FDA Approves At-Home Cervical Cancer Test

Published 22 hours ago• 7 minute read

“[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.

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.

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At-Home Cervical Cancer Screening: An Interview with Dr. Evelyn Reed on The Teal Wand™

Archyde News recently sat down with Dr. Evelyn Reed, a leading gynecological oncologist and researcher at the National Institute of Health, to discuss the FDA-approved Teal Wand™, an innovative new at-home cervical cancer screening device. Dr. Reed provided her insights on the device’s potential to broaden access to screening and improve women’s healthcare.

Archyde News: Dr. Reed, thank you for joining us. The FDA approval of the Teal Wand™ represents a meaningful advancement. Can you provide a brief overview for our readers?

Dr.Reed: Certainly. The teal Wand™ is an at-home self-collection device for HPV testing, designed for women aged 25 to 65. It offers a more accessible and potentially more pleasant alternative to conventional in-clinic Pap tests, and the clinical trial data shows it has a high degree of accuracy.

Archyde News: The study data from the SELF-CERV study highlights impressive accuracy rates. How significant is this, particularly considering the home-based setting?

Dr. Reed: It’s very significant. The study showed the Teal Wand™ correctly identified HPV-positive disease 95% of the time, and correctly identified negative cases 90% of the time. This level of accuracy is crucial, as it assures that women can trust the results and make informed decisions about their health. The 96% sensitivity for detecting HPV when precancer is present, matching the clinician-collected results, is particularly noteworthy. this high level of agreement is critical for identifying precancerous conditions early.

Archyde News: The studies reveal that a significant number of women delay or avoid cervical cancer screenings. How can the teal Wand™ help address this issue?

Dr. Reed: The convenience factor and decreased discomfort are game-changers. Many women cite lack of time, discomfort with the exam, and financial issues as barriers to regular screening. The Teal Wand™ can remove some of these barriers by offering a more convenient and potentially cost-effective alternative. The virtual consultations with medical providers, which the device offers, also help bridge the gap.

Archyde News: The patient profiles in the SELF-CERV study included a diverse range of ages, ethnicities, income levels, and education levels. How crucial is this inclusivity in evaluating the device’s effectiveness?

Dr. Reed: Absolutely crucial.Cervical cancer disproportionately affects certain populations, including those with lower socio-economic resources. Having a broad demographic in the testing is very significant. The study’s inclusion of diverse patients suggests that the Teal Wand™ has the potential to serve as a practical screening method for a wide range of women, providing a more convenient and discreet option for women who may have been previously put off from in-office screenings for financial, convenience, or various other reasons or concerns.

Archyde News: Looking ahead, what do you see as the future impact of at-home screening devices like the teal Wand™ on cervical cancer prevention?

Dr.Reed: I believe we’re on the cusp of a conversion in cervical cancer screening. By expanding access and improving patient experience, these devices have the potential to substantially increase screening rates.This could lead to earlier detection of HPV and precancerous lesions,better patient outcomes,and ultimately,a reduction in cervical cancer incidence and mortality.It is crucial that women adhere to the guidelines of their doctors regarding testing and follow-up procedures.

Archyde News: What potential challenges might arise with the widespread adoption of at-home screening?

Dr.Reed: One challenge is ensuring that women understand the importance of follow-up care if their test results are abnormal. We need to ensure women are educated on the importance of this screening and the follow up. Another is bridging the digital divide, as access to the virtual providers is essential for receiving and understanding results. It’s critically important for the woman to understand the testing and follow-up procedures.

Archyde News: Thank you, Dr. Reed, for sharing your expertise with us. Our readers will certainly find this information helpful. before we conclude, what would you say is the most critically important message about the Teal Wand™ and at-home screening devices?

Dr. Reed: These devices will empower women to actively participate in their health within a familiar habitat. By prioritizing accessibility and convenience, there should be broader screening rates and the potential to reduce the burden of cervical cancer. It could also reduce the rate of delayed or avoided screening across income and insurance types, which is critically important to helping reduce disparities.

Archyde News: Thank you, Dr. Reed.

Dr. Reed: It was my pleasure.

archyde News: What are your thoughts on at-home cervical cancer screening? is the Teal Wand™ a step in the right direction? Share your opinions in the comments below.

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