www.fdanews.com/articles/185370-hologic-wins-fda-nod-for-hepatitis-b-assay
Hologic Wins FDA Nod for Hepatitis B Assay
January 25, 2018
Hologic received PMA approval for its Aptima HBV Quant Assay for measuring hepatitis B viral load on its automated Panther system.
The assay joins two other Hologic viral load assays for use on the Panther system – one for human immunodeficiency virus and one for hepatitis C virus.
They assays all use the company’s proprietary real-time transcription-mediated amplification technology and provide sample-to-result automation.