FDA Approval of Self-Collected HPV Testing: A New Era in Screening

According to the National Institutes of Health, almost 13,000 women in the United States are diagnosed with cervical cancer each year, resulting in around 4,000 deaths, with most of the deaths occurring among under-screened women. Now, there is potentially a barrier-breaker. As of August 15, 2024, self-collection kits for cervical cancer screening may be available in doctor's offices and other clinical sites, ready for use. The kits allow patients to collect their own vaginal sample for HPV testing in a health care setting, as an alternative to a Pap smear. The FDA approved the kits on May 15, 2024. This is different from the OTC at-home HPV test kits. The tests, which are FDA cleared, are not yet available for people to use at home. The FDA's approval of these tests aims to increase access to HPV screening and reduce barriers to sample collection. Roche and BD both plan to consider offering at-home options in the future. Although a variety of companies currently offer at-home HPV tests, the Food and Drug Administration (FDA) has not yet approved at-home HPV tests. Listen in to today’s episode for details.