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

Gaithersburg, Maryland and Hilden, Germany (ots/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 QAIGEN'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.

ots Originaltext: Qiagen N.V.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Pam Rasmussen, Vice President, Communications, Digene : A QIAGEN
Company, +1-240-506-0766, Pamela.Rasmussen@digene.com; Jennifer
Garratt, Burson-Marsteller UK, +44-7979-603236,
jennifer.garratt@bm.com


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