Cepheid Announces First FDA-Cleared Test for Detection of Carbapenem Resistance Genes in Isolates of Multidrug Resistant 'Superbugs'

SUNNYVALE, Calif., March 9, 2016 /PRNewswire/ -- Cepheid CPHD today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Carba-R, a qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of 5 distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP.  Xpert Carba-R is the first FDA-cleared test for detection and differentiation of carbapenemase genes in pure bacterial isolates, previously shown to be non-susceptible to carbapenem antibiotics, which may be cultured from a wide range of clinical specimens, including blood cultures, urine, respiratory samples, abscesses and swab surveillance specimens. 

"The emergence of carbapenemase producing organisms, known as CPOs, represents a significant global healthcare risk since these bacteria are resistant to many of the beta-lactam antibiotics used for empiric therapy for gram negative infections.  These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "Carbapenem resistance mechanisms can be extremely difficult to characterize with conventional laboratory procedures.  Now, with a bacterial isolate and less than a minute of hands-on time, Xpert Carba-R delivers a result in under an hour, allowing timely detection and differentiation of the most prevalent carbapenemase genes associated with CPO outbreaks to support infection control efforts."

"The availability of a rapid and accurate molecular test for the most prevalent mechanisms of carbapenem resistance represents an important addition to the limited tools the laboratory has available to fight the emergence of multidrug resistant organisms, like CPOs," said Paul Schreckenberger, Ph.D., Director of Microbiology at Loyola University Medical Center.  "Knowing which carbapenemase gene is present in a resistant isolate helps the hospital identify and manage outbreaks and can also be valuable for monitoring the spread of multi-resistant bacteria among hospital populations considered most at risk."  

Xpert Carba-R will begin shipping in the United States later this month, and is the 20^th US-IVD test available to run on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 10,000 systems installed globally.  Xpert Carba-R is the latest diagnostic solution from Cepheid to help infection control professionals fight antimicrobial resistance, building on a portfolio that already includes MRSA, C. difficile and VRE.  The product's availability in the United States is particularly timely, following publication of a study last week from the Centers for Disease Control and Prevention citing carbapenem-resistant Enterobacteriaceae as an urgent threat and emphasizing the prevention of antibiotic-resistant healthcare-acquired infections as an important strategy for reducing the impact of antibiotic-resistant bacteria on human health, including the prevention of sepsis and death¹.

For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com.  

About Cepheid

Based in Sunnyvale, Calif., Cepheid CPHD is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.

About GeneXpert Systems and Xpert Tests

With more than 10,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' instrument.  The GeneXpert System's modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time.  As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.

GeneXpert Systems run proprietary Xpert test cartridges.  The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 23 tests outside the US, and 20 tests in the US.  More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com. 

Forward Looking Statements

This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to the future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert System and Xpert tests, including relative to competing products and technologies.  Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: test performance in the field; utilization of the Company's tests by clinicians and future changes in medical practice and protocols; the Company's ability to successfully and timely develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA, European and other regulatory processes; the Company's ability to successfully introduce and sell products in global markets; the Company's research and development budget; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the costs of product components and other factors affecting product pricing; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.

¹ Weiner LM, Fridkin SK, Aponte-Torres Z, et al. Vital Signs: Preventing Antibiotic-Resistant Infections in Hospitals — United States, 2014. MMWR Morb Mortal Wkly Rep. ePub: 3 March 2016. DOI: http://dx.doi.org/10.15585/mmwr.mm6509e1er.

For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com

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SOURCE Cepheid