No doctor is needed.
For the first time, U.S. regulators have authorized a cervical cancer screening kit that allows women to collect their own samples at home and send them to a lab for analysis, according to medical device developer Teal Health.
The San Francisco-based company announced Friday that the Food and Drug Administration has approved its Teal Wand for home use. The device enables women to gather vaginal samples to test for HPV, the virus responsible for most cases of cervical cancer. Until now, such testing—including both HPV screenings and Pap smears—had to be done during an in-office medical visit.
Last year, a key federal advisory group encouraged broader use of self-collected HPV samples to improve screening rates, particularly among those who may avoid traditional exams. While the FDA recently extended the approval of two established HPV tests for self-collection, those are still limited to use in clinics or mobile units—not at home.
HPV (human papillomavirus) is a widespread sexually transmitted infection. While many cases resolve naturally, persistent HPV infections can lead to the development of cervical cancer. Most cervical cancer cases are linked to gaps in screening, diagnosis, or treatment.
Using the at-home kit involves inserting a brush or swab into the vagina, rotating it to collect a sample, and then placing it into a secure container for lab testing.
A prescription is required to use the Teal Wand, which users can obtain through the company’s affiliated online healthcare providers. Teal Health plans to roll out the test in California starting next month, with plans to expand nationally. The company also noted ongoing efforts to collaborate with insurers to provide coverage for the new screening option.
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