The U.S. Food and Drug Administration (FDA) has approved the first at-home cervical smear device for screening for human papillomavirus (HPV) and cancer, Teal Health said in a press release.
Cervical cancer is a common (including among young women) malignant neoplasm, most often caused by certain types of human papillomavirus (HPV). It is one of the few cancers that is almost completely preventable through screening. For the past 80 years, the standard screening has been the Pap smear. It is performed by a doctor using a gynecological speculum and a cervical brush, the resulting smear is stained and examined under a microscope. Recently, microscopy has been replaced by the more sensitive primary HPV screening in a smear.
Despite the high effectiveness of screening, its coverage is declining, especially in developed countries. This is due to the difficulty of making and keeping appointments with doctors, as well as the discomfort associated with the procedure. In 2024, the FDA approved two devices from BD and Roche that aim to address the latter issue by allowing women to take a swab themselves, but in a health care setting.
The Teal Wand kit is designed for self-collection of cervical smears at home by women aged 25–65 years with an average risk of cervical cancer. It includes a sponge swab with a guide for collecting the smear itself (the manufacturer claims that using it is no more difficult than a regular sanitary swab) and a container for sending the sample to an affiliated lab, where it is analyzed by the Roche cobas HPV clinical diagnostic system. The kit is integrated with a telemedicine service that provides access to a Teal doctor, who prescribes the kit (it is available by prescription only), instructs the woman on the smear collection process, interprets the results from the lab, and advises on further actions.
The FDA's decision was prompted by the results of the SELF-CERV clinical trial, which involved more than 600 women in 16 U.S. locations. They confirmed that smears taken with the Teal Wand were as effective as those taken by a specialist in terms of diagnostic efficiency, detecting precancerous changes in the cervix in 96 percent of cases. In addition, 94 percent of participants said they would prefer to take a smear at home if they were confident in its effectiveness, and 86 percent said they would be much more likely to undergo screening on time if they were taken at home.
Teal Wand kits are expected to be available in California as early as June 2025, with other U.S. states to follow soon after. No price has been announced yet, but Teal is working with all major health insurance companies to make the service as affordable as possible.
Previously, the FDA licensed over-the-counter tests for self-diagnosis of chlamydia, gonorrhea, and trichomoniasis using a vaginal swab in women and syphilis using a drop of blood from a finger in men and women.
