The FDA approved the first at-home screening test for cervical cancer on May 9, a move experts anticipate will help boost screening rates across the country.
Five notes:
1. The test kit is made by Teal Health. Using the kit, patients can self-collect a sample to test for human papillomavirus — which causes nearly all cervical cancers. The sample is then mailed to a lab for processing.
2. Patients can obtain a prescription for the at-home testing device through a telehealth appointment with Teal medical providers. Currently, the test kit must be prescribed by the company’s virtual providers, though it plans to enable outside physicians to prescribe the device, according to NBC News. When test results are positive, Teal Health providers help patients arrange further care.
3. Teal Health did not share information on the cost of the test kit. However, the company’s CEO Kara Egan told NBC she anticipates it will be covered by insurance, since cervical cancer screening is endorsed by the U.S. Preventive Services Task Force. The company anticipates it will have more information on insurance coverage in the next few months.
4. The approval follows updated draft screening guidance the USPSTF released in December, which recommended that women between the ages of 30 and 65 undergo HPV testing every five years. For the first time, the draft guidance stated women may self-collect vaginal samples for testing at their clinician’s office. Industry experts praised the recommendation, anticipating it will increase screening rates among patients who may be uncomfortable with Pap smears.
5. Cervical cancer is considered one of the most preventable and treatable cancers with routine screenings and the HPV vaccine. In the U.S., between 20% and 50% of women diagnosed with cervical cancer are not screened in the five years leading up to their diagnosis, according to the American Cancer Society. Studies have suggested that screening rates have fallen in recent years. One study published in JAMA Network Open found 23% of women were behind on their screenings in 2019, up from 14% in 2005.
