES AND CODES

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LIBRARIES AND CODES DISEASE ABBREVIATIONS

ALL

Acute Lymphoblastic Leukemia

AML

Acute Myeloid Leukemia

B-ALL

B-cell Acute Lymphoblastic Leukemia

CLL

Chronic Lymphocytic Leukemia

CML

Chronic Myelogenous Leukemia

CTLL

Cutaneous T-cell Leukemia/Lymphoma

HCL

Hairy Cell Leukemia

LGL

Large Granulocytic Leukemia

NK

Natural Killer

PLL

Prolymphocytic Leukemia

PML

Promyelocytic Leukemia

T-ALL

T-cell Acute Lymphoblastic Leukemia

T-NHL

T-cell Non-Hodgkins Lymphoma

T-PLL

T-cell Prolymphocytic Leukemia

MDS

Myelodysplastic Syndromes

MPN

Myeloproliferative Neoplasms

AEL

Acute Eyrthroid Leukemia

MM

Multiple Myeloma

WM

Waldenström Macroglobulinemia

AMY

Amyloidosis

PNH

Paroxysmal Nocturnal Hemoglobinuria

AA

Aplastic Anemia

ITP

Idiopathic Thrombocytopenic Purpura

TTP

Thrombotic Thrombocytopenic Purpura

LIBRARIES AND CODES 7-5

LIBRARIES AND CODES INDICATION

ALL

AML

CLL

LPD

CML

MDS

MPN

FISH PROBE

ABNORMALITY DETECTED

USE

BCR-ABL

t(9;22)

Ph Chromosome

MLL

11q23 rearrangements

IGH

14q32 rearrangements

ETV6/RUX1

t(12;21)

TCRa/d

T-cell gene rearrangements

RUX1T1/RUX1

t(8;21)

MLL

11q23 rearrangements

RARA

t(15;17), t(11;17), t(5;17)

APL

PML/RARA

t(15;17)

APL

CBFβ/MYH11

inv(16)

ATM

11q22 deletion

CEP12

Trisomy 12

13q14

13q14 deletion

IGH

14q32 rearrangements

TP53

17p13 deletion

6q21/6q23

6q deletion

CEP12

Trisomy 12

BCR/ABL

t(9;22)

Ph Chromosome

CEP8

Trisomy 8

Accelerated Phase

ASS1

9q34 deletion

Accelerated Phase

RARA

iso(17q)

Accelerated Phase

EGR1

-5 or 5q deletion

D7S486

-7 or 7q deletion

CEP8

Trisomy 8

D20S108

-20 or 20q deletion

EGR1

-5 or 5q deletion

D7S486

-7 or 7q deletion

CEP8

Trisomy 8

BCR/ABL

t(9;22)

D20S108

-20 or 20q deletion

PDGFRa

4q12 rearrangements

Mastocytosis

PDGFRb

5q32 rearrangements

CMML

FGFR1

8p11 rearrangements

Eosinophils

7-6 LIBRARIES AND CODES

B-ALL

T-ALL

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LIBRARIES AND CODES INDICATION

Myeloma

Lymphoma

Miscellaneous

FISH PROBE

ABNORMALITY DETECTED

USE

EGR1

Polysomy 5

Hyperdiploidy

CEP7/D7S486

Polysomy 7

Hyperdiploidy

13q14

13q14 deletion, monosomy 13

IGH

14q32 rearrangements

TP53

17p13 deletion, polysomy 17

IGH/CCNDI

t(11;14), polysomy 11q

IGH/FGFR3

t(4;14)

IGH/MAF

t(14;16)

6q21/6q23

6q deletion

CKS1B/CDKN2C

1p/1q rearrangement

ALK

t(2;5)

ALCL

BCL6

3q27 rearrangements

Non-Burkitt NHL

IGH/MYC

t(8;14)

Burkitt

IGH/CCND1

t(11;14)

Mantle Cell

IGH

14q32 rearrangements

B-cell Lymphoma

IGH/BCL2

t(14;18)

Follicular/DLBC

API2/MALT1

t(11;18)

MALT Lymphoma

MALT1

18q21 rearrangements

MALT Lymphoma

TCRa/d

T-cell gene rearrangements

T-cell Neoplasms

6q21/6q23

6q deletion

Lymphoid Disorders

MYC

8q24 rearrangements

ALK

ALK rearrangement

Lung Cancer

FGFR1

FGFR1 amplification

Lung Cancer

HER2

HER2 amplification

Breast/Gastric/Esophageal Cancers

MET

MET amplification

Lung Cancer

RET

RET rearrangement

Lung Cancer

ROS1

ROS1 rearrangement

Lung Cancer

LIBRARIES AND CODES 7-7

©2012–2015 Genoptix, Inc. Genoptix®, COMPASS®, CHART® and NexCourse® are registered trademarks of Genoptix, Inc. cobas® is a registered trademark of Roche Diagnostics, NanoString®, Prosigna®, and nCounter® are registered trademarks of NanoString Technologies, AQUA® is a registered trademark of HistoRx, Inc., Vysis® is a registered trademark of Abbot Group. 100100 • January 2015

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