First at-home test kit for cervical cancer approved by FDA, company says
U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company.
Teal Health said the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal samples that can detect the HPV virus that causes cervical cancer. Currently, HPV tests and Pap smears are performed at a health clinic or doctor's office.
An influential federal panel recommended last year the use of self-collection of HPV samples to boost screening. The FDA also recently expanded the use of two older HPV tests for self-collection, but those must be done at a medical office or mobile clinic.
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.
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