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Wednesday 01 April, 2009


Landmark Study in The New England Journal of Me...

VENLO, Netherlands, April 1 /PRNewswire/ --

    - QIAGEN donates one million tests to expand access to HPV screening in
the world's poorest countries

    Results from an eight-year trial involving more than 130,000 women
published today in The New England Journal of Medicine (NEJM) demonstrate
that in low-resource settings a single round of HPV testing significantly
reduces the numbers of advanced cervical cancers and deaths, compared with
Pap (cytology) testing or visual inspection with acetic acid (VIA). The trial
used QIAGEN's (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) digene HPV Test,
which detects high-risk types of human papillomavirus that cause cervical

    "The implications of the findings of this trial are immediate and global:
international experts in cervical-cancer prevention should now adapt HPV
testing for widespread implementation," wrote Drs. Mark Schiffman and Sholom
Wacholder of the U.S. National Cancer Institute in an editorial that
accompanied the study in the NEJM. "The remarkable promise of the Indian
trial presents a worthy global challenge to implement smart, regionally
tailored strategies that will efficiently save millions of lives in the years

    Following this milestone study, over the next five years QIAGEN will
donate one million HPV tests, with a total estimated value of over US$30
million (based on U.S. list prices), as part of its broader global access
program to provide the highest quality cervical cancer screening technologies
to women in developing countries. Nearly 300,000 women die of cervical cancer
every year, with 80% of deaths occurring in developing countries.

QIAGEN's commitment to expanded access to HPV screening includes:

    -- HPV test donation programs, in partnership with leading public health
       institutions and health non-governmental organizations (NGOs)
    -- Development of next-generation HPV technologies, including the careHPV
       test - designed specifically for low-resource, developing countries
    -- Tiered-pricing initiatives for low-resource countries

    "This landmark study further validates the value of QIAGEN's HPV test as
the gold standard for cervical cancer screening and demonstrates that the
incidence of advanced cervical cancer and deaths are actually reduced -- and
hence lives saved -- when HPV screening is implemented," said Peer Schatz,
Chief Executive Officer of QIAGEN. "QIAGEN's HPV testing technology is
already being used to routinely screen millions of women in the United States
and Europe. We're committed to working together with the public health
community to ensure that women everywhere have access to the best cervical
cancer prevention tools." Moving forward QIAGEN will collaborate with a team
of global health partners -- including the International Planned Parenthood
Federation and Jhpiego, an international non-profit health organization
affiliated with Johns Hopkins University ( -- on the
administration of the donation program.

    Led by Dr. Rengaswamy Sankaranarayanan of the International Agency for
Research on Cancer (IARC), the randomized, controlled trial compared the
efficacy of three methods of cervical cancer screening: VIA, Pap testing
(cytology) and HPV testing with QIAGEN's hybrid capture 2 (hc2) DNA testing
technology (called the digene HPV Test). The study was conducted in the
Maharashtra state of India, and was supported with funding by the Bill &
Melinda Gates Foundation.

    It is the first randomized controlled trial to measure incidence of
cervical cancer and associated rates of death as the primary outcomes, using
different tools for screening. In addition to being "associated with a
significant reduction in the numbers of advanced cervical cancers and deaths
from cervical cancer," QIAGEN's hc2 HPV testing platform "was the most
objective and reproducible of all cervical cancer screening tests and was
less demanding in terms of training and quality assurance," the study authors
state. The study is posted to

QIAGEN broadens access to HPV testing

    QIAGEN's donation of 1 million HPV tests builds upon the company's
programs to increase access to HPV testing and cervical cancer prevention
technologies for women worldwide through QIAGENcares, a corporate social
responsibility program to improve the access to better screening methods for
infectious diseases in emerging and developing countries. Current commitments
include donation programs, development of next generation HPV technologies,
tiered-pricing initiatives and on-the-ground pilot cervical cancer
screen-and-treat projects.

    To ensure that HPV testing can reach women in all regions of the world,
QIAGEN is working with PATH and the Bill & Melinda Gates Foundation to
develop a new version of its state-of-the-art HPV test -- to be called the
careHPV test -- for public-health programs in low-resource, developing
countries. The careHPV test, currently in development, can be performed
without electricity or running water and offers HPV detection results in a
matter of hours -- a critical characteristic for women traveling to clinics
from isolated villages and for those women who may need to be treated the
same day. Both QIAGEN HPV screening technologies -- careHPV and the digene
HPV Test -- are expected to play a key role in reducing cervical cancer
worldwide. Both will be included in the donation program.

    As part of its on-the-ground programs, QIAGEN is preparing to launch a
mobile cervical cancer screening clinic in India. India has more cervical
cancer cases than any other country in the world and cervical cancer is the
number one cause of cancer related death among women. Additionally, in China,
QIAGEN is providing HPV testing products to 29 hospitals as part of a
nationwide prevention campaign organized by the Cancer Foundation of China.
For more information on QIAGENcares and the donation program, visit

About the digene HPV test

    QIAGEN's digene HPV Test is approved in the United States and Europe for
use together with a Pap in women 30 and older. FDA-approved since 1999, the
digene HPV Test has been published in more than 300 peer-reviewed journal
articles and studied in clinical trials involving more than 825,000 women
worldwide. More than 40 million tests for carcinogenic HPV have been
performed with the digene HPV Test.

About HPV and cervical cancer

    Worldwide, cervical cancer affects approximately 500,000 women annually
and, after breast cancer, is the second-most-common malignancy found in
women. Since the cause of cervical cancer -- HPV -- is known and women who
have it can be identified, it is a highly preventable and treatable disease
if women have access to organized prevention programs. However, the World
Health Organization estimates that only about 5 percent of women in the
developing world have been screened for cervical disease in the previous five
years, compared to 40-50 percent in the developed world. For more information
about HPV and cervical cancer, visit


    QIAGEN N.V., a Netherlands holding company, is the leading global
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 one of
the broadest panels of molecular diagnostic tests available worldwide. This
panel includes the digene HPV Test, which is regarded as the "gold standard"
in testing for high-risk types of human papillomavirus (HPV), the primary
cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30
locations worldwide. Further information about QIAGEN can be found at


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