Medline has entered an agreement to distribute the GeneXpert system and menu of Xpert tests from Cepheid, Sunnyvale, Calif, to non-acute care laboratory customers in the United States. The market includes long-term care facilities with moderately complex labs, 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, and reference laboratories.

“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,” says Peter Farrell, executive vice president of worldwide commercial operations at Cepheid.

Offering the ability to perform from one to 80 Xpert tests at the same time, the GeneXpert system is suited for customers of all sizes, from lower volume point-of-care settings to higher volume reference laboratories. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious diseases, and oncology, and today offers 23 tests outside the United States, and 20 tests in the United States.

“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,” says Bob Ortiz, senior vice president of the physician office group at Medline. “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 respiratory syncytial virus test, which was granted FDA premarket notification (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.

For more information, visit Cepheid or Medline.