Pathology Network

Skip Navigation Links
Home
BlogExpand Blog
Information and ServicesExpand Information and Services
Skip Navigation LinksHome > Blogs > Pⁿ Blog > FDA PULLS the HPV Trigger!
Pⁿ Blog
The Pⁿ Blog is a forum for opinions, questions, controversies, and instructive discussions across the field of pathology and its relevant subspecialties.
Monday, April 28, 2014
FDA PULLS the HPV Trigger!
In case you missed it, on April 24th the FDA approved the cobas human papillomavirus test, manufactured by Roche Molecular Systems, as a primary screen for cervical carcinoma.  The cobas HPV test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other high-risk HPVs.  Women who are negative with the cobas test to not require a Pap smear.  Women who test positive for HPV 16 or HPV 18 should have a colposcopy.  Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy.  Health care professionals are advised to use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.
 
Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use.
 
Although this may not be the death knell for the Pap test as a primary screen for low-risk patient populations, it is certainly a large step in that direction. 
About the Author

Stacey E. Mills, MD
Stacey E. Mills, MD, a graduate of University of Virginia (UVA) and the UVA Medical Center, has authored nearly 230 articles, 20+ books, atlases and monographs—including the renowned Sternberg's Diagnostic Surgical Pathology. He has been a practicing Professor and Staff Pathologist at UVA for 30+ years and is Director of Surgical Pathology and Cytopathology. His clinical specialty is general surgical pathology with emphasis on neoplasms and neoplasm-like lesions. Dr. Mills is also Editor-in-Chief of The American Journal of Surgical Pathology.