# A Point of Care Test to Monitor and Promote Adherence to Tenofovir-based regimens for the Prevention and Treatment of HIV

> **NIH NIH R44** · URSURE, INC. · 2020 · $933,742

## Abstract

PROJECT ABSTRACT
 This CRP SBIR project aims to launch to market a point-of-care (POC) test to measure patient
adherence to Pre-exposure Prophylaxis (PrEP) as a prevention against HIV infection in people known
to be at risk of HIV exposure, and to antiretroviral therapy (ART) as treatment to HIV. HIV contributes to
millions of infections and deaths per year and tens of billions of dollars in healthcare costs around the world.
PrEP is 99% effective at preventing HIV infection if taken daily, but adherence in poor. PrEP is recommended
by the CDC in populations at a high risk of HIV infection, which include men who have sex with men,
intravenous drug users, and serodiscordant couples. Similarly, ART, can be effective and suppress viral load
when following the dosing schedule. Due to poor adherence, not only are patients inappropriately treated, the
chance of developing resistant strains is increased. Drug adherence monitoring is well known to improve drug
compliance, but currently there are no commercial products for rapid adherence monitoring of PrEP and
ART. To be acceptable to patients and feasible in the physician workflow, this adherence test needs to be
non-invasive, painless, inexpensive, easy to administer and provide rapid, accurate results. The UrSure
Rapid Tenofovir POC test measures tenofovir (TFV), which is a component of PrEP and 90% of ART
regimens. This project has successful completed Phase I where we demonstrated the feasibility of this
approach. A novel TFV derivative was synthesized and used to produce novel anti-TFV antibodies that are
specific and sensitive for TFV. In Phase II Year 1, we successfully developed a prototype with 100% sensitivity
and 100% specificity and are currently in Phase II Year 2 verifying the LFIA performance to initiate technology
transfer to our contract manufacturer. The POC test is noninvasive, painless, rapid (minutes to get a result)
and inexpensive. It can be used during a clinic visit to measure PrEP adherence and, if appropriate, counsel
patients on how to improve compliance.
 To be able to prepare the UrSure Tenofovir Rapid Test for commercialization, we are looking to engage
in a CRP project. The objective of this CRP project is to conduct all validation studies required for the
regulatory processes to allow our device to gain market approval globally. The Aims are to: 1) Evaluate
intra and inter-lot validation and reproducibility of the scaled-up assay, 2) Conduct analytical validation studies
for a FDA 510k submission, and 3) Conduct and submit flex studies to obtain CLIA-waiver. UrSure has
relationships in place with experts and organizations with deep experience in regulatory process, especially in
the diagnostics and medical devices. The final deliverables of this CRP project will be validated and scale-up
manufacturing process, and submissions to obtain FDA pre-market approval, CLIA-waiver, and CE Mark
approval. Successful completion of this CRP project will result in a validated prototyp...

## Key facts

- **NIH application ID:** 10011595
- **Project number:** 3R44MH114864-03S1
- **Recipient organization:** URSURE, INC.
- **Principal Investigator:** Giffin Daughtridge
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $933,742
- **Award type:** 3
- **Project period:** 2017-06-09 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10011595

## Citation

> US National Institutes of Health, RePORTER application 10011595, A Point of Care Test to Monitor and Promote Adherence to Tenofovir-based regimens for the Prevention and Treatment of HIV (3R44MH114864-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10011595. Licensed CC0.

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