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# Hologic PMA Approved for Hepatitis B Assay
- URL: https://www.fdaweb.com/hologic-pma-approved-for-hepatitis-b-assay/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140613

FDA has approved a Hologic PMA for the Aptima HBV Quant Assay for calculating hepatitis B viral load on the fully automated Panther system. The assay offers a unique, dual-target approach that delivers “accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome,” the company says. The new product joins previously approved Aptima HIV-1 Quant Assay (for human immunodeficiency virus) and Aptima HCV Quant Dx Assay (for hepatitis C virus) on the Panther system. All three assays use Hologic’s real-time transcription-mediated amplification.