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New molecular test for hepatitis B is now available to Canadian doctors

QIAGEN : 20 November, 2007  (New Product)
Qiagen’s artus HBV LC PCR Kit is a new hepatitis B virus (HBV) assay that monitors the viral load of HBV infected patients and is now available to doctors in Canada to help them determine the success of a treatment.
The ready-to-use molecular diagnostic detection kit for the quantitation of hepatitis B viral DNA from plasma helps to monitor on-going drug therapy treatments for those people chronically infected with hepatitis B. The kit utlilises the polymerase chain reaction (PCR) amplification technology and is configured for the widely available LightCycler Instrument.

The kit provides all necessary reagents optimised for reliable HBV DNA detection and quantitation - including of the HBV genotypes AG. The spectrum of genotypes is representative of strains of the virus that can be found globally, ensuring highest sensitivity in monitoring of treatments.

“Qiagen is pleased to have gained compliance from Health Canada. We look forward to making our new HBV Assay kit available to our customers and thereby to patients chronically infected with hepatitis B in Canada,“ said Doug White, senior vice president sales and marketing for the Americas. “The artus HBV kit will play an important role in assisting healthcare workers in monitoring hepatitis B patients’ viral load. This is extremely important for the implementation and administration of successful therapy.“

Qiagen has the broadest offering of molecular diagnostic tests in the world. The company is currently seeking further pre-market approvals and clearances in the USA and medical device licenses in Canada to offer its customers in North America more solutions for use in clinical applications.

Qiagen sells a number of products approved or cleared for in-vitro diagnostic use in the United States, including the only FDA approved test for the human Papillomavirus, which plays a key role in cervical cancer screening and prevention.

The QIAamp DSP Virus Kit DNA isolation method has been validated for use with the artus HBV LC PCR Kit.

The artus HBV LC PCR Kit is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.

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