The FDA approved
the first at-home test for cervical cancer screening in people at average risk ages 25 to 65, maker Teal Health announced on Friday.
The test is comprised of a wand with a sponge-like tip for collecting cells (Teal Wand) and does not require a speculum. Patients then ship their sample to a certified lab for processing.
FDA last year approved the first self-collection kit for detecting human papillomavirus (HPV) -- the virus that causes nearly all cervical cancers -- but only for use in healthcare settings. The new at-home device uses the same Roche testing system, cobas HPV, which is used for primary screening and co-testing and can detect cervical intraepithelial neoplasia of grade 2/3 or worse.
The SELF-CERV study supported the new approval and included more than 600 participants who self-collected a sample using the device. Then a clinician collected a sample via a speculum exam to compare sample results. Participants also completed feedback surveys on usability.
Overall, 98% of the women in the study successfully collected a valid sample and 93% said the device was easy to use. Nearly all (94%) said they would prefer self-collecting at home over in-person screening with a clinician if they knew the results would be just as accurate as their doctor, and 86% said they would be more likely to stay up to date with routine screening with an at-home test.
"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," said investigator Christine Conageski, MD, of the Complex Dysplasia Clinic at the University of Colorado, in a statement.
Teal Health also provides telehealth services for prescribing the screening kit, reviewing the test results with patients, and for follow-up needs.
"Access is only part of the solution. Comprehensive screening must go hand in hand with structured, reliable follow-up," Conageski said. "That's how we ensure this breakthrough truly closes the gap."
The U.S. Preventive Services Task Force recently announced plans to add self-collected HPV testing to its recommendations for cervical cancer screening. Experts have said that the trend toward self-collection and at-home collection can help patients feel more comfortable with HPV testing, potentially reducing barriers to receiving critical preventative care.
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