FDA approves use of self-collected specimens for HPV testing

Key takeaways:

• The FDA approved expanded indications for the self-collection of vaginal swabs for HPV tests.
• The approval will expand cervical cancer screening options for patients.

The FDA approved expanded indications for two HPV tests allowing for the patient to self-collect a vaginal swab in a health care setting when it is not possible for the clinician to collect a cervical specimen, according to a press release.

The tests, the OnClarity HPV assay (Beckon, Dickinson and Co.) and the Cobas HPV test (Roche Molecular Systems) were each previously approved for cervical cancer screening through the detection of HPV in cervical specimens collected in a health care setting by a clinician. The approvals for use of self-collected vaginal specimens are part of a larger FDA effort to expand cervical cancer screening options for patients, according to the agency.

“Many patients are uncomfortable with the intimate nature of a pelvic exam,” Jeff Andrews, MD, FRCSC, vice president of global medical affairs for diagnostic solutions at BD, said in a press release. “Also, many people live in areas without a local doctor or clinician trained to obtain a sample with a speculum. The option to self-collect in a clinical setting can help a women overcome some of these barriers.”

As Healio previously reported, cervical cancer incidence and mortality among women living in America’s lowest-income counties is rising, according to a recent study. Yet, cervical cancer is largely preventable through vaccination against HPV, as well as through screening for early detection and treatment of precancerous lesions.

“With vaccinations, innovative diagnostic tools and screening programs, achieving WHO’s goal of eliminating cervical cancer by 2030 is within reach,” Matt Sause, CEO of Roche, said in a press release. “Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing.”

Roche collaborated with the National Cancer Institute on the Cervical Cancer “Last Mile” Initiative. The public-private partnership has helped facilitate the regulatory pathway toward approval, according to the company.

References:

BD. Women in U.S. Can Now Collect Their Own Sample for Cervical Cancer Screening. Available at: https://news.bd.com/2024-05-15-Women-in-U-S-Can-Now-Collect-Their-Own-Sample-for-Cervical-Cancer-Screening. Accessed: May 21, 2024.

FDA Roundup: May 17, 2024. Available at: https://www.fda.gov/news-events/press-announcements/fda-roundup-may-17-2024. Accessed: May 21, 2024.