FDA Approves First At-Home Cervical Cancer Screening Test

The Food and Drug Administration (FDA) has approved Teal Wand, an at-home cervical cancer screening test developed by Teal Health, a women's health company. This test offers an alternative to in-clinic Pap smears for individuals aged 25 to 65 at average risk. The Teal Wand screens for human papillomavirus (HPV), the primary cause of nearly all cervical cancers.
The approval is based on a company study that demonstrated self-collected samples using the Teal Wand are as accurate as those collected by clinicians. Traditional clinician-collected screenings involve using a speculum to open the vaginal canal, followed by a swab to collect a cell sample from the cervix. While Pap smears are a vital health screening tool, some individuals find the process uncomfortable, leading to avoidance of necessary medical visits and potential delays in early detection.
Teal Health's research indicated that 86% of participants believed they would be more consistent with cervical cancer screenings if they could perform them at home, and 94% preferred at-home self-collection given its accuracy. The at-home approval builds upon previous approval for self-collection in healthcare settings, aligning with similar approvals for other companies. Both self-collection methods provide the benefits of screening in a more accessible format for patients.
Kara Egan, CEO and co-founder of Teal Health, emphasized the significance of the FDA approval, stating, "As a mom 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 actually makes sense for their lives—something that can be done quickly and comfortably at home. Because when we make care easier to get, we help women stay healthy, for themselves and for the people who rely on them every day."
Teal Health plans to launch the kits for shipping in June, starting in California and expanding nationwide. The company is also collaborating with major insurance providers to offer flexible payment options.
It's important to note that getting an HPV vaccine in adolescence can significantly lower the risk of developing cervical cancer later in life.
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