Study Finds New Version of QIAGEN's HPV Test for Developing Countries Could Reduce Risk of Cervical Cancer by More than Half When Combined With Appropriate Treatment

Beijing, November 8 (ots/PRNewswire) -

- Research Shows the New Test is Accurate, Simple to Run and
Requires Minimal Resources

Research demonstrating the potential of a special type of HPV test
developed by QIAGEN with support from PATH -- a non-profit global
health organization -- to reduce the incidence of cervical cancer in
low-resource regions of the world were presented this week at the
24th International Papillomavirus Conference in Beijing, People's
Republic of China. An economic modeling analysis found that the
"FastHPV" test, which is being developed specifically for cervical
cancer screening in countries such as China and India, could reduce
the incidence of cervical cancer by as much as 56 percent if given
just three times over a woman's life and combined with appropriate
treatment. In addition, a clinical research study concluded that the
FastHPV test produces rapid, accurate results, yet is also simple to
run, requires minimal infrastructure and will be affordable for
public-health programs in those countries.

FastHPV -- a molecular test for cancer-causing types of HPV (human
papillomavirus) -- is under development by QIAGEN N.V. (Nasdaq: QGEN;
Frankfurt, Prime Standard: QIA) in partnership with PATH. The test --
on track to be submitted for its first regulatory approvals in
countries like China and India in 2008 -- is specially designed to
allow women in areas with scarce healthcare resources to benefit from
the advanced technology of HPV testing.

"It is relatively common for healthcare companies to provide their
products and services at reduced prices to countries with minimal
healthcare infrastructure and large low-income populations," says
Peer Schatz, CEO of QIAGEN. "With our new FastHPV test, QIAGEN has
gone beyond that standard approach and has specifically adapted the
HPV DNA test it sells in the developed world to meet the special
needs of women and their healthcare providers in these very
challenging settings. What is remarkable is that while the FastHPV
test uses very advanced molecular diagnostic technologies, it is
packaged into a solution that can be run in almost any environment
and by almost any operator. QIAGEN is already the leader in molecular
diagnostics in the developed world, and we take very seriously our
commitment to make improvements in life possible for everyone, no
matter what their socioeconomic status."

The FastHPV test can be conducted by workers with minimal
healthcare training and education. Once collected, samples of vaginal
or cervical cells are prepared for analysis using a kit of reagents
that contains its own water supply. The kit's stability has been
demonstrated for more than eight months at room temperature, and
conditions as extreme as 104 degrees F. -- 40 degrees C. -- can be
tolerated for up to a month. The testing itself is conducted on
easily portable equipment and will, when introduced, run on
batteries.

Human papillomavirus is the primary cause of cervical cancer,
which affects nearly 500,000 women around the world every year and
kills more than 250,000 -- of which 80 percent are in developing
countries. The High-Risk hc2 HPV DNA Test(R) developed by Digene
Corp. (now part of QIAGEN) is emerging as a standard of care for
identifying women at risk. In the United States, HPV testing has been
approved by the U.S. Food and Drug Administration for use along with
cytology (commonly called the Pap smear) in women 30 and over.
However, the infrastructure (such as clean water and electricity) and
trained personnel required for Pap smears are not usually feasible
for low-resource regions.

In addition, in these regions, transportation and other obstacles
prevent easy access to medical clinics, necessitating rapid
availability of test results so that follow-up care -- if needed --
can be initiated quickly, ideally the same day. FastHPV has been
designed to be used as a stand-alone diagnostic test to screen women
for cervical cancer risk, producing results in less than two and a
half hours.

The first clinical study of FastHPV to be reported, which was
summarized at the conference in Beijing, was conducted as part of
PATH's Screening Technologies to Advance Rapid Testing (START)
project. It involved more than 2,500 women age 30-54 in mostly rural
areas of China, where the World Health Organization has found that
diseases are the cause of poverty for up to half of the population.
Because cytology is not practical in such regions, the most common
cervical cancer screening tool has been visual inspection with acetic
acid (VIA), in which the cervix is painted with vinegar to better
highlight any abnormal areas present, then examined by a healthcare
professional. However, in this study, VIA was not very accurate; its
sensitivity (ability to identify women who have severe, pre-cancerous
cervical disease) was only 41 percent. In contrast, the sensitivity
of FastHPV was 86-90 percent when samples of cervical cells collected
by healthcare workers were used, and 72-81 percent when women
collected their own samples using a vaginal collection device.

