German Association of Gynecology and Obstetrics...
Venlo, The Netherlands, August 4, 2008 - New cervical cancer
prevention guidelines issued by the German Association for Gynecology
and Obstetrics (DGGG) recommend testing women 30 and over for HPV
(human papillomavirus) - the primary cause of cervical cancer. The
guidelines recommend that HPV testing be performed along with a Pap
smear for women 30 and older. The digene® HPV Test, developed by
QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA), is currently
the only HPV test approved by regulatory authorities in both Europe
and the United States.
"Our recommendations recognize the large number of scientific studies
that demonstrate greater accuracy in identifying women at risk of
having or developing cervical cancer, when a Pap is combined with the
HPV test, rather than relying on a Pap smear alone," says Professor
Klaus Friese, lead author of the new guidelines and professor of
gynecology at the Ludwig-Maximilians-University in Munich. "By using
both tests for women 30 and over, when cervical cancer is most
common, we hope to greatly reduce the number of women suffering and
dying from this disease."
The DGGG guidelines specifically conclude that the sensitivity of the
Hybrid Capture® II (HC2) technology used by the digene HPV Test is
comparable to PCR, the standard technology used in molecular testing.
However, say the guidelines, the specificity (association with actual
disease) of HC2 is greater than that for PCR.
Every year, cervical cancer affects nearly 500,000 women worldwide
and, after breast cancer, is the second-most-common malignancy in
women. In Germany, 6,200 women are diagnosed with the disease and
1,800 die from it each year. It is estimated that 80 percent of women
will get an HPV infection at some point in their lives. In most
cases, the infection is cleared by the immune system or is suppressed
without causing problems. However, in others, the infection persists,
leading to abnormal cell changes and disease. Early detection allows
early treatment, ideally before cancer develops.
The digene HPV Test has been validated in global studies that
included more than 300,000 women. It has been approved by the U.S.
Food and Drug Administration, is CE-marked in Europe and is also
licensed for sale in many other countries. In Germany, the digene HPV
Test is reimbursed by most private health insurances for routine
screening. Many experts hope that public health insurance will cover
HPV testing in the future for primary screening in conjunction with a
Pap. One pilot screening program already initiated is a partnership
between public health insurer Deutsche BKK, the Wolfsburg clinical
centre and gynecologists in private practice in the city. In the
program, Deutsche BKK covers the cost of the digene HPV Test as a
screening test for participants 30 years and older, in conjunction
with a Pap.
"Unlike other cancers, cervical cancer is virtually 100 percent
preventable - if women and their healthcare providers have access to
the HPV Test and other new advances in preventive care," says Peer
Schatz, CEO of QIAGEN. "The new guidelines from the German
Association of Gynecology and Obstetrics will play a valuable role in
helping physicians - and through them, their patients - understand
the most effective methods for making this disease a tragedy of the
past. QIAGEN welcomes the new guidelines published by the DGGG in
Germany, a country with a population of more than 80 million and in
which the company has a strong presence."
About QIAGEN:
QIAGEN N.V., a Netherlands holding company, is the leading provider
of sample and assay technologies. Sample technologies are used to
isolate and process DNA, RNA, and proteins from biological samples
such as blood or tissue. Assay technologies are used to make such
isolated biomolecules visible. QIAGEN has developed and markets more
than 500 consumable products as well as automated solutions for such
consumables. The company provides its products to molecular
diagnostics laboratories, academic researchers, pharmaceutical and
biotechnology companies, and applied testing customers for purposes
such as forensics, animal or food testing, and pharmaceutical process
control. QIAGEN's assay technologies include what is considered to be
the broadest panel of molecular diagnostic tests available worldwide.
This panel includes the only FDA-approved test for human
papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN
employs more than 2,800 people in more than 30 locations worldwide.
Further information about QIAGEN can be found at
http://www.qiagen.com/.
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the U.S. Securities and Exchange Commission (SEC).
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