Friday, October 6, 2017

Cepheid Xpress Strep A Test Clears FDA

Cepheid's rapid assay for Group A Strep has received clearance from the US Food and Drug Administration. The Xpert Xpress Strep A test is an automated real-time PCR assay that takes as little as 18 minutes to detect Streptococcus pyogenes in DNA from patient throat samples.

The test also "allows patients and their healthcare providers to expect a definitive diagnosis at the point of care, and to avoid the need for lengthy and cumbersome confirmatory bacterial cultures," said Cepheid's Chief Medical and Technology Officer David Persing in a statement. The assay eliminates requirements for culture confirmation of negative results, unless clinical symptoms persist or there is an occurrence of acute rheumatic fever.

This is the third assay on the Xpert Xpress line that was first described by the firm in 2015 and also includes Xpert Xpress Flu and Xpert Xpress Flu/RSV. Xpress tests can be run on the Cepheid GeneXpert molecular diagnostics platform, which has an installed base of more than 11,000 systems in 182 countries. The tests are also slated to run on Cepheid's point-of-care system, Omni, although Cepheid has delayed Omni's development in order to expedite the Xpress tests on its existing GeneXpert systems.

Although antibiotic treatment of acute pharyngitis, or "strep throat," is often initiated inappropriately for illness caused by viruses, a lack of guidelines from professional societies regarding molecular testing for Group A Strep testing has been previously thought to have impacted uptake of rapid, near-patient testing from other firms.

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