FDA Approves Teal Health's Teal Wand for At-Home Cervical Cancer Screening, Available in California for Ages 25-65

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Updated May 10, 2025, 01:10 AM

The U.S. Food and Drug Administration (FDA) has approved the first at-home cervical cancer screening test, the Teal Wand, developed by Teal Health. This test allows women aged 25 to 65 at average risk to collect their own vaginal samples to screen for human papillomavirus (HPV), the virus responsible for nearly all cervical cancers. Previously, HPV tests and Pap smears required an in-clinic visit, but the Teal Wand offers a new option for at-home screening. The device will be available starting in California in June, with plans to expand nationwide. A prescription is required, which can be obtained through a virtual visit with a Teal Health provider. The approval follows a study by Teal Health demonstrating that self-collected samples using the Teal Wand are as accurate as those collected by clinicians. Teal Health's study also found that 86% of participants would be more likely to stay up-to-date with cervical cancer screening if they could do it at home, and 94% preferred self-collection if they knew it was accurate. Teal Health is working with major insurance providers on coverage and flexible payment options. 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.' The Teal Wand collection kits will be tested at Clinical Laboratory Improvement Amendment-certified labs, with results available about one week after mailing samples in. Getting an HPV vaccine in adolescence can greatly reduce the risk of developing cervical cancer later in life.

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#FDA #Teal Wand #Teal Health #Pap #California #Kara Egan #Clinical Laboratory Improvement Amendment

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Sources

cbsnews.com(3)reuters.com(2)abc7chicago.com kens5.com

CBS News

@CBSNews

The maker of an at-home cervical cancer screening test said Friday it has won approval from the Food and Drug Administration, giving patients an alternative to in-clinic pap smears. https://t.co/sVn3WBMJfQ

ABC 7 Chicago

@ABC7Chicago

There's a new self-guided way to screen for cervical cancer at home that was approved by the FDA. But doctors caution that it's not for everyone. Here's what you need to know. https://t.co/GYadwNzPFs