Today, in honor of Cervical Cancer Awareness Month, Teal Health, a women's health company focused on increasing access to cervical cancer screenings in the US, announces the SELF-CERV clinical study, in progress at leading health organizations including Johns Hopkins, Yale University, University of Colorado, University of Wisconsin, Washington University, and many more. Teal Health’s clinical trial is designed to support FDA submission and approval of their novel at-home self-collect device, the Teal Wand^™. By offering an alternative to an in-person doctor’s visit for a speculum exam, Teal Health will be able to provide women and people with a cervix a choice and greater access to this critical health screening, on which 1 in 4 women in the US are not up-to-date. 

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Cervical cancer is nearly 100% preventable when caught early yet, in the United States, more than 12,000 people are being diagnosed and over 4,000 die of the disease each year, disproportionately impacting Black, Asian, and Hispanic women. More than 50% of these diagnoses are later stage and among people who did not have a recent screening. 

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The Teal Wand is a proprietary device designed to enable people to easily, comfortably, and confidently collect their own vaginal sample from the convenience and privacy of their home or health clinic, without the need for an invasive exam. Discomfort during the exam, lack of information, time, and access to gynecological care are all barriers that have contributed to women not maintaining cervical cancer screenings. In the US, there is a shortage of gynecology care where nearly 50% of US counties do not have an OBGYN. The Teal Wand, which is ergonomically designed for a broad range of bodies and health literacy levels, will be able to address these barriers head-on and help increase adherence to screening guidelines for primary HPV.

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Teal Health’s nationwide clinical study has over 15 distinguished health organizations participating in the research including multiple Planned Parenthood Research Network locations, Woman’s Hospital in Baton Rouge, Alabama Clinical Therapeutics/Birmingham OBGYN, and Unified Women’s Clinical Research, with more to be announced. The study is enrolling participants and comparing results from patient self-collection to a clinician collection using a speculum for the detection of high-risk HPV, which are the strains of the HPV virus that cause more than 90% of cervical cancers. HPV testing is recommended as the preferred cervical cancer screening method by multiple medical guidelines, including the American Cancer Society.

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"Through my medical practice as the director of the complex dysplasia clinic, working to increase screening rates is a top concern,” said Dr. Christine Conageski, Associate Professor and OB-GYN at the University of Colorado Anschutz Medical Campus.

“With national screening rates plateauing or even declining in areas, it requires new approaches to make significant progress. At-home screening options will provide a great alternative to the in-person traditional speculum exam and will increase access and address screening barriers, specifically the need for a more convenient and comfortable experience for women."

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This clinical study follows an initial study that included over 220 participants ranging in age, race, socioeconomic status, and education across multiple states and regions. The study demonstrated that not only did participants successfully self-collect a sample, but that it was much preferred to the speculum - 92% said if they knew the results were equal they would prefer self-collection, and 87% reported they would stay current with screening if Teal Wand was an option. Self-collection took the vast majority under 2 minutes to complete, and 97% of study participants reported it was very easy or easy to use. 

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Elizabeth Sutton, PhD, Principal Investigator from the Woman’s Hospital in Baton Rouge, Louisiana says,

"Women in our community experience many barriers when it comes to accessing care. What we've loved about working with Teal in the initial study and now moving into the clinical trial is the excitement by the participants to be a part of the study, and to have their input and experience matter."

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“Self-collection is now a viable option thanks to advancements with primary HPV assays, mirroring practices seen in other parts of the world,” said Kara Egan, CEO and Co-founder of Teal Health. “The self-collection approach enables us to revolutionize the screening process and design it for the modern woman. We’re thrilled to have such incredible partners and participants help us execute on this life-saving screening option in the United States, prioritizing and respecting a woman’s needs, time, and preferred experience.”

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This Cervical Cancer Awareness Month, Teal Health is raising awareness about the importance of life-saving cervical cancer screening with their ‘Close the Screening Gap’ initiative. For individuals who help spread the word, Teal Health will donate up to 1,000 free screenings when a self-collect option becomes FDA approved. Learn more here.

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About Teal Health
Teal Health is on a mission to design a better healthcare experience for women - starting with cervical cancer screenings. By creating the option for a woman to collect her own screening sample from the comfort of her home or health clinic and providing telehealth follow-up, Teal can increase access to this critical screening and work toward eliminating cervical cancer as a public health concern. To learn more, visit www.getteal.com or follow Teal on Twitter at @tealhealth.

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CONTACT INFORMATION
Lisa Santos
‍lisa@tealhealth.co
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