First Published Study of New HPV Test for Developing Countries Shows High Accuracy in Predicting Cervical Disease



    
    QIAGEN's careHPV test provides 'substantially more accurate' front-line
    screening
    

    VENLO, Netherlands, Sept. 21 /CNW/ -- A new HPV test developed by QIAGEN
specifically for use in regions of the world with scarce resources is
"substantially" more accurate in identifying women with cervical disease than
the current methods (Pap testing and visual inspection) in these countries.
The first published study of patient outcomes with QIAGEN's careHPV test --
developed with support from PATH, a non-profit global health organization --
appears in the October issue of Lancet Oncology.
    The new test for HPV (human papillomavirus), the primary cause of
cervical cancer, is being developed by QIAGEN NV (Nasdaq:   QGEN; Frankfurt,
Prime Standard: QIA) in partnership with PATH, which receives funding for this
project from the Bill and Melinda Gates Foundation.  The careHPV test is
specially designed to allow women in areas with scarce healthcare resources to
benefit from the advanced technology of HPV testing: It produces rapid,
accurate results, yet is also simple to run, requires minimal infrastructure
and will be affordable for public-health programs in these countries. The
product is expected to be available for pilot programs early in 2009 and more
widely in the second half of that year.
    "QIAGEN is rapidly expanding our leadership position 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," says Peer Schatz, CEO of QIAGEN. "While it is
relatively common for healthcare companies to provide their products at
reduced prices or simplified form for low-income populations, QIAGEN has gone
further. QIAGEN has adapted the most advanced technologies to develop a new
molecular HPV DNA test that achieves high performance targets, yet can be made
available to under-served regions at a very affordable price."
    The first published study of patient outcomes with careHPV involved more
than 2,500 women age 30-54 in mostly rural areas of China. In developed
regions with established public health budgets and programs, Pap testing
(cytology) is the standard screen for cervical disease, supplemented by HPV
testing in women over the age of 30 (who are most at risk). However, both the
Pap and the current HPV test require "a level of infrastructure unattainable
in most of the developing world," write the paper's authors. Thus, the most
common cervical cancer screening tool in low-resource regions of China and
similar countries has been visual inspection with acetic acid (VIA) -- a
procedure in which a woman's cervix is painted with vinegar to highlight any
abnormal areas present, then visually examined by a doctor or nurse. However,
VIA misses a significant number of women with cervical disease who need
treatment: In the study published in Lancet Oncology, the "sensitivity" of VIA
(its ability to identify women who have moderate or severe cervical disease,
also called CIN2+) was 41 percent. In contrast, the sensitivity of careHPV was
90 percent when samples of cervical cells collected by healthcare workers were
used, and 81 percent when women used a vaginal "self-sampling" device. In this
study, careHPV was more sensitive even than the newer, liquid-based Pap
testing, for which the sensitivity was 85 percent when the sample was
collected in the doctor's office. Pap testing, which requires trained
technicians to interpret, is the primary screening tool in many countries.
    The careHPV 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 testing itself is conducted on easily portable equipment and will
run on batteries.
    "In countries with scarce resources, women often live in environments
with few amenities or healthcare staff. In this study, the careHPV test was
effectively run by inexperienced, newly trained, minimally educated
technicians under difficult conditions of temperature, humidity, lighting and
space," said Attila Lorincz, PhD, senior author of the study and a professor
of molecular epidemiology at Barts and the London School of Medicine, as well
as London's Queen Mary College. "Another advantage of careHPV is that it can
produce results within two and a half hours, allowing treatment to be
administered during the same visit -- a critical requirement when women would
likely not be able to return for follow-up care if sent home after their
exam."

    About HPV and cervical cancer (www.theHPVtest.com)

    Cervical cancer affects nearly 500,000 women around the world every year
and kills more than 300,000 -- of which 85 percent are in developing
countries. After breast cancer, it 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 QIAGEN (www.qiagen.com)

    QIAGEN NV is the leading global provider of sample and assay
technologies, with its global headquarters in the Netherlands. Sample
technologies are used to isolate and process DNA, RNA and proteins from
biological samples such as blood or tissue, and assays make these isolated
molecules visible to facilitate such vital activities as biological research
and detection of disease. QIAGEN has developed and markets more than 500
products as well as instruments that make their use more efficient and
accurate. 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 one of the broadest panels of molecular diagnostic tests
available worldwide, including the only FDA-approved test for human
papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs
more than 2,600 people in over 30 locations worldwide.




For further information:

For further information: Pam Rasmussen (U.S.), +1-240-686-7616,
Pamela.Rasmussen@qiagen.com; or Thomas Theuringer (Germany),
+49-2103-29-11826, Thomas.Theuringer@qiagen.com, both of QIAGEN; Web Site:
http://www.qiagen.com, http://www.theHPVtest.com

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