SUNNYVALE, Calif., April 21, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced an agreement with Medline, the largest privately held distributor of healthcare products in the United States, for the distribution of the GeneXpert® System and menu of Xpert® tests spanning healthcare associated infections, critical infectious disease, and sexual health. Under the terms of the non-exclusive agreement, Medline will begin offering the GeneXpert System to non-acute care laboratory customers in the United States, including long-term care facilities with moderately complex labs, 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, and reference laboratories.
"The GeneXpert System is already the world's most widely used molecular diagnostics instrument, thanks to the system's accuracy, ease-of-use, flexibility, and broad menu of 20 tests available to our customers in the United States, primarily in the hospital market," said Peter Farrell, Cepheid's Executive Vice President, Worldwide Commercial Operations. "This new distribution agreement with Medline further extends our reach into laboratories and testing facilities outside the hospital, notably including some long-term care facilities, allowing these Medline customers to gain access to the same innovative molecular diagnostics technology that has, until now, been largely limited to hospital laboratory settings."
"The molecular diagnostics that Cepheid develops, manufactures and markets for testing provides our physician office customers with access to the most accurate, current, and fastest results on several infectious disease states to include MRSA, C. difficile, and chlamydia and gonorrhea," said Bob Ortiz, SVP of Medline's Physician Office Group. "Just a few years ago, the availability of hospital-quality molecular diagnostics that are easy-to-use in the physician office lab seemed out of reach. Now, we are pleased to be at the forefront of enabling healthcare accessibility, which we believe will bring patients closer than ever to impactful decisions about their individual diagnoses and treatments."
The distribution agreement with Medline is effective immediately, with an initial focus on the GeneXpert System and portfolio of moderately complex Xpert tests, and the Clinical Laboratory Improvement Amendments (CLIA)-waived version of Cepheid's Flu and RSV test, which was granted 510(k) clearance and CLIA waiver in December 2015. Subject to FDA review of the GeneXpert Omni System and associated tests, Medline will also distribute Cepheid's CLIA-waived products for the GeneXpert Omni when they become available.
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' 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 20 tests in the US. More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com.
Medline is a global manufacturer and distributor serving the health care industry with medical supplies and clinical solutions that help customers achieve both clinical and financial success. Headquartered in Mundelein, Ill., the company offers 350,000+ medical devices and support services through more than 1,200 direct sales representatives who are dedicated points of contact for customers across the continuum of care. For more information on Medline, go to www.medline.com or http://www.medline.com/social-media to connect with Medline on its social media channels.
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 benefits and terms of the distribution agreement with Medline and 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 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.
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA