Hologic secures Health Canada approval for Aptima hepatitis C and B Quant assays

13 November 2016 (Last Updated November 13th, 2016 18:30)

Hologic has secured approval from Health Canada for its Aptima HCV and HBV Quant assays.

Hologic has secured approval from Health Canada for its Aptima HCV and HBV Quant assays.

Aptima HCV and HBV Quant assays are nucleic acid amplification tests for the quantitative detection of RNA from hepatitis C-, and DNA from hepatitis B-infected patients.

These assays supplement the presently available Aptima HIV-1 Quant assay, adding to the company’s virology portfolio on the Panther system in Canada.

"For HBV, our test provides accurate, reliable monitoring that contributes to the selection of effective treatment."

The assays offer high-performance in sensitivity and precision parameters, along with sample-to-result automation on the Panther system.

Both the assays offer coverage across a wide linear range and employ several layers of protection for viral detection and quantitation across all major genotypes.

Hologic diagnostic solutions division president Tom West said: “The evolution of the hepatitis C treatment landscape has enabled clinicians to better manage the disease, and the Aptima HCV Quant Dx assay plays an essential role by aiding in the diagnosis of infection and evaluating patients’ response to antiviral therapy.

“For HBV, our test provides accurate, reliable monitoring that contributes to the selection of effective treatment.”

The Aptima HCV and HBV Quant assays run on Hologic’s Panther system, which is integrated platform that completely automates all aspects of testing.

This system singificantly cuts down hands-on time for laboratories by offering random and continuous access with rapid turnaround time.

With the Panther system, laboratorians can run viral load assays for HIV-1, HCV and HBV in parallel and from a single patient sample.