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Medical Devices / Submissions and Approvals

Hologic Wins FDA Nod for Hepatitis B Assay

Jan. 26, 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.

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