For the past 50 years, the Pap smear has dominated as a successful tool in screening for cervical cancer. Clinicians, pathologists, and laboratorians, however, “are approaching a tipping point for changing how we screen” for this disease, says Mark H. Stoler, MD, who recently explored this topic in a free AACC webcast. Stoler is a professor emeritus of pathology and clinical gynecology at the University of Virginia Health System and director of the University of Virginia’s Gynecological Pathology Fellowship Program in Charlottesville, Virginia. The webinar was supported by an educational grant from Roche. An archive of the session will remain available online for an extended period.
New developments in molecular screening are revolutionizing the way clinicians approach cervical cancer screening. Case in point: the Food and Drug Administration’s (FDA’s) first-time approval of an HPV DNA testing algorithm for women ages 25 and older to screen for cervical cancer. This is a measure that’s likely to affect future guidance. FDA based its decision on new data from the Addressing the Need for Advanced HPV Diagnostics (ATHENA) clinical trial.
During his webinar, Stoler reviewed the importance of clinical validity in assessing HPV tests and also held a discussion on the ATHENA clinical trial that prompted the FDA’s approval of the HPV DNA testing algorithm as a primary screen for cervical cancer for women above age 25.
A critical question for practices is whether this primary screening algorithm is an acceptable alternative to current screening methods recommended by practice guidelines, Stoler said. “What are the trade-offs? Why indeed are there no current guidelines that support primary screening?”
Laboratorians, in the meantime, need to be aware of the ATHENA trial data. Given the data, they have to decide whether to support their clinicians' choice of algorithm, and “what it might take to provide primary screening as a laboratory service,” he said.
AACC’s free webcast has been archived for further viewing.