MDRO Gene Test

Accurate MDRO Gene Detection DIRECT

SENSITIVE

COMPREHENSIVE

The MDRO Threat is a Worldwide Problem 1 In the US, at least 2 million people acquire serious antibiotic resistant, bacterial infections each year 1 • 23,000 die • These Hospital Acquired Infections (HAIs) cost the US $35 billion each year • The pipeline for future antibiotics is limited

ESTIMATED ANNUAL NUMBER OF CASES

ESTIMATED ANNUAL NUMBER OF DEATHS

CDC THREAT LEVEL

CRE

9,300

610

URGENT

Multi-Drug Resistant Acinetobacter

7,300

500

SERIOUS

ESBLs

26,000

1,700

SERIOUS

VRE

20,000

1,300

SERIOUS

6,700

440

SERIOUS

MULTI-DRUG RESISTANT ORGANISMS ¹

Multi-Drug Resistant Pseudomonas aeruginosa

• CRE now reported in 47 states 2 • The number of acute care hospitals reporting at least 1 CRE infection increased 4-fold in one decade 3 • 18% of long term care facilities have reported CRE presence 3

Intervene at First Recognition of MDRO 4 -Centers for Disease Control and Prevention

Studies Report: • Higher colonization rates result in higher transmission rates 5 • 7.4% of CRE colonized patients become infected 6

The Acuitas™ MDRO Gene Test directly detects 7 critical MDRO genes with high sensitivity from one swab • Identifies patients at risk for being colonized

Detecting Colonization Early May:

• Screens for genes associated with CRE, ESBL, and VRE

• Improve Antibiotic Stewardship Programs

• Accurate, fast, molecular technology

• Provide early warning for infection control and prevention programs • Improve patient outcomes and reduce length of stay

Molecular Technologies Detect MDRO Threats Faster, Should be Used More Widely 1 -Centers for Disease Control and Prevention

Molecular Methods are Faster and Detect 20% more At Risk Patients than Culture 7, 8, 9, 10 Acuitas MDRO Gene Test • Quickly detects genes associated with CRE, CTX-M related ESBLs, and VRE • Broad subtype coverage • Differentiates OXA-48, OXA-23, and OXA 51 • Direct from Peri-anal swab* Acuitas Elite MDRO Test • Combines gene test with follow-up microbiological analysis • Specimens positive for genes are automatically reflexed to culture analysis to identify organism and determine antibiotic susceptibility * Validated for use with Eswabs™. Culture isolates also validated. Rectal, stool, throat, and other sample types are in development.

Comprehensive MDRO Genes per Swab

Analytical Sensitivity Acuitas

Analytical Specificity

MDRO Genes

Organism

LOD (CFU/mL)††

Acuitas

MDRO Gene Presence†††

MDRO Gene Absence†††

KPC



KPC

E. cloacae

84

+

100

0

NDM



NDM

K. pneumoniae

93

-

0

143

VIM



VIM

37-154

IMP



S. marcescens, P. aeruginosa, E. cloacae

OXA-48



IMP

K. pneumoniae

13-66

OXA-23



OXA-48

K. pneumoniae

79

OXA-51 †



OXA-23

A. baumannii

109

ESBL Associated

OXA-51

A. baumannii

125

CTX-M



CTX-M

K. pneumoniae

79-151

VRE Associated

VanA



E. faecium

250

CRE Associated

Carbapenemase Producer Associated

VanA

Results from CLIA validation performed at OpGen® Clinical Services Laboratory. † OXA 51 presence may or may not confer to carbapenem resistance. †† LOD determined in serial dilution studies with negative peri-anal swabs spiked with an organism containing the target. ††† Determined against 100 clinical isolates with known MDRO genes and 143 without MDRO genes that are detected by the Acuitas MDRO Gene Test.

Studies Indicate That Early Detection May Improve Outcomes and Reduce Costs Patients At Risk The following patients are considered to be at especially high risk of contracting an MDRO infection: 1, 11 • Cancer chemotherapy • Complex surgery • Dialysis for end stage renal disease • Organ and bone marrow transplants • Suffering from rheumatoid arthritis • Patients hospitalized within the last 6 months in countries outside of the United States

Screening and Surveillance • The CDC recognize screening for patients at risk as a prevention strategy 4 • Surveillance can detect the presence of CRE 9 days before it is apparent in clinical cultures 12 • Active surveillance for CRE reduced the incidence of infection by 4 to 30-fold 6, 13

Health Economics • CRE infected patients stayed in the hospital 20 days longer than control patients 6, 13 • Screening asymptomatic patients for CRE decreased length of stay 12 • CMS provides incentives for HAI prevention 14

The OpGen® Clinical Services Laboratory utilizes advanced molecular technologies for analysis of pathogens responsible for hospital acquired infections Providing Complete Microbial Genetic Analysis • Acuitas MDRO Gene Test • Acuitas Elite MDRO Test • C. difficile DNA Complete Test • MRSA DNA Screening Test • C. difficile MLST Analysis • Next Generation Sequencing Analysis (in development)

References 1

Antibiotic Resistant Threats in the United States. CDC.gov

2 CDC.gov 3

CDC Vitalsigns. March, 2013. CDC.gov

4

Guidance for Control of Carbapenem-resistant Enterobacteriaceae (CRE). 2012 CRE Toolkit. CDC.gov

5

Popoola et al. Impact of colonization pressure and strain type on methicillin-resistant Staphylococcus aureus transmission in children. CID. 2013:15 (November 15).

6

Borer et al. A multifaceted intervention strategy for eradication of a hospital-wide outbreak caused by carbapenem-resistant Klebsiella pneumonia in southern Israel. ICHE. 2011:32(12).

7

Savard et al. The challenges of carbapenemase-producing enterobacteriaceae and infection prevention: protecting patients in the chaos. ICHE. 2013:34(7).

8

Schechner et al. Evaluation of PCR-based testing for surveillance of KPC-producing carbapenem-resistant members of the Enterobacteriaceae family. JCM. 2009:47(10).

9

Singh et al. Rectal screening for Klebsiella pneumoniae carbapenemases: comparison of real-time PCR and culture using two selective screening agar plates. JCM. 2012:50(8).

10 Vasoo. et al. Rapid and direct real-time detection of blaKPC and blaNDM from surveillance samples. JCM. 2013:51(11). 11 Health Alert Network Advisory, Feb. 14, 2013. CDC.gov. 12 Calfee et al. Use of active surveillance cultures to detect asymptomatic colonization with carbapenem-resistant Klebsiella pneumoniae in intensive care unit patients. ICHE. 2008:29(10). 13 Ben-David et al. Potential role of active surveillance in the control of a hospital-wide outbreak of a carbapenem-resistant Klebsiella pneumoniae infection. ICHE. 2010:31(6). 14 Fact Sheet: CMS Final rule to improve quality of care during hospital impatient stays. 2013. CMS.gov.

US Toll Free: 1.888.856.2748 - [email protected] - OpGen.com ©2014 OpGen, Inc. OpGen , and Acuitas™ are trademarks of OpGen, Inc. in the US and/or certain other countries. All other trademarks and/or service marks not owned by OpGen, Inc. that appear in this document are the property of their respective owners. ®

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