Cepheid Gets 510 (K) Marketing Clearance, CLIA Waver For Xpert Flu+RSV Xpress

(RTTNews) - Molecular diagnostics company Cepheid (CPHD) Monday said it received FDA's 510(k) marketing clearance and Clinical Laboratory Improvement Amendments or CLIA waiver for the Xpert Flu+RSV Xpress test for use on the GeneXpert Xpress System.

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.

The Xpert Flu+RSV Xpress test utilizes 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 RSV, in about one hour.