The Food and Drug Administration (FDA) has given its approval for the first at-home cervical cancer screening test, as announced by the product’s manufacturer on Friday.
These do-it-yourself tests might be a viable alternative to the traditional PAP smears, which are recommended every three years for women up to 65 years old.
The self-collection device, created by Teal Health in San Francisco, is called Teal Wands. It allows women to collect samples and send them for lab analysis.
The primary goal of the test is to identify human papillomavirus (HPV), which is responsible for nearly all cases of cervical cancer.
The FDA’s approval followed a clinical trial that involved over 600 women, demonstrating a detection accuracy rate of 96% for precervical syndrome using the teal wands.
In this study, about 86% of participants expressed that they would likely follow cervical cancer screening recommendations if it could be done at home, according to Teal Health. Furthermore, 94% preferred self-collection at home, assuming the results were reliable.
“While cervical cancer is largely preventable, screening rates in the U.S. continue to lag behind. The FDA’s approval of this home self-collecting device is a significant step,” a health expert noted in a statement, highlighting its evidence-based approach to extending access without sacrificing accuracy.
Yearly, around 11,500 new cervical cancer cases are diagnosed, leading to about 4,000 deaths, as stated by the Centers for Disease Control and Prevention. Experts suggest that in addition to the risk of cervical cancer, HPV can increase the risk of several other cancers.
Women aged 25 to 65 who are at average risk for cervical cancer can order the home test directly from the company’s website. The kit is expected to first be available in California starting in June, with plans to expand nationwide as soon as possible.
Teal Health is partnering with key insurance providers to offer flexible payment options, aiming to alleviate financial concerns and enhance access for more women when it comes to this home screening.
Along with the collection kit, users will also have access to telehealth services with support from healthcare professionals throughout the process. Women who test positive for HPV will then be guided toward traditional PAP smears, while those without a positive result won’t need further screening for three to five years.
“Some women may find traditional PAP smears uncomfortable or intimidating, leading them to delay this crucial test,” noted an expert who was not part of the trial. “This tool could significantly increase regular screenings, especially for women lacking healthcare access. Tests that help detect cervical cancer are definitely beneficial.”