"Unlike other cancers, cervical cancer has a single, known cause:
HPV. That makes the disease highly preventable -- if abnormal cells
are found and treated early. This research clearly shows that the
ability of FastHPV to accurately identify women with pre-cancerous
cervical disease is substantially better than visual inspection and
approaching that of the technology used for HPV DNA testing in
high-resource countries (QIAGEN's proprietary hc2 platform),"
concluded Professor Youlin Qiao, who led the China study and serves
as Chief of the Department of Cancer Epidemiology at the Chinese
Academy of Medical Sciences. "FastHPV is very promising as a
realistic method for public-health cervical cancer prevention
programs in low-resource settings like many areas of rural China."

In a separate presentation in Beijing, John Sellors, MD, Senior
Medical Advisor at PATH and START project director, discussed the
results of an economic model that projected the impact if women in
low-resource countries were to be tested with FastHPV just three
times in their lives -- 5 years apart, after age 35. This analysis
found that cervical cancer could be reduced by 56 percent, assuming
that the majority of women participated and effective treatment is
available. The best results would be achieved when using a
"screen-and-treat" approach that allows women found to have the virus
to be treated for possible disease in the same visit. Standard
protocols in North America and Europe call for women with a positive
HPV test to be re-screened later to confirm that the infection has
not naturally resolved, and/or to confirm the presence of cervical
disease with a biopsy. However, this is not feasible or affordable in
low-resource settings, and many women would fail to return for the
required follow-up visits.

Dr. Sellors and his colleagues add that while vaccination of
adolescents against the most common types of HPV would be expected to
reduce the incidence of cervical cancer even further, its
cost-effectiveness will depend on price and the ability to ensure
compliance with the necessary protocol, which currently calls for
three shots over six months.

About HPV and cervical cancer

Worldwide, cervical cancer affects nearly 500,000 women annually
and, after breast cancer, is the second-most-common malignancy found
in women. Cervical cancer is caused by "high-risk" types of the human
papillomavirus (HPV), which are sexually transmitted. It's estimated
that 80 percent of women will get an HPV infection at some point in
their lives. However, in most cases, the infection goes away or is
suppressed by the body without causing problems. It is only
infections that persist that can cause abnormal cells to form that
may develop into cervical cancer if not detected and treated early.
One report from the World Health Organization estimates that only
about 5 percent of women had been screened for cervical disease in
the previous five years, compared to 40-50 percent in the developed
world.

About PATH (www.path.org)

PATH is an international, nonprofit organization that creates
sustainable, culturally relevant solutions, enabling communities
worldwide to break longstanding cycles of poor health. By
collaborating with diverse public- and private-sector partners, PATH
helps provide appropriate health technologies and vital strategies
that change the way people think and act. PATH's work improves global
health and well-being. Headquartered in Seattle, Washington, USA,
PATH has 29 offices in 18 countries. PATH currently works in more
than 65 countries in the areas of health technologies, maternal and
child health, reproductive health, vaccines and immunization, and
emerging and epidemic diseases.

About QIAGEN (www.qiagen.com)

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 as
pre-analytical sample preparation and assay solutions for life
sciences, applied testing and molecular diagnostics. QIAGEN has
developed a comprehensive portfolio of more than 500 proprietary,
consumable products and automated solutions. The company's products
are sold to academic research markets, leading pharmaceutical and
biotechnology companies, applied testing customers (such as in
forensics, veterinary, biodefense and industrial applications) and
molecular diagnostics laboratories. QIAGEN products are sold through
a dedicated sales force and a global network of distributors in more
than 40 countries; the company employs more than 2,600 people
worldwide. Further information about HPV DNA testing specifically can
be found at www.theHPVtest.com.

Web site: http://www.thehpvtest.com
http://www.qiagen.com
http://www.path.org

ots Originaltext: Qiagen N.V.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Pam Rasmussen, +1-240-506-0766, Pamela.Rasmussen@digene.com, or
Thomas Theuringer, +49-2103-29-1826, Thomas.Theuringer@qiagen.com,
both of QIAGEN (formerly Digene), or Sue-Lane Wood, PATH,
+1-206-310-9121, suelanewood@path.org


	hier anmelden...