FDA approves Teal Wand HPV test

The U.S. Food and Drug Administration on May 9, 2025 approved Teal Health’s Teal Wand, a prescription device that lets patients collect a vaginal sample at home for cervical-cancer screening. The clearance makes Teal Wand the first FDA-authorized at-home self-collection device for that purpose in the United States, according to Teal and an FDA decision summary. The device is intended to collect and transport vaginal specimens for use with an FDA-approved HPV molecular assay that has been validated with the collection method. Teal said patients will mail the sample to a certified lab and receive support through the company’s telehealth service. ### What exactly did the FDA authorize? The FDA’s de novo decision summary says Teal Wand is a Class II device under 21 CFR 866.2920 for home collection and transportation of clinical specimens by lay users for infectious-disease testing. The indication allows self-collection of vaginal specimens for use in an FDA-approved HPV molecular assay with which the device has been validated, and the authorization says it can be used at home or in another private setting. The FDA summary also states the product is prescription-only. (accessdata.fda.gov) The FDA document says the device has been validated only with Roche’s cobas HPV test run on the cobas 5800, 6800 and 8800 systems. Teal said the sample is tested on the same HPV assay used in clinics, and described the product as an alternative collection method rather than a new lab test. ### How does the device work at home? The FDA decision summary describes Teal Wand as a single-use plastic device with a swab-like projection and foam sponge for self-collection of a vaginal specimen. (accessdata.fda.gov) The kit also includes an empty specimen vial, gloves, instructions, a safety bag and a return mailer, according to the agency’s summary. Specimens are collected, stored and shipped dry to a laboratory for downstream high-risk HPV testing. The FDA summary says the user inserts the device, deploys the collection end with a dial, rotates it 10 times, and retracts it before removal. Teal said the product does not require a speculum and will be offered with virtual access to company medical providers who prescribe the kit, review lab results and support patients through the process. ### How is this different from earlier HPV self-collection approvals? (accessdata.fda.gov) On May 14, 2024, the FDA expanded approvals for BD’s Onclarity HPV test and Roche’s cobas HPV test to allow patients to collect vaginal samples themselves in a healthcare setting, the National Cancer Institute said. NCI said those earlier approvals still required collection in places such as doctors’ offices, urgent-care centers, pharmacies or mobile clinics. (accessdata.fda.gov) NCI’s Vikrant Sahasrabuddhe said in 2024 that those healthcare-setting approvals were a “first step” toward broader approvals, including home collection. The agency also said its SHIP trial network was launched to study whether home self-collection works as well as clinician collection. ### What evidence did Teal cite for the approval? A JAMA Network Open study published May 19, 2025 reported results from a nonrandomized trial of 599 people with paired self-collected and clinician-collected samples. (cancer.gov) The study said self-collected samples showed high positive agreement for high-risk HPV detection and equivalent sensitivity for cervical dysplasia, while also confirming safety and usability. The study enrolled participants ages 25 to 65 at 16 U.S. clinical sites between November 2023 and April 2024. Teal said the prescription device will be available for average-risk individuals ages 25 to 65 through its website. ### Where does this fit in cervical-cancer screening guidance? The National Cancer Institute said in March 2025 that new consensus guidance found self-collected vaginal specimens acceptable for primary HPV screening in asymptomatic, average-risk individuals. (pmc.ncbi.nlm.nih.gov) NCI also said laboratory and clinical workflows would need changes to support specimen processing and follow-up. ACOG said on April 23, 2026 that its updated cervical-cancer screening guidance, for the first time, includes patient-collected high-risk HPV testing as an option. (pmc.ncbi.nlm.nih.gov) ACOG said primary high-risk HPV testing every five years is preferred for average-risk patients ages 30 to 65, and that patient-collected sampling every three years is an option when patients prefer it and clinical follow-up systems are in place. (dceg.cancer.gov) Teal said the next step is a commercial rollout through getteal.com, where its telehealth service will prescribe the kit and return results for average-risk patients ages 25 to 65. ACOG’s April 2026 guidance and NCI-backed management recommendations now provide the clinical framework that providers will use as patient-collected HPV screening expands. (getteal.com) (acog.org)