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., 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
"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
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 www.qiagen.com.
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Dr. Thomas Theuringer Nicole York
Associate Director, Public Relations Marketing Communications
Tel: 0049-2103-29-11826 Manager
Email: email@example.com Tel.: 001-240-686-7660