The Food and Drug Administration has approved the first at-home, vaginal-sample self-collection device for cervical cancer screening, according to a press release from the device manufacturer, Teal Health. As an alternative to in-office sampling and screening, the home collection method also includes virtual access to providers who prescribe the sample-collection kit, review the results from the lab, and answer patient questions. After the patient receives the at-home kit and collects the samples using a wand that resembles a tampon, she mails them to a lab where they are tested for human papillomavirus (HPV) using the same primary testing that is used for in-office samples. In U.S. studies at 16 sites with more than 600 participants, self-collected samples demonstrated the same performance as clinician-collected samples with 96% sensitivity, according to the manufacturer. Kits will be available starting next month in California followed by a nationwide launch.
Best practice update: In the 1940s, Georgios Papanicolaou, PhD, a Greek immigrant who worked at Cornell University and the University of Miami, published a book explaining cellular abnormalities that could be cancerous and described a method for collecting and testing vaginal and cervical smears. Within a decade, annual screenings ultimately known as “Pap smears” began, and the cervical cancer rate in the United States dropped dramatically. The Pap smear is no longer recommended as an annual exam as it once was, but updated best practices from the American College of Physicians in 2015 indicate testing every 3-5 years, based on risk.