NEW YORK (GenomeWeb) – Cepheid announced today its near-patient assay to detect Group A Strep infection, a common cause of "strep throat" acute pharyngitis, has been CLIA waived.
The test called the Xpert Xpress Strep A test was cleared last year by the US Food and Drug Administration to run on the firm's GeneXpert molecular diagnostics platforms. Cepheid has since obtained FDA clearance and CLIA waiver for two multi-module platforms, called GeneXpert Xpress II and GeneXpert Xpress IV, and a company representative confirmed the Strep A test can run on these other GeneXpert systems as well.
The Xpert Xpress Strep A test detects Streptococcus pyogenes DNA in as little as 18 minutes. The rapid results may facilitate antimicrobial stewardship in the outpatient setting, David Persing, Cepheid's chief medical and technology officer, said in a statement.
The FDA approval also stipulated that there are no requirements for culture confirmation of negative results unless clinical symptoms persist or in situations where there is an outbreak of acute rheumatic fever.
The Xpert Xpress line — faster versions of the firm's Xpert test cartridges that enable test times of 30 minutes or less — was first described by Cepheid in 2015 and also includes Xpert Xpress Flu and Xpert Xpress Flu/RSV.