US-based women’s health company Teal Health has secured the US Food and Drug Administration (FDA) approval for Teal Wand, an at-home self-collection device for cervical cancer screening.
Teal Wand, designed for women aged 25-65 at average risk, allows women to conduct screenings from home with accuracy comparable to clinical visits.
It offers a prescription-based service, including a collection kit and a telehealth service.
The service provides virtual access to Teal medical providers who prescribe the kit, review lab results, and offer support throughout the screening process.
The device tests for human papillomavirus (HPV), the virus responsible for nearly all cervical cancers, using the cobas HPV test from Roche.
Its sample collection method aligns with medical guidelines and offers an alternative to traditional Pap smears, providing higher sensitivity in identifying women at risk of cervical cancer.
It is the first at-home vaginal sample self-collection device for cervical cancer screening in the US, said Teal Wand.
Teal Health clinical, regulatory, and quality VP Trena Depel said: “The FDA prioritised the review of at-home self-collection, recognising its potential to increase cervical cancer screening adherence, as emphasised in the recent USPSTF (United States Preventive Services Task Force) draft guidelines.
“After awarding the Teal Wand Breakthrough Device Designation, the FDA stayed committed to a timely review, leading to approval of a technology that delivers meaningful performance, benefits, and choice.
“This isn’t just a win for Teal—it’s a win for every woman who deserves a rigorously tested and FDA-reviewed at-home cervical cancer screening option.”
The FDA approval follows the SELF-CERV study, which showed that self-collected samples using the Teal Wand perform as well as clinician-collected samples.
The study, reflecting the US population’s diversity, showed that 96% of cervical precancers were detected, with 86% of participants indicating a preference for at-home screening.
Teal Health plans to launch the Teal Wand kits starting in California in June, with a nationwide expansion to follow.
