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

> **NIH NIH R44** · TEAL HEALTH INC · 2024 · $1,114,893

## Abstract

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.

## Key facts

- **NIH application ID:** 11008315
- **Project number:** 1R44CA291336-01A1
- **Recipient organization:** TEAL HEALTH INC
- **Principal Investigator:** Trena Depel
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,114,893
- **Award type:** 1
- **Project period:** 2024-09-23 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008315

## Citation

> US National Institutes of Health, RePORTER application 11008315, Evaluation of the Teal self-collect device for cervical cancer screening (1R44CA291336-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11008315. Licensed CC0.

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