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

    GAITHERSBURG, Maryland and HILDEN, Germany, October 18 /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. ( 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.
 
 

SOURCE QIAGEN N.V.