'Superbug' Test Updated to Identify Newest Carbapenem-Resistant Organisms

Xpert Carba-R Detects and Differentiates Most Prevalent CROs

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Jul 29, 2015, 07:03 ET

SUNNYVALE, Calif., July 29, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced the international availability of an update to Xpert® Carba-R, with the addition of two newly emerging carbapenemase genes, OXA-181 and OXA-232. The on-demand, molecular test also detects and differentiates among the five most prevalent mechanisms of carbapenem resistance, namely KPC, NDM, VIM, IMP-1 and OXA-48.

"Carbapenem-resistant organisms, commonly referred to as CROs or Superbugs, are a growing and expensive challenge for healthcare providers around the world," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Xpert Carba-R provides a much-needed tool for rapid and accurate detection of patients potentially colonized with these multidrug resistant organisms, and could help prevent or control outbreaks and determine the best infection prevention pathways."

"Xpert Carba-R cartridge now detects 91 resistance genes distributed among 5 distinct gene families, many of which are extremely difficult to detect by using conventional laboratory procedures, in less than an hour," added David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Rapid detection of these organisms in surveillance swabs allows health care providers to make infection control decisions quickly and avoid the inconvenience and expense of placing patients in isolation rooms unnecessarily."

"Rapid detection of carbapenemase-producing organisms using the GeneXpert system is a crucial part of our infection control program," noted Dr. Edoardo Carretto, Director of the Clinical Microbiology Laboratory at IRCCS - Arcispedale Santa Maria Nuova, in Reggio Emilia, Italy. "The instrument is easy to use and the Xpert Carba-R assay, which now includes detection of OXA-48, OXA181, and OXA232, in addition to KPCs, VIMs, IMPs, and NDMs, takes less than one hour to complete. This short turn-around-time is critical for infection control decisions, especially at the admission time of patients who may be at high risk for colonization."

The updated Xpert Carba-R is now shipping 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 GeneXpert Systems and Xpert Tests
With more than 8,900 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 17 tests in the US. More information on the GeneXpert system and the Xpert tests is available on our website at www.cepheid.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. For more information, visit www.cepheid.com.

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 availability, performance, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of our products, including relative to competing products and technologies, the availability and performance of products currently under development, future medical practice dynamics, including the utilization of our tests in a clinical environment, and the ability of our products to help reduce prevalence of disease and cut future medical treatment costs. 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 and future changes in medical practice and protocols; our 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.

SOURCE Cepheid