Cepheid has received clearance from the FDA to market its Xpert® Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. Xpert Flu/RSV XC runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 7,500 systems installed worldwide.

"Influenza strains are notoriously unpredictable and the severity of flu outbreaks can vary widely from season to season," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Recent media coverage of serious viruses such as Enterovirus D68 and Ebola have raised public awareness, and created a greater need for healthcare workers to deliver timely and accurate test results for flu or RSV infection."

Doctors Donna M. Wolk and Raquel M. Martinez, investigators at Geisinger Health System, were involved in investigational testing of Xpert Flu/RSV XC during Cepheid's product development phase. Their Microbiology Research team is planning a pilot testing program they call FluWorks©. This program aims to allow test results to be immediately delivered to physicians and patients or designated family members via electronic health records, web portal, or text messaging.

"We are anxious to understand the role that the Xpert Flu/RSV XC test can play in Geisinger's FluWorks program, designed to improve patient care, clinical operations, and laboratory stewardship. Rigorous investigational testing documented the assay's high accuracy and speed," said Dr. Wolk. "This winter, we plan to leverage the test's unique design to quickly test patients presenting with influenza-like illness at Emergency Departments, out-patient clinics, and in selected Urgent Care Clinics."

The severity of a flu outbreak can vary greatly from one season to the next depending on which flu viruses are spreading, how many people get vaccinated, and how well the flu vaccine is matched to the flu viruses that are currently causing illness.

"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for fast and accurate detection and differentiation of Flu A, Flu B, and RSV infection," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "This test may also become a valuable asset in efforts toward pandemic preparedness, because it was designed from its inception to provide unprecedented coverage of both human and avian influenza strains."

Xpert Flu/RSV XC begins shipping in early December. For more information on Cepheid's GeneXpert Systems or a complete menu of tests, visit www.cepheid.com.