In a significant advancement for women’s healthcare, Teal Health has received FDA approval for the Teal Wand™, the first at-home, self-collection device for cervical cancer screening in the United States. Designed to address the discomfort and barriers that often deter women aged 25 to 65 from undergoing routine cervical screenings, the Teal Wand offers a more comfortable, accessible, and private alternative to in-person smears and tests: a crucial step in detecting cervical cancer early, when it is most preventable.
The Teal Wand utilizes the same FDA-approved HPV test employed in clinical settings, ensuring similar accuracy in detecting high-risk human papillomavirus (HPV), the primary cause of cervical cancer. Clinical studies, including the SELF-CERV trial involving over 600 participants, reported a 96% detection rate for cervical precancer, underscoring the reliability of self-collected samples compared to clinician-collected ones.
One of the key motivations behind the development of the Teal Wand is to address barriers to screening that prevent many women from undergoing regular cervical cancer checks. According to Teal Health, 94% of participants in the trial expressed a preference for the at-home method over traditional in-clinic procedures, and 86% indicated they would be more likely to stay up-to-date with screenings if they could perform them at home.
The self-collection process involves a brief virtual consultation with a healthcare provider through Teal Health’s platform. Eligible individuals receive the collection kit by mail, gather their sample, and send it to a certified lab for analysis. Results are delivered through a secure online portal, with follow-up care provided as needed.
Teal Health is set to launch the Teal Wand in California in June 2025, with plans to expand its availability nationwide. The company is also working with insurance providers to secure coverage and provide affordable payment options, aiming to make cervical cancer screening more inclusive and accessible to underserved populations.
The FDA approval of the Teal Wand is not only a milestone for Teal Health but also a broader advancement in the effort to modernize cervical cancer screening methods. By offering a private, convenient, and clinically validated alternative to in-person screenings, Teal Health aims to increase screening rates, improve early detection, and ultimately reduce cervical cancer mortality rates in the United States.
