The FDA has approved the first at-home test for cervical cancer screening, developed by Teal Health, as an alternative to traditional smear tests conducted in clinics. This approval comes after a study involving over 600 women showed that self-collected samples using Teal’s test performed as well as clinician-collected samples. Teal’s co-founder and CEO, Kara Egan, emphasized that this approval is a significant step towards providing women with a more convenient and comfortable screening option that fits into their lives.

Cervical cancer remains a pressing issue in the US, with around 11,500 new cases diagnosed each year and about 4,000 women succumbing to the disease. Teal’s at-home test, named Teal Wand, detects the presence of human papillomavirus (HPV), the primary cause of cervical cancer. Unlike Roche’s cobas HPV test, which is designed for clinic use, Teal Wand allows women to collect samples at home and send them to a certified lab for testing.

Teal Health is working with major insurance providers to secure coverage and flexible payment options for the test. Drawing parallels with Exact Sciences’ at-home colon cancer test, Cologuard, which costs around $600, Egan expressed Teal Health’s commitment to offering their test at a more affordable price point. The company plans to introduce the kits starting in June for individuals aged 25 to 65, marking a significant advancement in accessible and proactive cervical cancer screening.