Cepheid Announces European Release of Xpert Carba-R, a Molecular Test for Rapid and Accurate Detection of Carbapenemase-producing Gram-negative Bacteria

SUNNYVALE, Calif., June 16, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced the release of Xpert^® Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria, to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid's GeneXpert^® System, the world's leading molecular diagnostic platform. Xpert Carba-R detects and differentiates genes encoding the most prevalent carbapenemases — reporting five gene families that comprise 68 known individual resistance genes, including KPC, NDM, VIM, OXA-48 and IMP-1.

"Carbapenemase-producing organisms were named for their ability to fight off carbapenem antibiotics — the last line of defense in our medical toolbox," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Xpert Carba-R provides healthcare institutions a much-needed tool for rapid and accurate detection of patients colonized with these multidrug resistant organisms to help prevent widespread outbreaks and determine the best infection prevention pathways."

Carbapenemase-producing (resistant) organisms, or CROs, include the Enterobacteriaceae, which is a family of bacteria that normally live in the digestive system, including organisms such as Klebsiella pneumoniae and Escherichia coli. They are part of normal human gut bacteria. However, carbapenemase producers also include Pseudomonas aeruginosa, Acinetobacter baumannii, and a variety of other healthcare-associated pathogens that have become resistant to the antibiotics known as carbapenems. Carbapenems are often referred to as the antibiotics of last-resort and are usually reserved for severe life-threatening infections caused by multidrug resistant organisms. All of these organisms are capable of harboring and spreading these carbapenem resistance genes.

The emergence and global spread of carbapenemase-producing organisms is of great concern to health services worldwide. These bacteria are often resistant to all beta-lactam antibiotics and frequently co-resistant to most other antibiotics, leaving very few treatment options.

"Detection of patients carrying carbapenemase-producing microorganisms, with differentiation among the five major families of resistance genes, can significantly impact infection control. With results in less than an hour, we have the advantage of rapid implementation of epidemiological measures to control the spread of these microorganisms," said Dr. Rafael Canton, Professor of Microbiology at the Hospital Universitario Ramon y Cajal, Madrid, Spain.

Carbapenemases of global importance include Klebsiella pneumonia carbapenemase (KPC), New Delhi metallo-β-lactamase (NDM), Verona integron-encoded metallo-β-lactamase (VIM), imipenemase metallo-β-lactamase (IMP), and oxacillinase-48 (OXA-48). As of 2014, KPC is the most widespread carbapenemase in the United States¹ while OXA-48 is becoming the most important one in most European countries².

"Like our other GeneXpert cartridges, Xpert Carba-R can be performed on a STAT basis — no waiting for batched results. Rapid identification of colonized patients allows healthcare institutions to begin immediate implementation of infection control measures to prevent spread in highly susceptible populations," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Active screening of high risk patients has the additional benefit of allowing clinicians to optimize isolation decisions and avoid the impact of unnecessary isolations."

Healthy people rarely get CRO infections, which are usually healthcare-associated infections found in patients in hospitals, nursing homes, and other healthcare settings. Patients whose care requires devices like ventilators, urinary catheters, or intravenous catheters, and patients who are taking long courses of certain antibiotics are most at risk for CRO infections.³

Xpert Carba-R begins shipping this month as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.

About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: 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. Cepheid's newly announced Xpert MTB/RIF test can provide rapid information on the presence of TB and potential drug resistance within two hours, which distinguishes it from other available TB tests. For more information, visit http://www.cepheid.com.

References

1. http://www.cdc.gov/hai/organisms/cre/
2. http://www.ecdc.europa.eu/en/publications/Publications/antimicrobial-resistance-carbapenemase-producing-bacteria-europe.pdf
3. http://www.doh.wa.gov/Portals/1/Documents/5100/420-097-Guideline-CRE.pdf

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 performance, speed and accuracy of our products, including relative to competing products, the breadth and speed of test menu expansion, the results of clinical trials, and future medical practice dynamics, including the utilization of our tests in a clinical environment.  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 our tests by clinicians; our ability to successfully 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 clinical 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 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.

SOURCE Cepheid