Cepheid, Sunnyvale, Calif, has entered into an agreement with Henry Schein Medical, the US medical business unit of Henry Schein Inc, Melville, NY, for the distribution of Cepheid’s GeneXpert system and a menu of 17 Xpert tests spanning healthcare-associated infections, critical infectious diseases, and sexual health.
Under the nonexclusive 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 multispecialty clinics, urgent care facilities, community health centers, correctional facility laboratories, student health centers, sexually transmitted disease clinics, long-term care facilities, and reference laboratories.
According to Peter Farrell, executive vice president for global commercial operations at Cepheid, previous adoption of the GeneXpert system has been largely limited to US hospital laboratories. “We are pleased to extend the reach of the GeneXpert system to the non-acute care laboratory market through Henry Schein, which 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,” Farrell says.
“Cepheid’s Xpert test portfolio delivers high-quality molecular diagnostics in an easy-to-use format that is accessible to labs of all sizes,” says David Persing, MD, PhD, chief medical and technology officer at Cepheid. “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 a portfolio of 17 moderate complexity Xpert tests. Also included under the agreement will be the Xpert Flu/RSV test, which was recently granted FDA premarket notification (510(k)) clearance and, at the beginning of December 2015, received waived status under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
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.
For more information, visit Cepheid.