Healthcare Industry News:  liver failure 

Diagnostics Regulatory

 News Release - November 20, 2007

Health Canada Licenses QIAGEN's New Molecular Test for Hepatitis B

The Company's artus® HBV LC PCR Kit improves treatment of HBV infections by monitoring patients' viral load

VENLO, The Netherlands / GERMANTOWN, Md.,--(HSMN NewsFeed)-- November 20, 2007 - QIAGEN today announced that its newly released hepatitis B virus (HBV) assay kit is in compliance with Health Canada's medical device requirements. The artus HBV LC PCR Kit, which monitors the viral load of HBV infected patients, 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 utlilizes the polymerase chain reaction (PCR) amplification technology and is configured for the widely available LightCycler® Instrument. The kit provides all necessary reagents optimized for reliable HBV DNA detection and quantitation - including of the HBV genotypes A-G. This spectrum of genotypes is representative of strains of the virus which 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."

The hepatitis B virus affects millions of people worldwide. Hepatitis B is a serious disease caused by a virus that, among others, attacks the liver. The virus can cause cirrhosis of the liver, liver cancer, liver failure, and even death. The virus is mostly transmitted through blood transfusions, unprotected sexual contact, needle-stick injuries, shared or re-used needles and from infected mothers to newborn babies during birth. Most infected adults are able to fight off the hepatitis B virus. However, some adults and most infected babies and children are unable to rid their bodies of the virus, and develop chronic infections.

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 United States and medical device licenses in Canada to offer its customers in North America more solutions for use in clinical applications. QIAGEN today 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.

Trademarks: QIAGEN®, artus® (QIAGEN Group); LightCycler® (Roche Group).


QIAGEN N.V., a Netherlands holding company is the leading provider of innovative sample and assay technologies and products. QIAGEN's products are considered standards in areas such pre-analytical sample preparation and assay solutions in research for life sciences, applied testing and molecular diagnostics. QIAGEN has developed a comprehensive portfolio of more than 500 proprietary, consumable products and automated solutions for sample collection, nucleic acid and protein handling, separation, and purification and open and target specific assays. The company's products are sold to academic research markets, to leading pharmaceutical and biotechnology companies, to applied testing customers (such as in forensics, veterinary, biodefense and industrial applications) as well as to molecular diagnostics laboratories. QIAGEN employs more than 2,600 people worldwide. QIAGEN products are sold through a dedicated sales force and a global network of distributors in more than 40 countries. Further information about QIAGEN can be found at

Source: Qiagen

Issuer of this News Release is solely responsible for its content.
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