German Association of Gynecology and Obstetrics Recommends HPV Testing for Cervical Cancer Screening
SOURCE:
Qiagen N.V.
2008-08-04 15:09:00
German Association of Gynecology and Obstetrics Recommends HPV Testing for Cervical Cancer Screening
VENLO, THE NETHERLANDS–(EMWNews – 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 (
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
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products to integrated solutions and producing such products,
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market
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acquired
technologies and businesses. For further information, refer to
the
discussions in reports that QIAGEN has filed with, or furnished
to,
the U.S. Securities and Exchange Commission (SEC).
Copyright © Hugin AS 2008. All rights reserved.
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