Previous test kits allowed women to collect their own samples but had to be performed at a health clinic.
WASHINGTON — U.S. regulators have given the green light to the first cervical cancer testing kit that enables women to gather their own sample at home and then send it to a lab, as announced by a medical device company.
According to Teal Health, the Food and Drug Administration has approved its Teal Wand for home usage. This device provides a novel method for collecting vaginal samples to identify the HPV virus, which is linked to cervical cancer. Traditionally, HPV tests and Pap smears are conducted at healthcare facilities or during visits to a doctor’s office.
An authoritative federal advisory committee last year endorsed the practice of self-collecting HPV samples to enhance screening rates. While the FDA recently broadened the application of two existing HPV tests for self-sampling, those still require administration in a medical office or mobile clinic setting.
HPV, or human papillomavirus, is very common and is spread through sex. Most HPV infections clear up on their own, but persistent infection can lead to cancer of the cervix. Most cervical cancers occur in women who are inadequately screened, diagnosed or treated.
To collect a sample, a swab or brush is inserted into the vagina and rotated, then the swab is put into a tube or container and processed at a lab.
Teal Health’s kit requires a prescription, which customers can obtain through one of the company’s online health providers. The San Francisco-based company said it will initially beginning selling the kits in California next month before expanding to other states. The company also said it is working with insurers on health coverage for the test.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Copyright 2025 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
