Cepheid announced an agreement with Henry Schein Medical, the US medical business of Henry Schein, 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.
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.