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GAITHERSBURG, Maryland, Nov 07, 2006 (PR Newswire Europe via COMTEX) -- A large, long-term Danish Cancer Society study has found that for women age 40 and older, testing for human papillomavirus (HPV) is more effective in predicting cervical cancer risk than the traditionally used Pap smear. The study, which followed more than 10,000 women for 10 years, was published in the Nov. 1 issue of Cancer Research. To determine whether women in the study had HPV - the cause of cervical cancer - researchers used Digene Corp.'s Hybrid Capture 2 (hc2) High-Risk HPV DNA Test(TM). Digene's test is the only FDA-approved and CE-marked test for potentially cancer-causing types of HPV.
In a news release issued by the publisher of the journal, the American Association of Cancer Research (AACR), the senior author of the study, Susanne Kjaer, MD, stated, "We have documented that a single HPV test can actually predict older women at risk for cervical cancer better than a single Pap smear can. Based on these results, we feel that an HPV test would benefit older women, whether or not that test is used in conjunction with Pap smears or used by itself as an initial screen."
Dr. Kjaer and her colleagues concluded that while HPV infection in younger women is more frequent, it also is usually transient. In contrast, HPV infection in women age 40+ is less common but more persistent - putting them at higher risk of developing abnormal cells that can turn into cervical cancer if not detected and treated early. In the study, as many as 21 percent of older women whose Paps were initially normal but who were found to have HPV later developed significant abnormal cells on their cervix. In contrast, only 1.7 percent of women whose HPV and Pap tests were normal later developed abnormalities.
Pap smears (also referred to as cervical cytology) are done by examining a sample of cervical cells under a microscope to look for abnormalities. However, in spite of its long history of success as a cancer-screening tool, cytology "has important limitations," the researchers report. Pap testing "is only moderately accurate, and the average sensitivity to detect cervical cancer or pre-cancerous (cells) was considerably lower than generally believed." In contrast, the HPV DNA test detects the genetic presence of 13 types of high-risk HPV; no human interpretation is required.
"Since even a single, positive HPV test is substantially predictive of future cellular changes in the cervix, it can help stratify women into different risk categories," said Dr. Kjaer in the AACR announcement.
Worldwide, cervical cancer affects more than 400,000 women annually. After breast cancer, it is the second-most-common malignancy found in women.
CONTACT: Journalists may contact Pam Rasmussen, Tel. +1-301-944-7196, E-mail:
Pamela.Rasmussen@digene.com
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