Novoleukin-T1D

Measuring islet antigen-specific T cell reactivity from a simple blood test

Novoleukin-T1D enables standarized T cell testing to better measure, monitor and understand the role of autoreactive T cells in the onset and progression of type 1 diabetes.

Type 1 diabetes is an autoimmune condition where autoreactive T cells infiltrate the pancreatic islets and drive the destruction of the body's own insulin-producing beta cells.

While current methods rely on autoantibody screening to identify at-risk individuals and support diagnosis, these markers do not reflect the active T cell response driving the disease, or how that response shifts over time and in response to intervention.

Detecting and measuring islet autoantigen-specific T cells offers the potential to enable early diagnosis, longitudinal disease monitoring and pharmacodynamic assessment of therapeutic response.

Mapping disease progression

Explore whether T cell reactivity tracks how quickly or slowly disease is progressing, to help inform treatment timing decision.

Monitoring disease-modifying therapies

Measure changes in antigen-specific T cell reactivity before and after dosing as a pharmacodynamic biomarker readout for developing T1D therapeutics.

Supporting novel development leads

Extend the same whole-blood assay to other T1D islet autoantigens. Custom assays can be tailored to a specific clinical or drug development program.

Standardized T cell testing for type 1 diabetes research and clinical trials

The Novoleukin Test System pairs ex vivo T cell stimulation from fresh whole blood with ultrasensitive cytokine detection, delivering standardized, optimized conditions for antigen-specific T cell testing.

Built for difficult-to-detect samples
The protocol works directly from a low-volume whole blood draw, with no cell isolation or processing required, addressing the rare-cell frequency and sample volume challenges that have traditionally limited T cell testing.

Beyond detection

This functional measurement from a simple, low volume blood draw makes it easier to monitor disease activity and response to treatments, from immune activation to beta-cell loss across the disease stages.

Built for use across translational research through clinical development.

Extending a proven, ultrasensitive T cell testing platform to Type 1 Diabetes, starting with preproinsulin

The Novoleukin-T1D test is designed to measure preproinsulin-specific T cells directly, applying the same whole-blood, antigen-stimulated cytokine release methodology validated in celiac disease with Novoleukin-C.

Preproinsulin (PPI) is one of the earliest and best characterized T cell autoantigens, with specific regions like C-peptide implicated in type 1 diabetes and at-risk individuals. The Novoleukin-T1D test uses ex vivo incubation of fresh whole blood with antigenic peptide mixtures covering different regions of PPI, one of the major autoantigens in type 1 diabetes. 

The antigenic peptide mixtures in the Novoleukin-T1D test are designed to include epitopes recognized by both CD4⁺ and CD8⁺ T cells to enable measurement of cytokine release reflects PPI-specific T cell reactivity.

Find the right T cell biomarker for your program with Novoleukin T1D

No two type 1 diabetes programs are the same, and Novoleukin-T1D is built to match.

• Use known beta-cell peptide antigens (e.g. GAD65, IA2 and others), or run thorough epitope mapping to identify novel T cell epitopes in your antigen of interest
• Develop custom type 1 diabetes assays tailored to your pre-clinical or clinical program
• Ex vivo testing to de-risk early drug development decisions
• Track T cell activity before and after drug treatment

Established protocols for multi-site trials

We are applying the same assay method, laboratory infrastructure, and multi-site deployment as the Novoleukin-C test to build an ultrasensitive test for rare antigen-specific T cell detection in Type 1 Diabetes. 

Novoleukin tests have been in active use since 2022 across multiple international trials, deployed to over 100 sites across 12 countries with established global logistics.