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Health Canada approves Hologic's hepatitis C and B quant assays

Published 11 November 2016

Diagnostic products manufacturer Hologic has received approval from Health Canada for its Aptima hepatitis C and B quant assays.

The Aptima HCV and HBV Quant assays are based on nucleic acid amplification tests used for identifying RNA of hepatitis C and DNA from hepatitis B infected people.

The assays supplement Hologic’s Aptima HIV-1 Quant assay and complete its virology portfolio on the Panther system available in Canada.

Hologic said both the assays perform well under sensitive and precision parameters, along with sample-to-result automation on the Panther system.

They offer coverage across a wide linear range and feature multiple layers of protection for viral identification and quantitation in major genotypes.  

The Aptima HCV and HBV quant assays can run on Hologic’s Panther system, an integrated platform whose major aspects can be automated for testing. The system can significantly reduce hands-on time for laboratories by offering random and continuous access with rapid turnaround time.

The Panther system can be used by laboratories for running viral load assays for HIV-1, HCV and HBV in parallel or from a single patient sample.

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." 

West said: "Laboratories are increasingly seeking to consolidate menu onto a single platform.

"Increasing the range of assays that can be run on the Panther system helps labs reach their efficiency objectives."