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

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

November 08, 2007

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


    BEIJING, Nov. 8 /Xinhua-PRNewswire/ -- 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 .



    For more information, please contact:

    QIAGEN (formerly Digene)

     Pam Rasmussen
     Tel:   [phone]
     Email: [e-mail]

     Thomas Theuringer
     Tel:   [phone]
     Email: [e-mail]

     Sue-Lane Wood
     PATH
     Tel:   [phone]
     Email: [e-mail]