Managed Care Partnership Value

Ambry is a genetics-based healthcare company that is dedicated to open scientific exchange so we can work together to understand and treat all human disease faster. The Value of Partnering with Ambry Ambry is your managed care partner. Our goal is to provide healthcare providers cost-effective, clinically relevant testing solutions for the patients and families they serve. The following are some of the benefits of partnering with us.

a diverse menu We offer over 600 genetic tests that suit many medical specialties, and our complete test menu can be found at ambrygen.com/tests. Highlights include: • Cancer: BRCA1/2 and Lynch syndrome • Pulmonology: CFTR sequencing for cystic fibrosis • Cardiology: Inherited cardiomyopathies and arrhythmias (like long QT syndrome) • Neurology: Epilepsy, neurodevelopmental and neurocutaneous disorders • Pediatrics: Clinical exome sequencing and many tests for general genetics

reducing unnecessary testing and cost Our Board-certified genetic counselors review every test ordered

options Genetic testing can be ordered to meet clinical need (sequentially, concurrently, multi-gene tests for overlapping phenotypes)

unparalleled service Our genetic counselors, geneticists, and scientists support healthcare providers throughout the testing process

ease and efficiency Healthcare providers have secure access to AmbryPort2.0 (AP2), Ambry’s electronic ordering/tracking/resulting portal. ambrygen.com/ap2

ongoing education We offer webinars and other education for healthcare providers on benefits and clinical utility of genetic testing. ambrygen.com/webinars

research to improve patient care We are committed to securely sharing data and promoting scientific discoveries through presentations at national meetings, and peer-reviewed publications. ambrygen.com/research-and-collaborations

About Ambry

First to commercially offer CTFR gene sequencing for cystic fibrosis

First to offer clinical whole exome sequencing

Amongst the first to offer clinical next generation sequencing with an 81-gene test for X-linked intellectual disability

First to offer BRCA1/2 testing after June 2013 Supreme Court ruling on gene patents

First to commercially offer multi-gene tests for hereditary cancer

Offered new approach to testing for epilepsy

Offered new approach to testing for hypertrophic cardiomyopathy, long QT syndrome, Brugada syndrome

Providing outstanding service and support are top priorities at Ambry. We strive to simplify the test ordering process by: • Accepting multiple validated sample types, including saliva • Preverifying insurance benefits within 72 hours to clarify any patient out-of-pocket expenses • Having Board-certified genetic counselors and medical directors readily available to assist in test selection, case reviews, and result interpretation

Mauli Ola Foundation Ambry leadership created the Mauli Ola Foundation (MOF) in 2005 to promote awareness of genetic diseases. MOF raises funds to support programs for those with life-threatening illnesses and provide direct, immediate ways for children with genetic disorders to enjoy healthy lives through natural treatments. Cystic fibrosis (CF) is a hereditary genetic condition that affects more than 30,000 in the U.S. Those with CF have chronic lung problems and digestive disorders, often resulting in frequent hospitalizations. MOF Surf Experience and Ocean Experience Days get kids with CF into the ocean (high in saline) to experience what natural therapies can do for their lungs. The saline breaks down lung congestion and is a healthy, fun alternative to the typical regimens for CF.

about us

Founded in 1999 by CEO Charles Dunlop, we have consistently been at the forefront of applying new technologies to clinical molecular diagnostics. Known initially for being the first commercial laboratory to offer complete sequence analysis of the CFTR gene, over the years we have spearheaded the development and application of new genetic solutions for the advancement of diagnosis and disease research. Some of this history includes:

Testing Services Overview

testing

Ambry offers a full menu of diagnostic solutions for multiple clinicians including geneticists, oncologists, cardiologists, pulmonologists, neurologists, gastroenterologists, and many others. Our current menu includes over 600 genetic diagnostic tests, like CancerNext-Expanded, which analyzes 49 clinically relevant hereditary cancer genes, ExomeNext/ExomeNext-Rapid, which sequence and analyze ~20,000 clinically relevant genes in the exome and mitochondrial genome in as quickly as 2-5 weeks (for Rapid), and CardioNext, which analyzes 84 genes clinically relevant in cardiovascular disorders.

Tests Menu Highlights

multiple congenital anomalies • CHARGE syndrome • Noonan syndrome

cancer • Hereditary breast ovarian cancer • Lynch syndrome • PALB2, APC, MUTYH

gastroenterology • Pancreatitis • RET-related Hirschsprung disease • Peutz-Jeghers syndrome

pulmonology

• Juvenile polyposis

• Cystic fibrosis • Surfactant dysfunction • Congenital central hypoventilation syndrome

future genes • By request to suit clinical need

ambry genetics endocrine/ metabolism

• Maturity-Onset Diabetes of the Young • Smith-Lemli-Opitz syndrome

epilepsy • Epileptic encephalopathies • Focal epilepsies • Progressive myoclonus epilepsy

neurodevelopment clinical genomics

• Chromosomal microarrays (SNP+CGH, 180K oligo options) • E xomeNext/ExomeNext-Rapid

cardiology

• Fragile X syndrome • Rett syndrome • PTEN-related disorders • X-linked intellectual disability

• Long QT syndrome/inherited arrhythmias • Inherited cardiomyopathies

hematology/pediatric oncology

• Marfan syndrome and related disorders

• Diamond-Blackfan anemia

• Thoracic aortic aneurysms

• Beta-thalassemia/Sickle-cell disease • Hereditary hemorrhagic telangiectasia

Sample Types Accepted • Blood • Saliva • DNA • Blood spots • Cultured cells (amniocytes, CVS, fibroblasts) Sample types accepted may vary by test ordered.

