NEW YORK (GenomeWeb) – Hologic said today that the US Food and Drug Administration has granted premarket approval for its Aptima HBV Quant Assay for quantitation of hepatitis B viral load on its fully automated Panther system.
The assay reliably quantitates HBV DNA across genotypes A-H, provides a dual-target approach that delivers accurate quantitation over a broad linear range, and tolerates potential mutations in the HBV genome, Hologic said.