Cepheid Receives FDA CLIA Waiver for Xpert Flu+RSV Xpress Test

SUNNYVALE, Calif., Dec. 7, 2015 /PRNewswire/ -- Cepheid CPHD today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Flu+RSV Xpress test for use on the GeneXpert® Xpress™ System.  The GeneXpert Xpress System is a customized GeneXpert System comprised of a single module and a tablet computer with an ATM-like interface specifically for the CLIA waived environment.  Xpert Flu+RSV Xpress is the first PCR panel test to achieve CLIA waiver, and the first in a series of reference-quality molecular tests that Cepheid intends to deliver to the point of care market over the next several years.

"There are more than 1 billionⁱ visits annually to physicians' offices in the United States and yet, until recently, CLIA waived testing sites have not had access to the same levels of accuracy found in sophisticated hospital or reference laboratories," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "We believe that point of care testing will be well served by the significant step up in accuracy and multiplexing capability of PCR-based molecular assays and are committed to broadening access to these important tests."

"The Flu+RSV Xpress test uses the same design as our lab-based Flu/RSV XC test, which has already shown in several studies^ii,iii to provide performance that meets or exceeds that of other conventional molecular testing run in hospital or reference labs," added David Persing, M.D., Ph.D, Cepheid's Chief Medical and Technology Officer.  "Novel design features of this test include high-level multiplexing, redundant target segments, and extended coverage for human and avian influenza strains - a first in the industry for the CLIA waived market and an important step towards pandemic preparedness."

Cepheid's Xpert Flu/RSV XC test has been available for CLIA moderate complexity customers since November 2014.  The Xpert Flu+RSV Xpress test utilizes the same test cartridge as the Xpert Flu/RSV XC test and will be available for customers in CLIA-waived settings in December.  Both Cepheid's Xpert Flu/RSV XC and Xpert Flu+RSV Xpress tests detect and differentiate between Influenza A, Influenza B, and RSV, in about one hour.

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 9,200 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 molecular diagnostics' system 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 18 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, 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; market acceptance of new products and acceptance of our products in new markets; sufficient customer demand, customer confidence in product availability and available customer budgets for Cepheid's customers; 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; Cepheid's ability to successfully introduce and sell products in global markets; Cepheid's research and development budget; unforeseen supply, development and manufacturing problems; Cepheid's ability to manage its inventory levels; Cepheid's ability to successfully complete and bring on additional manufacturing lines; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; Cepheid's reliance on distributors in some regions to market, sell and support its products; the impact of competitive products and pricing; the costs of product components and other factors affecting product pricing; Cepheid'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.

ⁱ National Ambulatory Medical Care Survey: 2010 Summary Tables http://www.cdc.gov/nchs/fastats/physician-visits.htm  
ⁱⁱ Popowitch EB, Miller MB.  Performance Characteristics of Xpert Flu/RSV XC Assay.  Journal of Clinical Microbiology 2015 Aug; 53(8):2720-1. 
ⁱⁱⁱ Salez, N, Nougairede, A, Ninove, L, Zandotti ,C, de Lamballerie,X, and Charrel ,RN.  Prospective and retrospective evaluation of the Cepheid Xpert® Flu/RSV XC assay for rapid detection of influenza A, influenza B, and respiratory syncytial virus.  Diagnostic Microbiology and Infectious Diseases. 2015 Apr;81(4):256-8.

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

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SOURCE Cepheid