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Group B Strep Test From DiaSorin Molecular Cleared by FDA

NEW YORK (GenomeWeb) – DiaSorin Molecular announced today the US Food and Drug Administration has cleared the firm's Simplexa GBS Direct assay.

The assay is designed for use on DiaSorin Molecular's Liaison MDX instrument and enables the qualitative detection of group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Results from the test can be used in assessing the colonization status of such women, and the assay can be used to replace traditional culture-based testing methods, DiaSorin Molecular said.

The Simplexa GBS Direct assay received CE marking in October and is the ninth assay for infectious disease for use on the company's PCR-based Liaison platform to receive FDA clearance.

According to the Cypress, California-based firm — which is part of Italy-based DiaSorin — group B Streptococcus is a leading cause of early onset neonatal sepsis with 1 in 4 pregnant women estimated to be colonized by GBS bacteria.