Novoleukin-C Blood Test

Measuring celiac disease gluten-specific CD4+ T cells from a simple blood test

The Novoleukin-C test is a tool to measure the reactivity of celiac disease-specific T cells in patients, without them needing to consume gluten. 

The test exposes fresh whole blood to gluten antigens and measures interleukin-2 released by activated T cells. It builds on detailed understanding of the gluten peptides recognized by CD4+ T cells in celiac disease, and a series of advances that have improved test sensitivity.

Novoleukin-C measures the activity of T cells that cause celiac disease at the time of testing, making it suitable for use in clinical care and for immune monitoring during drug trials.

Patient stratification

Disease severity

Response prediction

Immune monitoring

T cell reactivity during treatment course

Persistence of effect

Disease detection

Disease confirmation

Companion diagnostic potential

Proven performance in celiac disease

Novoviah, working with its clinical collaborators, has extensive experience of the Novoleukin Test System in celiac disease.

Novoleukin-C has been optimized for detecting extremely rare gluten-specific CD4+ T cells in celiac disease (CeD) patients, with frequencies as low as 1 per million CD4+ T cells, or one per 1mL of blood.

These promising findings of the whole blood interleukin-2 (IL-2) release assay (WBAIL-2) support the future use of Novoleukin-C to enable diagnosis of T cell mediated diseases when conventional tests are insufficient.

Clinically proven and globally trusted

The Novoleukin-C test is widely used to monitor gluten-specific T cells across multiple international trials.

Spanning over 100 sites across multiple contients, Novoleukin-C is enabling trials of investigational immune therapies for celiac disease in North America, Europe and Australasia.

The test can be easily processed at clinical sites and the ultrasensitive measurement provided by standardized and matrix-validated cytokine analysis at Novoviah’s specialized laboratory from plasma collected at sites around the world.