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Cepheid GeneXpert Xpress, Influenza MDx Receive FDA 510(k) Clearance, CLIA Waiver

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.

The flu test was cleared along with the GeneXpert Xpress System, a platform that can run up to four Xpress tests at a time. This multi-module system was "designed for greater surge capacity and menu versatility," David Persing, Cepheid's chief medical and technology officer, said in a statement.

The Xpress tests rely on real-time PCR, like the firm's GeneXpert molecular assays, but Cepheid has developed the Xpress line to run faster by altering the chemistry within test cartridges, as previously reported.

Cepheid obtained clearance and CLIA waiver on an influenza and respiratory syncytial virus test using its GeneXpert platform in 2015, and XPress flu and flu/RSV tests on the GeneXpert platform last year prior to being acquired by Danaher.