FDA approves first at-home HPV test to screen for cervical cancer

The Food and Drug Administration (FDA) has approved the first at-home screening test for cervical cancer, offering women a convenient and potentially life-saving alternative to traditional Pap smears. The DIY test, known as the Teal Wand, allows women to collect a sample at home and mail it in for laboratory analysis.

The Teal Wand is designed to detect human papillomavirus (HPV), the virus responsible for almost all cases of cervical cancer. A recent clinical trial involving over 600 women found that the Teal Wand had a 96% accuracy rate in detecting cervical precancers. Additionally, 86% of participants expressed a preference for at-home screening, citing increased likelihood of compliance with screening recommendations.

Dr. Christine Conageski, an associate professor of OB-GYN and director of the Complex Dysplasia Clinic at the University of Colorado, lauded the FDA approval of the Teal Wand as a critical step forward in expanding access to cervical cancer screening. With approximately 11,500 new cervical cancer diagnoses and 4,000 deaths annually in the U.S., the availability of an at-home screening option could help improve early detection and save lives.

Women between the ages of 25 and 65 who are at average risk of cervical cancer will soon be able to order the at-home test through www.getteal.com. The kits are expected to be available in California starting in June, with plans for nationwide expansion. Teal Health is also working with major insurance providers to offer flexible payment options, ensuring that financial concerns do not prevent women from accessing this important screening tool.

In addition to the collection kit, the Teal Wand includes a telehealth service with support from medical providers throughout the screening process. Women who test positive for HPV will be referred for a traditional Pap smear, while those who test negative can wait three to five years before screening again.

Dr. Ami Vaidya, co-chief of gynecologic oncology at Hackensack University Medical Center’s John Theurer Cancer Center, emphasized the importance of making cervical cancer screening more accessible and comfortable for women. She stated that any test that helps detect cervical cancer is a win, especially for those who may be hesitant to undergo a traditional Pap smear.

Overall, the approval of the Teal Wand represents a significant advancement in cervical cancer detection and prevention. By offering women a convenient and accurate at-home screening option, the Teal Wand has the potential to increase screening rates and ultimately save lives.