World's First "Go-Anywhere" Molecular Diagnostic System Unveiled at AACC

GeneXpert Omni Sets New Standard for Molecular Point of Care Testing

Jul 28, 2015, 07:05 ET from Cepheid

SUNNYVALE, Calif., July 28, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today unveiled the GeneXpert® Omni, a flexible and portable clinical molecular diagnostic system designed to meet the needs of the Point of Care market.  At just 9 inches tall, and weighing just 2.2 pounds, the GeneXpert Omni will run the same high quality PCR-based Xpert® cartridges as Cepheid's existing family of GeneXpert Systems, enabling highly accurate clinical molecular diagnostic tests to be performed in any near-patient testing environment, including CLIA-waived physician offices, clinics and specialty settings.

"Building on the accuracy, speed and ease-of-use that users expect from Cepheid's GeneXpert Systems, the GeneXpert Omni offers an even more streamlined user experience, with an advanced user interface that runs on a portable tablet or smartphone," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "The GeneXpert Omni is also wireless and web-enabled, setting a new standard in connectivity to transmit instrument and test information in real-time, supporting our customers' goals to cost-effectively improve clinical outcomes and increase patient satisfaction."

"Recognizing the need for faster test results in the Point of Care environment, Cepheid expects to launch even faster Xpert tests in conjunction with the availability of the GeneXpert Omni," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "Compared to an average run-time of about an hour today, we are further optimizing every stage within the cartridge with a goal of delivering test results in as little as 15 minutes, starting with our Xpert Xpress Group A Strep assay."

The GeneXpert Omni is on display at the American Association of Clinical Chemistry (AACC) meeting in Atlanta, Georgia, Booth 2811, from July 28-30, 2015.  The system is expected to be available for commercial Point of Care customers in late 2016.  The first test for the GeneXpert Omni is expected to be Xpert Flu/RSV.

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 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

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 Omni 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 Cepheid'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.

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

Photo - http://photos.prnewswire.com/prnh/20150727/245966

 

SOURCE Cepheid



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