Teal Health begins clinical trials for its self-collect cervical cancer screening device
The Teal Wand study is in progress in 15 leading health organisations
In the US, 1 in 4 women are not up-to-date with cervical screening. But what if screening could be done without the embarrassment or discomfort of the trip to a doctor’s office - quickly and easily at home?
Now, a revolutionary access-anywhere self-collect cervical cancer screening from Teal Health is tracking towards FDA submission and market availability in the US.
Teal Health’s SELF-CERV Clinical study is in progress with 15 leading health organisations including Johns Hopkins, Yale University, University of Colorado, University of Wisconsin, Washington University, and more.
This clinical trial is testing Teal Health’s proprietary device the ‘Teal Wand.’
FDA-submission will follow, and once approved, San Francisco-based Teal Health aims to market the first such device in the US.
Kara Egan, CEO and Co-founder of Teal Health said:
"Self-collection is now a viable option thanks to advancements with primary HPV assays, mirroring practices seen in other parts of the world."
"The self-collection approach enables us to revolutionise 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."
The need for easier, more comfortable cervical screening
In the US, 25% of women are not up-to-date with cervical screening. That’s a huge issue since cervical cancer is nearly 100% preventable when caught early. Yet sadly in the US, 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.
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.
The wand also helps overcome resourcing issues. In the US, there is a shortage of gynaecology 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.
A global drive to eradicate cervical cancer
While the Teal Wand would be the first FDA-approved self-collect device in the US, countries globally are looking at similar ways to tackle cervical cancer as a public health concern.
Earlier this month, British Columbia announced it would test for cervical cancer through HPV screening and allowing patients to collect a sample themselves at home. From 29 January 2024 free screening kits will be available.
The Australian Government announced in November 2023 that it would aim to eradicate cervical cancer by 2035. A $48.2m investment over four years will improve access to screening and follow-up services.
In the UK, NHS England promised in November 2023 to eliminate cervical cancer by 2040. It will expand self-test screening kits as part of its drive to increase screening - since one in three eligible for screening does not come forward for it.
In India, a three-year vaccination drive will begin later this year to target girls aged 9-14 years old to significantly reduce cervical cancer cases. In India, like many countries, the majority of cases are diagnosed at an advanced stage.
The Teal Wand study
Teal Health's nationwide clinical study has over 15 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.
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.
Prior to this study, Teal conducted a 225+ person study, where they were able to prove that not only were women able to collect an adequate sample with equivalent results to that of the clinician collected sample, but that it was a much preferred experience.
97% of women said it was easy or very easy to use
92% said they would choose self-collect over the current standard of care with a clinician collecting
87% said they would be more likely to get screened if the Teal Wand were an option.
Elizabeth Sutton, PhD, Principal Investigator from the Woman's Hospital in Baton Rouge, Louisiana said:
"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."