FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Hologic Wins FDA Nod for Hepatitis B Assay

Jan. 26, 2018
A A

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.

View today's stories