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October 2018
Strep Assay Gains FDA Clearance
By: Hologic, Inc

Hologic has been granted US FDA clearance for the Panther Fusion Group B Streptococcus (GBS) assay, which brings automation to GBS bacterium detection, as clinical research showed that it exhibited 100% sensitivity. The assay will increase testing options for health care providers, as it is validated for the two enrichment broths that make up 95% of the samples used on the market. It also maintains less stringent requirements for clinical sample storage and transport than culture-based tests.

Hologic, Inc

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