Cepheid nabs FDA OK for point-of-care flu test

GeneXpert Omni--Courtesy of Cepheid

Just in time for peak flu season, Cepheid ($CPHD) got an FDA nod for its rapid influenza and RSV test for doctors' offices, giving the company some added momentum as it prepares to launch its point-of-care molecular diagnostic device.

The Sunnyvale, CA-based company snagged an FDA OK and CLIA waiver for its Xpert Flu+RSV Xpress test, which runs on the Cepheid's GeneXpert Express tablet system and screens for Influenza A, Influenza B and RSV in about one hour. The test builds on the company's lab-based Flu/RSV XC diagnostic and is the first of a series of molecular tests that Cepheid plans on bringing to the point-of-care market over the next several years, the company said in a statement.

There are about 1 billion visits each year to doctors' offices in the U.S. but until recently, CLIA waived testing sites haven't been able to access certain diagnostics found in hospitals or reference labs, Cepheid CEO John Bishop said in a statement. "We believe that point of care testing will be well served by the significant step up in accuracy and multiplexing capability of PCR-based molecular assays and are committed to broadening access to these important tests," Bishop said.

The regulatory blessing comes as Cepheid plans to roll out its point-of-care diagnostic system, GeneXpert Omni. The company said earlier this year that it would launch the device outside the U.S. during the first half of 2016 and in the U.S. for commercial customers in late 2016, providing testing for a wide range of applications including infectious disease, sexual health and oncology.

GeneXpert Omni could offer an advantage over other molecular diagnostics systems, as it allows clinicians to run up to 80 of Cepheid's tests at once, cutting down on time and improving scalability. If all goes to plan, the company will offer versions of its system for its entire test menu, which includes 23 tests outside the U.S. and 18 tests in the U.S.

"Cepheid expects to launch faster Xpert tests in conjunction with the availability of the GeneXpert Omni," CMO David Persing said earlier this year. "Compared to an average run-time of about an hour today, we are further optimizing every stage within the cartridge with a goal of delivering test results in as little as 15 minutes, starting with our Xpert Group A Strep assay."

- read the statement