SUNNYVALE, Calif., Jan. 4, 2016 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced an agreement with Henry Schein Medical, the U.S. Medical business of Henry Schein, Inc., for the distribution of its GeneXpert® System and menu of 17 Xpert® tests spanning healthcare associated infections, critical infectious disease, and sexual health.
Under the new, non-exclusive agreement, Henry Schein will offer the GeneXpert System to its non-acute care laboratory customers in the United States, including physician-office laboratories, women's health and large multi-specialty clinics, urgent care facilities, community health centers, correctional facility laboratories, student health centers, STD clinics, long-term care facilities and reference laboratories.
"Until now, the GeneXpert System has been largely limited to U.S. hospital laboratories where its ease-of-use, flexibility, and broad test menu have already made it the most prevalent molecular diagnostics system in use today," said Peter Farrell, Cepheid's Executive Vice President of Global Commercial Operations. "We are pleased to extend the reach of the GeneXpert System to the non-acute care laboratory market through Henry Schein, who is deeply committed to bringing the latest innovations in products and services to its customers for the benefit of their practice and laboratory and the patients they care for."
"Cepheid's Xpert test portfolio delivers high quality molecular diagnostics in an easy-to-use format that is accessible to labs of all sizes," said David Persing, M.D., Ph.D, Cepheid's Chief Medical and Technology Officer. "Our relationship with Henry Schein opens an immediate opportunity for GeneXpert System placements in more than 10,000 moderately complex labs outside the hospital, and – once we bring the GeneXpert Omni to market in about a year – we expect Henry Schein to help further extend that reach into more than 100,000 CLIA Waived Physician Office Laboratories to benefit from the efficiencies and improved patient outcomes associated with rapid, high quality molecular test results."
The distribution agreement with Henry Schein is effective immediately, with an initial focus on the GeneXpert System and portfolio of 17 moderately complex Xpert tests, and the Clinical Laboratory Improvement Amendments (CLIA)-waived version of Xpert Flu/RSV which was granted 510(k) clearance and a CLIA waiver earlier this month. Subject to FDA review of the GeneXpert Omni System and associated tests, Henry Schein will also distribute Cepheid's CLIA-waived products for the GeneXpert Omni when they become available in late 2016.
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 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 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 19 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, scale and sustainability of future growth, future regulatory approvals and product releases and the breadth and speed of market segment expansion. 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; the 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.
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
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