NEJM Report Finds HPV Test More Effective Than Pap in Determining Cervical Cancer Risk

NEJM Report Finds HPV Test More Effective Than Pap in Determining Cervical Cancer Risk

October 18, 2007

    GAITHERSBURG, Md. and HILDEN, Germany, Oct. 18
/Xinhua-PRNewswire/-- The first randomized, controlled
study in North America of HPV testing as a stand-alone
screen concluded that it is almost 40 percent more accurate
than traditional cytology (the Pap "smear") in
identifying women with advanced cervical disease, according
to a report published today in The New England Journal of
Medicine.

    The study, which involved more than 10,000 Canadian
women age 30-69, found that the HPV test's sensitivity --
its ability to accurately identify women with pre-cancerous
cervical cells or cancer -- was 94.6 percent, compared to
55.4 percent for the Pap. HPV (humanpapilloma virus) is the
primary cause of cervical cancer.

    This seminal study used QIAGEN's Hybrid Capture(R) 2
High-Risk HPV DNA test -- the only such test that is both
CE-marked in Europe and approved by the U.S. Food and Drug
Administration(1). The molecular diagnostic test was
developed by Digene Corp., now part of QIAGEN N.V. (Nasdaq:
QGEN; Frankfurt, Prime Standard: QIA). The performance of
QIAGEN's HPV test has been validated in studies that
included more than 300,000 women.

    "We already knew before conducting this study that
the sensitivity of the Pap left a lot to be desired,"
stated one of the study's authors, Eduardo Franco, DrPH, of
Montreal's McGill University, in a news announcement.
"However, 55.4 percent accuracy is only slightly above
chance. Flipping a coin gives you 50 percent."

    Participants in the Canadian Cervical Cancer Screening
Trial (CCCaST) were randomly assigned to a "focus on
Pap" or "focus on HPV" screening group,
although for ethical reasons, both groups received both
tests. In this study, conventional cytology was used.
Recent analyses have found that the newer
"liquid-based" cytology does not significantly
improve the ability to detect disease. All CCCaST
participants who tested positive on either the Pap or HPV
test were referred for a follow-up biopsy. In addition to
the HPV test's greater sensitivity, the study found that
its specificity -- the likelihood that women with positive
results actually have disease -- was only slightly less
than the Pap's (94.1 percent vs. 96.8 percent).

    HPV testing for routine cervical cancer prevention is
currently most widely practiced in the United States, where
it is approved for use along with a Pap in women age 30 and
over. Under the currently recommended guidelines, screening
that includes HPV testing may be performed at longer
intervals than when the Pap is used alone. However, the
authors of the NEJM report concluded that co-testing
"only marginally improved sensitivity compared with
HPV testing alone."

    The conclusions of CCCaST reinforce a growing number of
other studies showing greater sensitivity for HPV testing
and suggesting its use as the primary, front-line screen --
with the Pap reserved for follow-up evaluation.  (2) For
example, most recently, the Oct. 4 issue of The Lancet
reported on a trial involving more than 17,000 women in the
Netherlands. The study, led by Professor Chris Meijer of VU
Medical Centre in Amsterdam, concluded that HPV DNA testing
detects pre-cancerous cervical cells earlier than the
traditional Pap, thus allowing longer intervals between
screenings. This is an important feature for health
authorities working to control costs -- particularly those
in developing countries, where a variety of obstacles make
it difficult for women to access regular medical care.

    Medical experts agree that the most effective approach
to cervical cancer prevention combines HPV vaccines for
girls and young women with screening of older women.

    "We believe that a shift from cellular to viral
(screening) tests, coupled with education and vaccination,
will contribute to more efficient control of cervical
cancer," the authors stated in the NEJM report.

    About HPV and cervical cancer

    Worldwide, cervical cancer affects more than 400,000
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.

    About QIAGEN

    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 QIAGEN can be found at
http://www.qiagen.com . Further information about HPV DNA
testing can  be found at http://www.theHPVtest.com .

    (1) The hc2 High Risk HPV test has been approved by the
Food and Drug 
        Administration for the follow-up evaluation of
women with ASC-US 
        (inconclusive) cytology and for use as an
adjunctive test combined 
        with the Pap to screen women age 30 years and
older.

    (2) This information is provided as a summary of
several clinical 
        studies. The use of the Hybrid Capture(R) High-Risk
HPV DNA Test as 
        a stand-alone screen for cervical cancer has not
been approved by 
        the U.S.Food and Drug Administration.


    For more information, please contact:

     Pam Rasmussen, Vice President
     Communications, Digene, A QIAGEN Company
     Tel:   [phone]
     Email: [e-mail]

     Jennifer Garratt
     Burson-Marsteller UK
     Tel:   [phone]
     Email: [e-mail]