Common CPT/Mopath Codes Billed by Ambry Genetics 81294

81404

81212

81295

81405

81213

81298

81406

81223

81317

81407

81280

81319

81408

81292

81321

81479

81293

81403

Customer Service Our clinical and client services teams are available to assist providers and patients throughout the entire testing process, including: • Order processing • Benefits eligibility and verification • Prior authorization • Reimbursement questions • Understanding which test to order, and understanding test result reports • Test ordering, test status tracking, and results reporting via HIPAA-compliant, secure online AmbryPort2.0 portal Ambry’s team of Board-certified medical directors and genetic counselors is available to provide support Monday to Friday from 8:00 a.m. ET to 8:00 p.m. ET. We also have dedicated teams available to help ordering providers and patients with benefit eligibility verification, test authorization, and questions regarding billing and reimbursement. Our goal is to make the genetic testing process simple and easy, from ordering to the result report. We remain available along the entire pathway to answer any questions.

testing

81211

Benefits of Multi-Gene Cancer Tests Using Next Generation Sequencing summary of experience Ambry has offered commercial single gene testing for multiple hereditary cancer syndromes since 2003. We introduced multi-gene tests for hereditary cancer syndromes in early 2012, and have amassed tremendous clinical data, growth, and experience with these tests since then.

expertise

A 2015 study with our collaborators retrospectively compared nearly 1,000 patients who underwent BRCA1/2 limited testing or relevant multi-gene panel testing. An additional 3.9% of patients in the panel group were found to have cancer risk related to mutations in non-BRCA genes – doubling the diagnostic mutation rate in the panel group.1 We have reported over 100,000 multi-gene cancer test results and have published data demonstrating the yield of testing using this approach. 2 When added to the 10% positive rate for BRCA1/2 single gene testing (reported by Informed DNA for patients who met criteria for BRCA1/2 testing), use of multi-gene cancer tests nearly doubles the amount of patients found with hereditary cancer risk. These patients may benefit from increased screening and prevention measures reducing their overall lifetime risk to develop cancer.

Client Base In USA Since 1999, Ambry Genetics has been serving the molecular diagnostic testing needs of hospitals, reference labs, and specialty clinicians in North America and across the world. Our client base includes the following centers of excellence in the U.S.: • Arkansas Children’s Hospital • Dana-Farber Cancer Institute • Kaiser Permanente • Nationwide Children’s Hospital • Rocky Mountain Cancer Centers • Southwestern Medical Center • UCLA Health System • UCSF Medical Center • University of Miami Health System 1. Kapoor NS, et al. Multigene panel testing detects equal rates of pathogenic BRCA1/2 mutations and has a higher diagnostic yield compared to limited BRCA1/2 analysis alone in patients at risk for hereditary breast cancer. Ann Surg Oncol. 2015 Oct;22(10):3282-8. 2. LaDuca H et al. Utilization of multigene panels in hereditary cancer predisposition testing: analysis of more than 2,000 patients. Genetics in Medicine. 2014 Nov;16(11):830-7.

Clinical Expertise scientific and clinical expertise We are committed to providing world-class genetic testing services. We have a dedicated team of scientists spearheading the development and application of new genetic technologies for the advancement of diagnosis and disease research. Our highly experienced clinical team of Boardcertified medical directors, medical geneticists, and over seventy genetic counselors works together to help clinicians provide appropriate testing and accurate results interpretation for each patient. We also have a specialized team to analyze and classify genetic variants that may arise from testing. As a CAP-accredited and CLIA-certified laboratory, we are a trusted resource for clinicians. Additionally, we have our own in-house medical technologist training program. Our clinical leadership includes the following nationally recognized physicians and pathologists: Aaron Elliott, PhD Chief Operations Officer; Interim Chief Scientific Officer

Sha Tang, PhD, DABMG Laboratory Technical Director, Clinical Genomics

Sharon Mexal, PhD Director of Clinical Operations

Chia-Ling Gau, PhD, DABMG Senior Laboratory Technical Director

Trieu Timothy D. Vo, PhD, DABMG, FACMG Laboratory Director

Phillip Gray, PhD Director of Assay Development

Michael Jarvis, PhD Assistant Laboratory Technical Director

Brigette Tippin Davis, PhD Laboratory Technical Director

Nambi Ramalingam, PhD Assistant Laboratory Technical Director

Ruth Baxter, PhD Assistant Laboratory Technical Director

Wendy Alcaraz, PhD Assistant Laboratory Technical Director

Melissa Pronold, PhD Assistant Laboratory Technical Director

J. James Song, PhD Associate Laboratory Technical Director

Tax ID

33-0892453

California

CLF00011694

NPI

1861568784

Florida

800016789

CLIA

05D0981414

Maryland

1052

CAP

7154701

New York

8160

05D0981414

Rhode Island

LCO00680

Medicare

expertise

LICENSURE AND CREDENTIALS

for more information, please contact: Ambry Genetics 15 Argonaut Aliso Viejo, CA 92656 USA ambrygen.com Direct +1 949-900-5500 Fax +1 949-900-5501 [email protected]

15 Argonaut, Aliso Viejo, CA 92656 USA

Toll Free +1 866 262 7943

Fax +1 949 900 5501

50339.1551_v4 MCINFOBRO