Start-up launches clinical trial studying device for cervical cancer

The US women’s health start-up Teal Health has announced a clinical trial for its self-collection device for cervical cancer.

Part of Teal Health’s platform for tackling cervical cancer, the Teal Wand aims to make it easier for women to collect cervical cancer screening samples from home.

According to the developers, the device is designed to increase women’s confidence and adherence to screen for primary HPV and Pap cytology triage and enable conversation and engagement with medical professionals.

The clinical trial, in progress at Johns Hopkins, Yale University, University of Colorado, University of Wisconsin and Washington University, is hoped to support FDA submission and approval of the wand.

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

Discomfort during the exam, lack of information, time and access to gynaecological care are all barriers that have contributed to women not maintaining cervical cancer screenings.

The Teal Wand could potentially help women collect their own vaginal sample from home, without the need for an invasive exam.

“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, co-founder and CEO of Teal Health.

“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, prioritising and respecting a woman’s needs, time, and preferred experience.”

Teal Health’s nationwide clinical 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 per cent of cervical cancers.

HPV testing is recommended as the preferred cervical cancer screening method by multiple medical guidelines, including the American Cancer Society.

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

“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.”

Elizabeth Sutton, principal investigator from the Woman’s Hospital in Baton Rouge, Louisiana, added: “Women in our community experience many barriers when it comes to accessing care.

“What we’ve loved about working with Teal is the excitement by the participants to be a part of the study, and to have their input and experience matter.”