The US Food and Drug Administration (FDA) has secured approval to Teal Health’s at-home vaginal sample self-collection device, Teal Wand, for cervical cancer screening.
This prescription device claims to be the first and only product of its kind in the US, and will soon be available on the company’s website for those aged 25–65 at average risk of cervical cancer.
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It includes a collection kit and a telehealth service, offering virtual access to medical providers of the company who prescribe the kit, review laboratory results, and offer support throughout the screening process.
The device claims to enable women to self-test for HPV (human papillomavirus), the primary cause of cervical cancer, using Roche’s cobas HPV test, recommended by medical guidelines.
According to the company, women can send the self-collected sample to a certified laboratory for processing, offering the same accuracy as tests conducted in a clinical setting.
The FDA approval was based on the company’s SELF-CERV study, which confirmed that the Teal Wand’s self-collected samples match the performance of clinician-collected samples.
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By GlobalDataThe study, reflecting the diversity of the US population, claims to have shown a 96% detection rate for cervical precancer.
It also revealed a significant preference for at-home screening, with 86% of subjects more likely to stay current with their screenings if an at-home option were available, and 94% preferring the Teal Wand.
With this approval, the company is preparing to make the Teal Wand available as of next month, initially in California, with plans for a rapid countrywide expansion.
The company noted that it is collaborating with insurance providers and is planning to offer payment alternatives to make the device accessible and affordable.
Teal Health CEO and co-founder Kara Egan said: “As a mother and a woman, I get how easy it is to put your own health last. That’s why this FDA approval means so much; it’s not just about an innovative new product, it’s about finally giving women an option that makes sense for their lives – something that can be done quickly and comfortably at home.”
