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.

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