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# FDA Approves Hologic Hepatitis C Virus Assay
- URL: https://www.fdaweb.com/fda-approves-hologic-hepatitis-c-virus-assay/
- Published: 2017-02-16T12:00:00.000Z
- Updated: 2026-09-14T22:07:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138007

FDA has approved a Hologic PMA for its hepatitis C virus (HCV) assay for quantitation of HCV viral load and confirming active HCV infection on the fully automated Panther system. The test uses real-time transcription-mediated amplification (TMA), “which provides highly sensitive and specific performance for diagnostic use, as well as reliable quantitation for determination of sustained antiviral response across all major genotypes and a wide linear range,” the company says. The Panther system also tests HIV-1 (human immunodeficiency virus) viral load, and detects sexually transmitted infections – chlamydia, gonorrhea, trichomonas and human papillomavirus.