Great Basin Files for FDA OK of Group B Strep Assay | GenomeWeb

NEW YORK (GenomeWeb) – Molecular diagnostics firm Great Basin Scientific today announced it has submitted a 510(k) application to the US Food and Drug Administration for marketing clearance of its Group B Strep assay for perinatal infections.

The sample-to-result assay is used to detect Streptococcus agalactiae from vaginal and rectal swabs collected from antepartum women around weeks 35 to 37 of pregnancy. The results help physicians determine if the woman needs antibiotic treatment to help prevent transmission of an infection during child birth.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In Science this week: metagenomic-based technique for determining protein structure, and more.

An academic laments the rise of narcissism in the sciences, the Guardian reports.

Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.

The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.