Hologic receives EU approval for Aptima HBV Quant assay

Hologic has announced that its Aptima HBV Quant for hepatitis B virus (HBV) testing has received European regulatory approval.

Designed for use with the fully automated Panther instrument, the assay has received CE-IVD certification, expanding Hologic's European virology menu. The Aptima HIV-1 Quant Dx and Aptima HCV (hepatitis C virus) Quant Dx viral load assays are already available.

The assay quantitates HBV DNA across all major genotypes and offers the only dual-target approach that delivers accurate quantitation over a broad linear range, while tolerating potential mutations in the HBV genome.

Providing one of the broadest linear ranges on the market, the test helps to ensure precise quantitation even for samples with high viremia levels.

Claus Egstrand, Hologic's international group president, said: "We are excited to now offer European customers three important viral load assays on our Panther system. Laboratories can now quantify HIV-1, HCV and HBV accurately while benefiting from random access and more walkaway freedom."

The Panther system's assay menu also includes tests for chlamydia, gonorrhea, trichomoniasis, HPV and HPV genotyping.