FDA Grants 510(k) Clearance to Cepheid for Xpert Flu+RSV Test

December 8, 2015

The FDA has awarded Cepheid 510(k) clearance and Clinical Laboratory Improvement Amendments waiver for its Xpert Flu+RSV Xpress test for use on the GeneXpert Xpress System.

The GeneXpert Xpress System is the first in a series of reference-quality molecular tests that Cepheid plans to deliver over the next several years.

The Xpert Flu+RSV Xpress test features high-level multiplexing, redundant target segments and extended coverage for human and avian influenza strain, according to Cepheid's Chief Medical and Technology Officer David Persing. — Michael Cipriano