NEW YORK (GenomeWeb) – Cepheid announced today that it has received 510(k) clearance and CLIA waiver from the US Food and Drug Administration for a new test system and influenza molecular diagnostic test.
The test, called Xpert Xpress Flu, can be used in near-patient settings to detect both A and B strains of influenza from either nasopharyngeal or nasal swabs. It targets multiple regions within the RNA-based influenza genomes to increase sensitivity and guard against antigenic drift.