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Cepheid Flu/RSV Test Gets FDA Clearance, CLIA Waiver

NEW YORK (GenomeWeb) – An assay from Cepheid to detect influenza A and B as well as respiratory syncytial virus has been cleared by the US Food and Drug Administration and granted CLIA waiver, the company said today.

An Xpert Xpress Flu/RSV test was previously cleared by the FDA last year. The new clearance and waiver is for an enhanced version of the test and covers nasopharyngeal swabs as well as less-invasive nasal swab specimens. The test yields results in as little as 20 minutes. It uses automated reverse-transcription real-time PCR and detects multiple segments of influenza viral RNA to improve strain coverage and prevents loss of sensitivity due to antigenic drift and shift, the firm said in a statement.

Cepheid has a single-module CLIA-waived instrument for near-patient and point-of-care settings, as well as two- and four-module instruments. "Our first-in-class multi-module system deals effectively with the surge of tests demanded by a severe flu season and frees up the laboratory to conduct other more complicated tests," said David Persing, Cepheid's chief medical and technology officer.

The flu/RSV test adds to a menu of CLIA-waived tests that now includes Strep A and a test for flu A and B. These assays "provide medically actionable and timely information to clinicians to support improved patient management, and antibiotic and antiviral stewardship," Persing said.

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