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

    BEIJING, Nov. 8 /PRNewswire-FirstCall/ -- 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 (http://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 (http://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 http://www.theHPVtest.com.

SOURCE QIAGEN N.V.