Evaluation of the Teal self-collect device for cervical cancer screening

PROJECT SUMMARY Limited access to and insufficient uptake of screening remain persistent barriers to cervical cancer elimination as a public health threat. The Teal Health self-collect device (Teal Wand) is designed to help women collect their own vaginal sample for Human Papillomavirus (HPV) testing on FDA approved assays for primary HPV. The technical innovation of the Teal device is the textured sponge which collects abundant cellular/viral material and shows promise for storing HPV samples dry and eluted into FDA-approved preservative, thus enabling rapid integration with current FDA-approved workflows on HPV assays. Self-collect HPV, the causative virus of most cervical cancers, allows a woman to collect her own vaginal sample, thereby doubling (or more) participation in screening. Participation among groups with access barriers is critically important for Teal Health, and a primary reason to pursue FDA approval for the Teal self-collect device for at- home screening. No FDA approved at-home self-collect devices are available for cervical cancer screening in the US. Teal Health is seeking FDA approval for the Teal Wand for an at-home self-collection indication to enable Teal telehealth well woman visits, our main source of revenue, thus expanding access to preventive screenings for millions of women who experience barriers or are accessing preventive care. Our clinical study design and analytical testing plans have been informed by feedback resulting from four FDA pre submissions. In this direct to Phase II submission, we propose a clinical study to evaluate the Teal self-collect device compared to a clinician collected sample for submission to FDA for a De Novo classification (Phase II) for primary HPV screening for cervical cancer. As part of this effort, we propose the following Aim: Conduct a clinical study, with the subject serving as their own control, to confirm the usability of the Teal Wand and agreement for detection of HPV of self-collected sample collected using the Teal Wand compared to a clinician collected sample, both collected during the same visit in an outpatient setting and stored dry up to 7 days to mimic at-home collection, storage, and shipping. This will be broken into two tasks: (1.1) Confirm the usability of the Teal Wand for self-collection; and (1.2) Evaluate the percent agreement of the Teal self-collect device for detection of HR-HPV from samples stored dry for 7-10 days as compared to standard of care clinician collected samples. This data will support our De Novo FDA classification request. Self-collect screening at home combined with the Teal Telehealth platform has the potential to access and engage more women in cervical cancer screening than any available method on the market and unlock access to additional preventive care visits.