CLN Article

Hologic Earns FDA Approval for Hepatitis B Assay

Regulatory Roundup: April 2018

The Food and Drug Administration has granted approval to Hologic for the Aptima HBV Quant assay for quantitation of hepatitis B viral (HBV) load on the fully automated Panther system. This assay quantitates HBV DNA across all major genotypes A-H using Hologic’s proprietary real-time transcription-mediated amplification. Its dual-target approach delivers accurate quantitation over a broad linear range, from 10 IU/mL to 1 billion IU/mL, ensuring precise results even for samples with the high viremia often associated with chronic HBV infection. The assay also tolerates potential mutations in the HBV genome.

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