CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Recommended Reading
Christopher J. VandenBussche, MD, PhD
January 2020—The authors of an article published in the Journal of the American Society of Cytopathology participated in a public hearing at the Food and Drug Administration in January 2018. The hearing advised the FDA about what research would be required to demonstrate the safety and efficacy of a self-collected Papanicolaou test device. In the article, Staats, et al., review the literature on self-collected Pap tests. The authors also provide a review of published studies on self-collected HPV tests. They pose important questions that surround the self-collected Pap test; most remain only partially answered, given the limited evidence examining such tests in the literature (Staats PN, et al. Self-collected Papanicolaou tests in the United States market: more questions than answers. J Am Soc Cytopathol. 2019;8[6]:342–351).
A large body of observational data supports the effectiveness of the Papanicolaou test in reducing mortality from cervical cancer, yet over the past five years, eight million women ages 21 to 65, in the U.S. alone, were not screened for cervical cancer. Among the reasons are a lack of access, fear, and embarrassment. Women participating in self-collection studies often find self-collection to be more convenient, less uncomfortable, and less embarrassing than provider collection. For these reasons, even women who undergo regular screening may opt for self-collection over provider collection, should an FDA-approved self-collected Pap test become available.