New clinical practice guidelines, published in a recent issue of the Journal of the American Medical Association (287:2120-2129, 2002), recommend that women who receive borderline Papanicolaou (Pap) test results designated as atypical squamous cells of undetermined significance (ASCUS)-a finding in more than 2 million American women each year-undergo testing for human papillomavirus (HPV). In clinical studies, HPV has been shown to be the primary causal factor in the development of cervical cancer.
New clinical practice guidelines, published in a recentissue of the Journal of the American Medical Association (287:2120-2129, 2002),recommend that women who receive borderline Papanicolaou (Pap) test resultsdesignated as atypical squamous cells of undetermined significance (ASCUS)afinding in more than 2 million American women each yearundergo testingfor human papillomavirus (HPV). In clinical studies, HPV has been shown to bethe primary causal factor in the development of cervical cancer.
The new "2001 Consensus Guidelines" were sponsored by the AmericanSociety for Colposcopy and Cervical Pathology (ASCCP) and developed with inputfrom 29 medical organizations, including the National Cancer Institute, theCenters for Disease Control and Prevention, and the American Cancer Society.They represent the first evidence-based, national practice guidelines to offerdoctors, nurses, and other clinicians direction in the management of women withabnormal Pap test results.
The Preferred Approach
The new consensus guidelines state that HPV testing is the preferred approachto the management of women with ASCUS Pap results, when it can be performeddirectly from a liquid-based Pap test ("reflex" HPV testing) or whenthe HPV test specimen can be collected during the initial office visit.According to the consensus guidelines, "Reflex HPV DNA testing offerssignificant advantages since women do not need an additional clinicalexamination for specimen collection, and 40% to 60% of women will be spared acolposcopic examination. Moreover, women testing negative for HPV DNA canrapidly be assured that they do not have a significant lesion."
Digene Corporation’s Hybrid Capture 2 (hc2) assay has been approved by theFDA to test for HPV. This HPV test can be performed directly from CytycCorporation’s Thin Prep Pap Test, a liquid-based replacement for theconventional Pap test.
Evan Jones, chairman and chief executive officer of the Digene Corporation,said, "These consensus guidelines are a significant new milestone for HPVtesting and cervical cancer screening. They were developed with input from manyof the country’s leading medical organizations involved in women’s healthcare and are based on the most recent clinical data demonstrating theeffectiveness of HPV testing in cervical cancer screening. We believe these newguidelines will further increase adoption of our hc2 HPV test, making it thestandard of care and ensuring that more women have access to the most advancedcervical cancer screening technology available."
The ALTS Study
Results from the National Cancer Institute’s ASCUS/LSIL (low-grade squamousintraepithelial lesion) Triage Study (ALTS), published in the Journal of theNational Cancer Institute (93:293-299, 2001), confirmed that HPV testing is themost effective way to manage women with ASCUS Pap results.
"Borderline Pap test results have traditionally been very frustratingfor both physicians and patients because there was no clear direction on how tomanage these women," said Dr. Diane McGrory, a gynecologist with GynecologyPartners in Weston, Mass. "By testing for HPV, a physician can betterdetermine which patients should have a colposcopy and which patients can besafely returned to normal screening. While many physicians are already using HPVtesting, the new consensus guidelines should help establish it as the standardof care."
Faster, More Accurate Answers
According to Linda Alexander, Digene’s vice president of Women’s Health,"The new consensus guidelines are a major step forward for women’shealth. By directing clinicians to use HPV testing to clarify borderline Paptest results, they can help women obtain faster, more accurate answers abouttheir current risk of cervical disease or cervical cancer. This can help reduceanxiety for women, while potentially helping them avoid unnecessary, invasive,and costly procedures."
The new consensus guidelines also recommend HPV testing to confirm theabsence of cervical disease and cervical cancer in women with a normalcolposcopy following Pap test results indicating ASCUS or low-grade cervicaldisease.