Cepheid Gets FDA Clearance and CLIA Waiver for Flu Test

Sunnyvale, Calif.-based Cepheid Inc. has earned U.S. Food and Drug Administration (FDA) 510(k) clearance and a clinical laboratory improvement amendments (CLIA) waiver for the Xpert Flu+RSV Xpress test for use on the Genexpert Xpress system. A CLIA waived test is one defined as a simple laboratory examination or procedure that have an insignificant risk of an erroneous result.

The Genexpert Xpress system is a customized Genexpert system comprised of a single module and a tablet computer with an ATM-like interface specifically for the CLIA waived environment. Xpert Flu+RSV Xpress is the first polymerase chain reaction (PCR) panel test to achieve CLIA waiver, and the first in a series of reference-quality molecular tests that Cepheid intends to deliver to the point of care market over the next several years.

“There are more than 1 billion visits annually to physicians’ offices in the United States and yet, until recently, CLIA waived testing sites have not had access to the same levels of accuracy found in sophisticated hospital or reference laboratories,” said John Bishop, Cepheid’s chairman and CEO. “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.”

“The Flu+RSV Xpress test uses the same design as our lab-based Flu/RSV XC test, which has already shown in several studies, to provide performance that meets or exceeds that of other conventional molecular testing run in hospital or reference labs,” added David Persing, M.D., Ph.D, Cepheid’s chief medical and technology officer. “Novel design features of this test include high-level multiplexing, redundant target segments, and extended coverage for human and avian influenza strains – a first in the industry for the CLIA waived market and an important step towards pandemic preparedness.”

Cepheid’s Xpert Flu/RSV XC test has been available for CLIA moderate complexity customers since November 2014. The Xpert Flu+RSV Xpress test uses the same test cartridge as the Xpert Flu/RSV XC test and will be available for customers in CLIA-waived settings in December. Both Cepheid’s Xpert Flu/RSV XC and Xpert Flu+RSV Xpress tests detect and differentiate between influenza A, influenza B, and respiratory syncytial virus, in about one hour, the company reports.