First at-home test kit for cervical cancer approved by the FDA, company
says
[May 10, 2025]
WASHINGTON (AP) — 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 Friday 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.
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The U.S. Food and Drug Administration campus in Silver Spring, Md.,
is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
 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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