# Advancing an accessible, high-throughput and multiplex islet autoantibody test with self-collected capillary dried blood spots for regulatory clearance

> **NIH NIH R44** · ENABLE BIOSCIENCES, INC. · 2024 · $968,473

## Abstract

Project Summary
Type 1 diabetes, a chronic autoimmune disorder that affects millions of Americans is characterized by
the progressive destruction of the insulin-producing islet cells of the pancreas, resulting in life-long
dependency on insulin therapy. Many people with type 1 diabetes are diagnosed with life-threatening
diabetic ketoacidosis and develop a panoply of perilous complications affecting every organ over their
shortened life spans. Testing for the presence of anti-islet autoantibody biomarkers in blood accurately
predicts whether individuals are at risk for developing type 1 diabetes. Autoantibody screening programs
have been shown to support interventions that reduce the rates of diabetic ketoacidosis and they help
identify eligible candidates for new interventions that may delay or prevent the onset of type 1 diabetes.
However, no current testing method exists that combines accuracy, speed, scalability, and the ability to
collect samples at home.
In application is a follow-on to Enable Biosciences Phase 2 NIDDK SBIR Award R44DK111005
Phase 2B application we are seeking NIDDK support for the process of FDA clearance and
comprehensive quality system implementation of our unique dried blood spot test for T1D autoantibodies
based on our innovative patented Antibody Detection by Agglutination-PCR (ADAP) technology. ADAP
is highly sensitive and ultra-specific and has been repeatedly validated as a top-performing T1D
autoantibody assay in blinded peer-reviewed published clinical studies.
In Specific Aim 1, we will develop a comprehensive quality system to allow for reliable and high-quality
manufacturing of test components to be used for the FDA study. Reagents, materials, protocols, and
document control systems will be developed and documented in compliance with FDA requirements.
In Specific Aim 2, we will perform standard laboratory analytical validation of the assay, determining the
reproducibility, limit of blank, limit of detection and limit of quantification, as well as performing
interference analysis by spiking in common adulterants into test samples.
In Specific Aim 3, we will perform our clinical validation in collaboration with nationwide and, if needed,
global clinical specimen collection sites to establish non-inferiority with the predicate device.
. For this

## Key facts

- **NIH application ID:** 10845614
- **Project number:** 5R44DK111005-05
- **Recipient organization:** ENABLE BIOSCIENCES, INC.
- **Principal Investigator:** David Seftel
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $968,473
- **Award type:** 5
- **Project period:** 2016-08-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10845614

## Citation

> US National Institutes of Health, RePORTER application 10845614, Advancing an accessible, high-throughput and multiplex islet autoantibody test with self-collected capillary dried blood spots for regulatory clearance (5R44DK111005-05). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10845614. Licensed CC0.

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