NEW YORK (GenomeWeb News) – Cepheid today said that the US Food and Drug Administration has granted an Emergency Use Authorization for the firm's Xpert Flu A Panel test.
The test runs on the firm's GeneXpert System and can identify the 2009 H1N1 influenza virus in less than one hour, said Cepheid. In addition, Cepheid said that it is the first test for the virus granted an EUA for CLIA moderate complexity labs, which means it can be performed in hospital near-patient settings.
"Although PCR testing is now recognized as the new gold standard for detection of influenza virus infection, test availability for 2009 H1N1 has so far been limited to high-complexity laboratories and results are not typically available around the clock," Cepheid CEO John Bishop said in a statement. He said that the Cepheid test is unique as it "combines the convenience and ease-of-use of rapid testing with the performance of PCR."
Cepheid is the latest of several firms, as well as the US Centers for Disease Control and Prevention, to be granted an EUA for H1N1 influenza A assays. Among the other firms to receive EUA's for their assays are Focus Diagnostics, which is owned by clinical lab giant Quest Diagnostics, Gen-Probe's Prodesse business, clinical lab Diatherix Laboratories, Roche, DxNA, and TessArae.
Cepheid said that it will continue developing an expanded influenza test panel that it expects will include tests for Influenza A with strain identification for H1 seasonal and H3 seasonal influenza A subtypes, the 2009 H1N1 subtype, and influenza B. The firm said that it expects to submit a separate 510(k) application with the FDA this year for that panel. It also expects the panel to be available in Europe as a CE IVD Mark product.