The FDA recently approved a molecular HPV test for primary screening of cervical cancer, and now a broad-based group of medical professionals has issued interim guidance reinforcing the FDA decision. Published in the journal Gynecologic Oncology, the guidance states that using a high-risk human papillomavirus test alone for primary cervical cancer screening is an effective alternative to the current recommendation for screening with either cytology (the Pap test) alone or co-testing with cytology and HPV testing.
The recommendations are based in part on end-of-study results from the ATHENA trial, an examination of 42,000 women to evaluate cervical cancer screening algorithms, co-published in the same issue.
Join AACC for this FREE 60-minute webinar, supported by an educational grant from Roche Diagnostics. Dr. Mark Stoler, an ATHENA study principal, will explain what these new developments mean for women’s health care and help lab professionals navigate the changes in this dynamic area of cancer screening.
- Review of the end-of-study data that justifies these guidance recommendations
- Comparison of ATHENA to long term follow up studies performed outside the U.S.
- Compare the relative effectiveness of three different testing algorithms (cytology, hybrid co-testing and primary HPV with genotyping and reflex cytology)
- Relevance of primary screening with assays that can identify high-risk HPV types
Mark H. Stoler, MD, Professor (Emeritus) of Pathology, Cytology and Gynecology; and Director, Gynecological Pathology Fellowship Program, University of Virginia, Charlottesville, VA
Dr. Stoler is an internationally recognized expert in cytopathology, gynecologic pathology and HPV biology. He received his initial training in pathology at the University of Rochester where he also received his undergraduate and medical school training. Following a specialized fellowship consisting of both surgical and cytopathology as well as molecular biology, he was appointed to the faculty of the University of Rochester from 1985-1989. In 1989, he moved to the Cleveland Clinic Foundation where he served as Staff Pathologist and Medical Director of the Histology Laboratory. In 1993, Dr. Stoler was recruited to the University of Virginia.
Dr. Stoler is the author or co-author of over 177 peer-reviewed publications and several book chapters. He is editor-in-chief of both Diagnostic Molecular Pathology and the International Journal of Gynecological Pathology, and is an Associate Editor for the 4th Edition of Sternberg's Diagnostic Surgical Pathology, the leading textbook of surgical pathology.
Laboratory administrators, directors, and managers; cytopathologists and cytotechnologists; molecular pathologists; clinicians; and IVD industry professionals involved in cervical cancer screening or HPV testing.