Home-collected dried blood spot test for type 1 diabetes antibodies
Advancing an accessible, high-throughput and multiplex islet autoantibody test with self-collected capillary dried blood spots for regulatory clearance
['FUNDING_SBIR_2'] · ENABLE BIOSCIENCES, INC. · NIH-11159427
This project is making a fast, accurate home finger‑prick test to detect the antibodies that signal risk for type 1 diabetes.
Quick facts
| Phase | ['FUNDING_SBIR_2'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | ENABLE BIOSCIENCES, INC. (nih funded) |
| Locations | 1 site (South San Francisco, UNITED STATES) |
| Trial ID | NIH-11159427 on ClinicalTrials.gov |
What this research studies
From your perspective, this work is adapting a lab test so you can collect a tiny blood sample at home via a finger prick onto a dried blood spot card and mail it in. The lab uses a sensitive multiplex method called Antibody Detection by Agglutination‑PCR (ADAP) to look for multiple islet autoantibodies from that small sample. The team aims to scale the test for high-throughput processing and gain FDA clearance while building quality systems to run it clinically. If approved, the test could be used in screening programs to find people at risk and link them to preventive options.
Who could benefit from this research
Good fit: Ideal candidates are people at increased risk for type 1 diabetes—such as relatives of people with T1D, children in screening programs, or anyone recommended for autoantibody testing—who can do a home fingerstick and mail a sample.
Not a fit: People already diagnosed with type 1 diabetes or those unable or unwilling to perform a finger‑prick and mail samples would not directly benefit from this risk‑screening test.
Why it matters
Potential benefit: If successful, this could make it much easier to screen people for type 1 diabetes risk from home, helping catch disease earlier and reduce emergency diagnoses like diabetic ketoacidosis.
How similar studies have performed: Laboratory autoantibody assays and dried blood spot collection have been used successfully in other screening programs, and ADAP has shown strong performance in blinded studies, though combining multiplex ADAP with home dried blood spots for T1D screening is a newer, regulatory‑focused step.
Where this research is happening
South San Francisco, UNITED STATES
- ENABLE BIOSCIENCES, INC. — South San Francisco, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: SEFTEL, DAVID — ENABLE BIOSCIENCES, INC.
- Study coordinator: SEFTEL, DAVID
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Autoimmune Diseases