Cepheid has announced an agreement with Medline 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.