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The Food and Drug Administration approved the first at-home test for cervical cancer screening in the US on Friday, offering an easily accessible alternative to the traditional pap smear.
The new test, created by Teal Health, provides the same accuracy testing for HPV — the virus that causes nearly all cervical cancers — without a painful pelvic exam at a doctor’s office.
Instead, the “Teal Wand” detects HPV using a vaginal swab, a far less invasive practice than the pap smear, during which a gynecologist uses a speculum to scrap cells off the cervix.
According to the company, women using the Teal Wand collect samples from home and send them to a certified lab for testing.
The FDA’s decision to approve the test was based on a study of more than 600 women that showed self-collected samples using its test had the same performance as samples collected by doctors, Teal said in a press release.
Teal’s new test 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 co-founder and CEO Kara Egan.
Each year in the US, some 11,500 cases of cervical cancer are diagnosed.
Cervical cancer is entirely preventable with regular screening, according to Teal. However, it still kills about 4,000 American women each year, according to the Centers for Disease Control and Prevention.
It was not immediately clear how much the test would cost. However, Teal said it was working with major insurance providers for coverage.
Teal plans to begin rolling out the kits for patients in California between the ages of 25 and 65 in June, before expanding nationwide.
With Reuters contributions
English (US) ·