Cepheid, a leading molecular diagnostics company, announced an agreement with Henry Schein Medical, the US 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 US 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.
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.