The U.S. Food and Drug Administration (FDA) has approved the first and only at-home self-collection device for cervical cancer screening, offering an alternative to the traditional Pap smear that has been the standard for more than 80 years.
The newly approved device, known as the Teal Wand, allows women to collect their vaginal sample at home and mail it to a certified laboratory for analysis, eliminating the need for an in-office gynecological exam.
Developed by San Francisco-based Teal Health, the Teal Wand is a prescription-only device designed for individuals aged 25 to 65 who are at average risk for cervical cancer. The process is straightforward:
- Patients order the test online and consult with a healthcare provider via telehealth.
- Using a sponge-like swab, they collect a vaginal sample themselves-no speculum or in-office visit required.
- The sample is mailed to a laboratory, where it is tested for human papillomavirus (HPV), the virus responsible for nearly all cases of cervical cancer.
If a patient tests positive for HPV, they are referred for a traditional Pap smear for further evaluation.
Clinical trials involving over 600 women showed that samples collected at home with the Teal Wand were as accurate as those collected by healthcare professionals in a clinical setting, with a reported 96% accuracy rate.
Cervical cancer is highly preventable with regular screening, yet many women delay or avoid Pap smears due to the invasiveness of the traditional procedure. By enabling self-collection in the privacy of one’s home, the Teal Wand aims to increase participation in life-saving cervical cancer screening programs, especially among underserved populations and those in remote areas.
The Centers for Disease Control and Prevention estimates that about 11,500 new cases of cervical cancer are diagnosed annually, with around 4,000 deaths.
The device will be available by prescription through Teal Health’s telehealth platform, with an initial rollout in California starting in June and plans for national expansion. The company is also working with insurers to secure coverage and seeking ways to make the test affordable for uninsured individuals.
