FDA Approves At-Home Cervical Cancer Screening Kit

"[The Teal Wand] offers an evidence-based way to expand access [to screening] without compromising accuracy,” according to Christine Conageski, MD, MSc, from the University of Colorado Anschutz Medical Campus.

The Teal Wand™, an at-home vaginal sample self-collection device for cervical cancer screening, has been approved by the FDA, according to a press release from the developer, Teal Health.1

The at-home screening kit is intended for patients aged 25 to 65. Additionally, patients will have virtual access to medical providers who will prescribe the kit and review the results.

The approval was based on data from the SELF-CERV study (NCT06120205), which assessed more than 600 patients across 16 study sites in the US.2 The primary end point was positive percent agreement, in which the study identified HPV-positive disease correctly 95% of the time. Additionally, 90% of the time, the test correctly demonstrated negative percent agreement.

“As a principal investigator in the SELF-CERV trial, I saw firsthand how receptive and excited women were to use the Teal Wand. Cervical cancer is largely preventable, yet screening rates in the US 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.” Christine Conageski, MD, MSc, associate professor, OB-GYN, director of the Lower Genital Tract Disease Program, and Residency Program Director at the University of Colorado Anschutz Medical Campus, stated in the press release.1 “[A]ccess is only part of the solution. Comprehensive screening must go hand in hand with structured, reliable follow-up. That’s why Teal Health’s approach to not only advancing screening technology but also providing education and support to women through every step of their care and follow-up journey is crucial. That’s how we ensure this breakthrough truly closes the gap.”

Study demographics showed that 59% of patients were White, 26% were Black or African American, 4% were Asian, and 4% were multi-racial. When ethnicity was assessed, 19% identified as Hispanic or Latinx. Additionally, 25% of patients were between 25 to 29 years old, 44% were 30 to 39 years old, 19% were 40 to 49 years old, and 13% were 50 to 65 years old.

Regarding household income, 18% of patients made less than $19,999, 23% made between $20,000 and $49,999, 29% made between $50,000 and $99,999, 11% made between $100,000 and $149,999, and 11% made more than $150,000. For reference, the median household income in the US was $80,610 in 2023.

Overall, 30% of patients had a high school or GED degree or less education, 24% had some college education or an associate's degree, 32% had a bachelor’s degree, and 15% had a master’s or professional degree. Patients often resided in either a small city or town (24%), the suburbs (32%), or urban areas (44%).

The Teal Wand test was found to have a 96% sensitivity rate, which investigators noted was the same as clinician collection for detecting HPV when precancer is present.

The study found that 33% of patients had delayed or avoided screening. Reasons for delay included lack of time (32%), being uncomfortable with the exam (32%), financial issues (32%), being afraid of the results (16%), or clinic issues where they couldn’t get a visit (15%).

Based on where patients lived, avoidance or delays of screening occurred among those in the suburbs (31%), urban areas (36%), or rural/small cities or towns (28%).

Patients also had delays or avoidance of care across insurance types. This included those who were uninsured (43%), had Medicaid (30%), had Marketplace insurance (43%), had employer-sponsored insurance (30%), or had Medicare (37%).

Patients were included in the trial if they were between 25 and 65 years old and had an intact cervix.3 Eligible patients also had at least 1 of the following features: prior diagnosis of high-risk HPV within the last 6 months; positive Pap cytology within the previous 6 months; or presenting for a colposcopy, LEEP, or excisional intervention.

Patients were excluded if they had undergone partial or complete hysterectomy, including the removal of the cervix; any form of cervical tissue alteration or surgery within 5 months or less; menstrual bleeding; or participation in another clinical trial that may have interfered with the study results.

References

1. FDA approves Teal Health’s Teal Wand™—the first and only at-home self-collection device for cervical cancer screening, introducing a comfortable alternative to in-person screening. News release. Teal Health. May 9, 2025. Accessed May 15, 2025. https://tinyurl.com/y3cd5a3y
2. At-home cervical cancer screening is as accurate as in-clinic, and preferred by 94% of women. Teal Health. May 2025. Accessed May 15, 2025. https://tinyurl.com/y48srnnz
3. SELF-CERV pivotal study: SELF-Collection for CERVical Cancer Screening. ClinicalTrials.gov. Updated March 26, 2025. Accessed May 15, 2025. https://tinyurl.com/5n88u82k