The United States Food and Drug Administration has approved the first at-home test for cervical cancer screening, Teal Health, which makes the test kit, said.
Currently, women have to visit the doctor for a Pap smear test to confirm the cancer diagnosis.
Teal Health plans to begin rolling out the kits in June for patients aged 25 to 65 years. The company said the FDA’s decision was based on a study of more than 600 women who showed self-collected samples using its test had the same performance as clinician-collected samples.
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Last year, the FDA gave the company’s Teal Wand “breakthrough device” status, allowing the agency to review it on a faster timeline.
Teal Wand will be available by prescription and will include an at-home self-collection kit. Women can self-collect samples using the device and mail them to the lab for HPV testing. Teal Health did not disclose the test’s price but said it was working with major insurance providers for coverage and flexible payment options.
The approval is “not just about an innovative new product; it’s about finally giving women an option that makes sense for their lives — something that can be done quickly and comfortably at home,” said Teal’s co-founder and CEO, Kara Egan.
