# Urine glycated CD59 as novel diabetes biomarker amenable to measure with a point-of-care device

> **NIH NIH R44** · MELLITUS, LLC · 2020 · $1,000,000

## Abstract

Project Abstract
Diabetes and pre-diabetes are a high public health priority worldwide because they represent a major cause
of morbidity and mortality in the adult population, and both are growing at an epidemic rate around the globe.
Diabetes and pre-diabetes currently affect close to 9% of the world population and it is estimated that the
global prevalence will increase almost 50% over the next 20 years. Mellitus, LLC is developing a novel test
for screening, diagnosis and monitoring individuals with diabetes, pre-diabetes and gestational diabetes
(GDM). The test is based on the novel biomarker glycated CD59 (GCD59), which was licensed exclusively
by Mellitus from Harvard University. Important features of the biomarker are that it 1) is pathogenically
relevant because of its mechanistic link to the development of diabetic complications, 2) is present not only
in blood but also in urine and other bodily fluids, and 3) has a turn-over rate of ~2 weeks, which is much faster
than HbA1c. Mellitus has already developed an ELISA (Enzyme Linked Immunosorbent Assay) test for blood
levels of GCD59 and is now in the process of developing a new test to measure urine levels of GCD59 in a
point-of-care (POC) format. A POC urine test for GCD59 has the potential to revolutionize the field of diabetes
because it will provide physician and patients a simple, accurate, pathogenically relevant and easy to use
diagnostic test to 1) efficiently screen and diagnose diabetes, pre-diabetes and GDM, 2) monitor treatment
effectiveness and 3) assess the risk of developing the devastating and life-threatening complications of these
conditions. This SBIR Direct to Phase II proposal details the plan to develop a robust POC test for urine
GCD59. The project builds on extensive proof-of-concept data generated with the academic prototype
plasma assay developed at Harvard University and the first-generation manual GCD59 test developed by
Mellitus, which together demonstrate feasibility for the product concept. Two proprietary antibodies have
been developed to provide a quantitative estimate of the urine GCD59/total CD59 ratio. These valuable
reagents have been used in preliminary studies to assess the feasibility and potential clinical utility of the
urine GCD59 test that Mellitus proposes to develop in this application. Mellitus has brought together a top-
tier team with expertise in GCD59, glycation biology and point-of-care assay development to develop a novel,
easy-to-use, accurate and reliable POC test to measure GCD59 levels in urine. This program has attracted
the interest of practitioners as well as national and international potential strategic partners. Award of an
SBIR Phase II grant would accelerate development of a urine GCD59 test that could potentially become the
new standard for screening, diagnosing and monitoring diabetes for the benefit of populations worldwide.

## Key facts

- **NIH application ID:** 10144160
- **Project number:** 1R44DK127725-01
- **Recipient organization:** MELLITUS, LLC
- **Principal Investigator:** Richard Saul
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,000,000
- **Award type:** 1
- **Project period:** 2020-09-16 → 2022-09-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10144160

## Citation

> US National Institutes of Health, RePORTER application 10144160, Urine glycated CD59 as novel diabetes biomarker amenable to measure with a point-of-care device (1R44DK127725-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10144160. Licensed CC0.

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