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FDA Clears Hologic MDx Assay for Gastrointestinal Illness

NEW YORK (GenomeWeb News) – Hologic said today that the US Food and Drug Administration has cleared its Prodesse ProGastro SSCS assay for marketing in the US.

Hologic acquired the technology when it bought Gen-Probe last summer. The real-time, multiplex PCR assay is for the qualitative detection of Salmonella, Shigella, and Campylobacter (C. jejuni and C.coli only undifferentiated) nucleic acids and Shiga Toxin 1 (stx1) and Shiga Toxin 2 (stx2) genes.

Hologic said the assay runs on a common benchtop instrument available in many labs and will provide results in hours. By comparison, culture tests may take 48 hours or more for results.