WASHINGTON (AP) — U.S. regulators have given the green light to the first home cervical cancer testing kit that allows women to collect their own sample and send it to a lab, as announced by medical device company Teal Health. The Food and Drug Administration has approved Teal Health’s Teal Wand for at-home use, providing a convenient method for detecting the HPV virus that can lead to cervical cancer. Currently, HPV tests and Pap smears are typically done at healthcare facilities or doctor’s offices.
Last year, a federal panel recommended self-collection of HPV samples to enhance screening efforts. The FDA has also recently expanded the use of two existing HPV tests for self-collection, although these still need to be carried out at a medical facility or mobile clinic.
HPV, or human papillomavirus, is a common sexually transmitted infection. While most HPV infections resolve on their own, persistent infection can increase the risk of cervical cancer. The majority of cervical cancers occur in women who have not been adequately screened, diagnosed, or treated.
To collect a sample, a swab or brush is inserted into the vagina, rotated, and then placed in a tube or container for processing at a laboratory.
Teal Health’s kit requires a prescription, which can be obtained through the company’s online health providers. The San Francisco-based company plans to launch sales of the kits in California next month before expanding to other states. Teal Health is also collaborating with insurers to secure health coverage for the test.
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