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# FDA Clears GenePOC GBS LB Assay
- URL: https://www.fdaweb.com/fda-clears-genepoc-gbs-lb-assay/
- Published: 2017-06-02T12:00:00.000Z
- Updated: 2026-09-14T22:27:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138844

FDA has cleared a GenePOC 510(k) for its GBS LB assay and its revogene instrument, a molecular diagnostic for identifying antepartum Group B *Streptococcus* colonization in newborns. Clearance was based on data from a clinical validation study that compared the assay to a standard culture. The assay used vaginal and rectal swabs from pregnant women enriched in LIM broth for 18-24 hours prior to testing, according to the company. It had “high sensitivity and specificity during validation studies and clinical trials,” it says, adding that it provided the results up to 18 hours faster than standard culture.