The first at-home screening kit for human papillomavirus, the leading cause of cervical cancer in the U.S., has been approved by the U.S. Food and Drug Administration.
The prescription device from Teal Health allows people to collect samples at home and send them off for lab testing. Teal Health connects each person with a health care provider before the test is shipped to their home address, and again after the sample has been collected, mailed to a lab and analyzed. The screening kit, called the Teal Wand, initially only will be available online in California, but Teal Health plans to expand access to other states.
The women's health company said the Teal Wand provides a more comfortable alternative to a traditional pap smear with the same accuracy.
A comparative study of more than 600 people across 16 U.S. trial sites found the kit correctly detected HPV when pre-cancer — abnormal cells more likely to develop into cancer — was present 96% of the time. Clinicians who collected samples reported the same accuracy rate. But 94% of women in the study preferred the Teal Wand over a pap smear, as long as the results were reliable.
The enthusiasm could translate into more consistent cervical cancer screenings. An 86% majority of the study participants said they would be more likely to test on time with a Teal Wand. Physicians generally recommend women ages 21 to 65 get a pap smear at least once every three years.
According to the Centers for Disease Prevention and Control, more than 9 in 10 of all cervical cancers in America are caused by HPV. Nearly 200,000 women in the U.S. are diagnosed with cervical pre-cancer each year. Over 10,000 women are diagnosed with cervical cancer annually, and about 4,000 die from it. Nearly all cervical cancers, the CDC advises, can be prevented by HPV vaccination.
The Teal Wand has been approved for people 25 to 65 with an average risk of cervical cancer. It is not recommended for anyone who is pregnant, has had treatment for cervical pre-cancer or has a history of cancer in the reproductive system, HIV, immunosuppression or diethylstilbestrol exposure. Teal Health says it expects to expand to more states soon.
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