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# FDA Clears Hologic Group B Strep Assay
- URL: https://www.fdaweb.com/fda-clears-hologic-group-b-strep-assay/
- Published: 2018-08-02T12:00:00.000Z
- Updated: 2026-09-15T00:23:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142030

FDA has cleared a Hologic 510(k) for its Group B *Streptococcus* (GBS) assay on the Panther Fusion system. The company says clinical research has showed that the assay exhibited 100% sensitivity compared to culture-based testing methods. “The assay will also increase testing options for healthcare providers, as it is validated for the two enrichment broths that make up 95% of the samples used on the market,” it adds. The assay also has less stringent requirements for clinical sample storage and transport than culture-based tests.