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HBV Quant assay receives certification in Europe

Hologic Inc. announced its Aptima hepatitis B virus Quant assay has received CE-IVD certification in Europe and is available for use via their Panther system.

The Aptima HBV Quant assay quantifies HBV DNA using a dual-target approach for accurate quantification and will be able to tolerate various mutations in the HBV genome, according to a press release.

This new assay will be able to be used in parallel with the Aptima HCV Quant Dx assay and the Aptima HIV-1 Quant Dx assay or from one patient sample when used on the Panther system. The combination of the assays used on this system enables sensitive and precise amplification, as well as sample-to-result automation, according to the release.

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

The assays are not currently approved for use in the U.S.

Disclosure: Egstrand is employed by Hologic.