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 yearundergo testing for human papillomavirus (HPV). In clinical studies, HPV has been shown to be the primary causal factor in the development of cervical cancer.
The new "2001 Consensus Guidelines" were sponsored by the American Society for Colposcopy and Cervical Pathology (ASCCP) and developed with input from 29 medical organizations, including the National Cancer Institute, the Centers for Disease Control and Prevention, and the American Cancer Society. They represent the first evidence-based, national practice guidelines to offer doctors, nurses, and other clinicians direction in the management of women with abnormal Pap test results.
The Preferred Approach
The new consensus guidelines state that HPV testing is the preferred approach to the management of women with ASCUS Pap results, when it can be performed directly from a liquid-based Pap test ("reflex" HPV testing) or when the HPV test specimen can be collected during the initial office visit. According to the consensus guidelines, "Reflex HPV DNA testing offers significant advantages since women do not need an additional clinical examination for specimen collection, and 40% to 60% of women will be spared a colposcopic examination. Moreover, women testing negative for HPV DNA can rapidly be assured that they do not have a significant lesion."
Digene Corporation’s Hybrid Capture 2 (hc2) assay has been approved by the FDA to test for HPV. This HPV test can be performed directly from Cytyc Corporation’s Thin Prep Pap Test, a liquid-based replacement for the conventional Pap test.
Evan Jones, chairman and chief executive officer of the Digene Corporation, said, "These consensus guidelines are a significant new milestone for HPV testing and cervical cancer screening. They were developed with input from many of the country’s leading medical organizations involved in women’s health care and are based on the most recent clinical data demonstrating the effectiveness of HPV testing in cervical cancer screening. We believe these new guidelines will further increase adoption of our hc2 HPV test, making it the standard of care and ensuring that more women have access to the most advanced cervical cancer screening technology available."
The ALTS Study