Skip to main content
Premium Trial:

Request an Annual Quote

Cepheid Xpress Strep A Test Clears FDA

NEW YORK (GenomeWeb) – 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. 

The Scan

Panel Votes for COVID-19 Pill

A US Food and Drug Administration panel has voted to support the emergency use authorization of an antiviral pill for COVID-19 from Merck and Ridgeback Biotherapeutics, CNN says.

But Not Harm

New Scientist reports that UK bioethicists say that though gene editing may improve food production, it should not harm livestock welfare.

Effectiveness Drop Anticipated

Moderna's Stéphane Bancel predicts that that current SARS-CoV-2 vaccines may be less effective against the Omicron variant, the Financial Times reports.

Cell Studies of Human Chromatin Accessibility, SARS-CoV-2 Variants, Cell Signaling Networks

In Cell this week: chromatin accessibility maps of adult human tissues, modeling to track SARS-CoV-2 variants of concern, and more.