The FDA has expanded approvals for two tests detecting cancer-causing HPV in the cervix, allowing self-collection of vaginal samples in healthcare settings like primary care offices, pharmacies, and mobile clinics. Previously, cervical cancer screening in the U.S. required samples collected via pelvic exams by healthcare professionals. The newly approved tests—Onclarity HPV and cobas HPV—are expected to increase access to screening, particularly for populations with historically low screening rates. According to Dr. Vikrant Sahasrabuddhe of NCI, these approvals are just the beginning, with more likely to follow, especially through the NCI-led “Last Mile” Initiative, which is accelerating the development of self-collection methods, including at-home testing.
A nationwide clinical trial, SHIP (Self-collection for HPV testing to Improve Cervical Cancer Prevention), will evaluate the effectiveness of home-based self-collection compared to clinician-collected samples. This initiative aims to reach underserved populations at high risk for cervical cancer.
Despite these advances, nearly 30% of eligible individuals in the U.S. don’t receive recommended cervical cancer screenings, contributing to about 11,500 new cases annually. Barriers include lack of access to healthcare providers and personal or cultural factors. The FDA’s approval of self-collection is a significant step, but Dr. Nicolas Wentzensen of NCI emphasizes that screening is just one part of a broader prevention strategy, which also requires follow-up care for positive results.