FDA approves first at-home HPV test: A breakthrough in cervical cancer screening

The U.S. Food and Drug Administration (FDA) has taken a historic step in approving the first human papillomavirus (HPV) screening test for home use, Teal Health, the product's manufacturer, announced Friday.

The device, dubbed the "Teal Wand," could revolutionize cervical cancer screening by offering a practical and affordable alternative to the traditional Pap smear recommended every three years for women up to age 65.

The device, manufactured by Teal Health in San Francisco, allows women to collect a vaginal sample in the privacy of their home and mail it to a laboratory for analysis.

Cervical cancer facts

The test is designed to detect HPV, the virus responsible for nearly all cases of cervical cancer. According to the Centers for Disease Control and Prevention (CDC), approximately 11,500 new cases of cervical cancer each year, and the disease causes about 4,000 deaths annually.

The FDA approval is based on a clinical trial involving more than 600 women, where the device demonstrated 96% accuracy in detecting cervical precancers.

The study also revealed strong support among participants: 86% indicated that they would be more willing to comply with screening recommendations if they could perform the test at home, and 94% expressed a preference for self-collection as long as the results were accurate.

A breakthrough to overcome barriers

Dr. Christine Conageski, associate professor of gynecology and obstetrics at the University of Colorado and director of the Complex Dysplasia Clinic, who led the SELF-CERV clinical trial, stressed the importance of this approval:

"Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward. ... It offers an evidence-based way to expand access without compromising accuracy," she said.

Dr. Ami Vaidya, co-director of gynecologic oncology at the John Theurer Cancer Center at Hackensack University Medical Center, noted that many women avoid the Pap test because of fears or discomfort. "Some women are scared of a traditional Pap smear or find the process uncomfortable — as a result, they put off this vital test."

How the device will work

Beginning in June, women between the ages of 25 and 65 at average risk for cervical cancer will be able to order the kit starting in California and with plans to expand nationally as soon as possible.

The product includes not only the self-collection device, but also a telehealth service with support from medical professionals throughout the process.

If the test detects HPV, women will be referred for a traditional Pap smear.

Those with negative results will not need to repeat the test for three to five years, according to screening guidelines. The company is also working with insurers to offer flexible payment options, seeking to reduce financial barriers and ensure broad access to this alternative.

A step toward prevention

The approval marks a milestone in the fight against cervical cancer, combining technological innovation with a focus on convenience and accessibility for women.