American women will soon have a new option to screen for cervical cancer from the privacy of their homes.
The Food and Drug Administration has approved the first at-home self-collection test kit for detecting HPV, the virus that causes nearly all cases of cervical cancer, according to an announcement from the device maker Teal Health.
The product, known as the Teal Wand, allows women to collect their own vaginal sample at home using a brush or swab, which is then mailed to a laboratory for analysis. The company says the test has demonstrated a 96% accuracy rate in detecting cervical precancers, based on results from a clinical trial involving over 600 women.
Traditionally, cervical cancer screening is conducted through Pap smears or HPV tests performed by medical professionals during clinic visits. The Teal Wand is the first approved device that gives women the ability to collect the sample themselves without needing to visit a clinic or doctor’s office. The kit, however, does require a prescription, which can be obtained online through Teal Health’s telehealth platform.
The new testing method could help reach women who avoid or delay screenings due to discomfort, inconvenience, or lack of access to care. In the clinical trial, more than 90% of participants said they would prefer to use a home test if the results were reliable, and over 85% reported they would be more likely to follow through with recommended screenings if they could self-collect at home.
Cervical cancer remains a preventable disease, yet the Centers for Disease Control and Prevention reports that roughly 11,500 women are diagnosed annually in the United States, with around 4,000 deaths. Most cases develop in women who have not been properly screened or treated for persistent HPV infection.
The at-home kit is expected to become available in California starting in June, with plans to expand nationwide. Teal Health also said it is in discussions with insurance companies and will offer flexible payment options to help make the test widely accessible. Women between the ages of 25 and 65 who are at average risk for cervical cancer will be eligible to order the kit through the company’s website.
If a test result returns positive for HPV, the individual will be referred for a follow-up Pap smear. Those who test negative may not need to screen again for three to five years, depending on medical guidance.
Medical experts involved in the trial praised the approval, calling it a critical step toward increasing screening rates without compromising accuracy. They noted that the ability to self-collect samples could be particularly valuable for women in rural areas or those with limited access to healthcare providers.
The Teal Wand’s approval also follows recent support from federal health advisors who have recommended expanding self-collection options to boost cervical cancer screening and detection.