FDAnews
www.fdanews.com/articles/101283-health-canada-licenses-qiagen-rsquo-s-molecular-test-for-hepatitis-b

Health Canada Licenses Qiagen’s Molecular Test for Hepatitis B

November 20, 2007

Qiagen’s newly released hepatitis B virus (HBV) assay kit, the artus HBV LC PCR Kit, has been approved by Health Canada and is now available to doctors there.

The ready-to-use molecular diagnostic detection kit for the quantitation of hepatitis B viral DNA from plasma helps monitor ongoing drug therapy treatments for people chronically infected with hepatitis B, the company said. The kit uses the polymerase chain reaction amplification technology and is configured for the LightCycler Instrument.

The kit provides all necessary reagents optimized for reliable HBV DNA detection and quantitation — including the HBV genotypes A-G, according to Qiagen.