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FDA Supports Expanded Claims for Xpert Carba-R Test for "Superbugs"

Thursday, June 30, 2016 General News J E 4
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Xpert Carba-R Test is the First FDA-Cleared Molecular Test for Rapid Detection of Carbapenemase Producing Organisms Directly from Rectal Swab Specimens

SUNNYVALE, Calif., June 30, 2016 /PRNewswire/-- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, the first FDA-cleared test for detection of carbapenem resistance genes of multidrug resistant 'superbugs'.  Following initial clearance in March for detection and differentiation of carbapenemase genes in pure bacterial isolates, the latest clearance extends use of the assay to the analysis of direct rectal swab specimens, and positions Xpert Carba-R as a valuable tool for the identification of colonized patients and as an aid to infection control efforts, both of which Cepheid believes are needed to escalate the fight against antimicrobial resistance.

"The number of global incidents associated with these deadly bacteria is surging, and is frequently associated with high morbidity and mortality, in addition to increased hospital costs1," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert Carba-R delivers a highly accurate result in as little as 48 minutes, enabling clinicians to assess high-risk patients for colonization status at or prior to admission, to enact full preventative measures as necessary to reduce the risk to the patient, the broader patient population, and hospital staff.  In contrast, traditional enriched culture methods typically take 3-5 days."

The CDC recommends comprehensive infection control measures for patients who are colonized or infected with carbapenemase-producing organisms2, known as CPOs or 'superbugs'.  CPOs are often resistant to many of the beta-lactam antibiotics used for empiric therapy for gram-negative infections, in addition to other classes of antibiotics. 

"Surveillance is a key infection prevention activity for monitoring and controlling the spread of CPOs in hospitals and long term care facilities," said Lance Peterson, M.D., Director of Microbiology and Infectious Diseases Research, NorthShore University Health System.  "Xpert Carba-R is the first real time PCR test for CPOs in the United States that can be performed on demand, thus facilitating surveillance studies."

Xpert Carba-R adds to the portfolio of Xpert tests offered by Cepheid to help infection control professionals fight antimicrobial resistance including MRSA, C. difficile, VRE, and MTB-RIF.  Xpert Carba-R runs on Cepheid's GeneXpert System, the world's leading molecular diagnostic platform with more than 10,000 systems installed globally.  Xpert Carba-R with the extended claim will begin shipping in July.

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. 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' system.  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 United States, and 20 tests in the United States.  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, product shipment timing, 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, and the impact of the Xpert Carba-R test in CPO infection surveillance, assessment of patients, prevention and control and in preventing antimicrobial resistance.  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 Clinical and economic impact of meropenem resistance in Pseudomonas aeruginosa–infected patients.  Judd, W.R. et. al, American Journal of Infection Control, June 16, 2016 (http://www.sciencedirect.com/science/article/pii/S0196655316303431)2 http://www.cdc.gov/hai/pdfs/cre/CRE-guidance-508.pdf

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

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-supports-expanded-claims-for-xpert-carba-r-test-for-superbugs-300292531.html

SOURCE Cepheid

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