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Medical Devices / Submissions and Approvals

FDA Grants PMA Approval for Hologic's Assay

Feb. 17, 2017

Massachusetts–based, Hologic has received PMA approval from the FDA for its hepatitis C virus assay for measuring viral load and confirming infection.

The Aptima HCV Quant Dx assay uses real-time transcription-mediated amplification, which provides sensitive and specific performance for diagnostic use, and measures sustained antiviral response across all major genotypes.

The assay runs on the automated Panther system, which reduces hands-on time with random and continuous access.

The assay is CE-IVD marked for diagnostic and viral load monitoring in Europe. — Cynthia Jessup

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