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Screening guidelines support HPV testing.(human papillomavirus DNA testing)
2003 JAN 2 - (NewsRx.com & NewsRx.net) -- Digene Corporation (DIGE) announced that the American Cancer Society (ACS) has issued new cervical cancer screening guidelines including a preliminary recommendation that human papillomavirus (HPV) DNA testing for high-risk HPV types, together with a Pap test, be used in primary screening for women age 30 and over as frequently as every 3 years.
The ACS guidelines are published in the November/December 2002 issue of CA: A Cancer Journal for Clinicians and are the first revision to guidelines published in 1987. The guidelines are the first by a major medical group in the United States to advocate testing for HPV, the primary causal factor in the development of cervical cancer, in routine cervical cancer screening.
The ACS recommendations are conditioned upon FDA approval of HPV DNA testing for this purpose, and Digene has submitted data in a premarket approval supplement (PMAS) application to the FDA for this indication. Consistent with FDA recommendations specific to this application, the guidelines also state that further evidence of efficacy from follow-up studies is needed, as well as counseling and education related to HPV infection. Digene's Hybrid Capture 2 HPV DNA Test is the only FDA-approved test for HPV and is approved by the FDA for use as a follow-up to an abnormal Pap test result.
The new ACS guidelines state that "HPV DNA testing has greater sensitivity than cytology for detecting clinically relevant lesions" and that the "high negative predictive value resulting from concomitant screening with cytology and HPV DNA testing could safely permit increasing screening intervals, thus lowering costs." They also state "should the FDA approve HPV DNA testing for this purpose, it would be reasonable to consider that for women aged 30 and over, as an alternative to cervical cytology testing alone, cervical screening may be performed every 3 years using conventional or liquid-based cytology combined with a test for DNA from high-risk HPV types."
The ACS's recommendations ...
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Source: HighBeam Research, Screening guidelines support HPV testing.(human papillomavirus DNA...