Clinical applications in celiac disease

The Novoleukin-C blood test promises to be the first test capable of diagnosing celiac disease with high sensitivity and specificity, without requiring intestinal biopsies - even in individuals who have avoided dietary gluten.

T cell testing in celiac disease

Celiac disease is estimated to affect 1 in 100 people worldwide, but only about 30% are properly diagnosed.

It is caused by an abnormal intestinal T cell response to gluten proteins of wheat, barley and rye. Standard medical tests such as serology (antibody tests) or biopsies (histology) often indirectly measure the disease-causing or protective effects of T cells.

More reliable tests are required both for clinical diagnosis and for disease monitoring.

The Novoleukin-C blood test 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.

The test mimics how gluten activates a celiac disease patient’s immune system. It presents small gluten fragments (antigens) to the immune system cells in a blood draw tube. Through an immune pathway, the antigens activate disease-specific T cells, which causes them to release cytokines. Finally, we measure the degree of cytokine release as an indication of the severity of an immune response, and the sensitivity of a patient’s response to the gluten antigen.

The Novoleukin-C test is widely used to monitor gluten-specific T cells in multicenter clinical trials of investigational immune therapies for celiac disease in North America, Europe and Australasia, and can be easily processed at clinical sites.

Learn more about how Novoviah can support celiac and autoimmune disease drug development.

Blood based T cell testing for celiac disease

The Novoleukin-C test utilizes fresh whole blood incubated with gluten antigens to assess interleukin-2 released by activated T cells.

Unlike current clinical diagnostic tests that measure the effects of gluten in celiac disease, the Novoleukin-C blood test aims to measure the specific T cells that cause celiac disease.

The Novoleukin-C test for gluten-specific T cells associated with celiac disease is reliable even in patients who have not completed a gluten food challenge.

Standardized gluten for clinical food challenges to inform study endpoints

Novogluten provides greater confidence to patients, clinicians and researchers that the effects they observe following gluten food challenge in patients with celiac disease are due to a calibrated activation of gluten-specific immunity rather than irritable bowel syndrome or other non-immune effects.



Our specialists at Novoviah have over 25-years experience in designing, managing and interpreting gluten food challenges in clinical care, immunology research and in pharmaceutical development.

Drug mechanism proof of concept

Demonstrate your drug concept in celiac disease in vivo or ex vivo

Leverage Novoviah’s deep knowledge of the adaptive immune system and clinical presentations of celiac disease to run an accelerated proof of concept study to demonstrate the activity of novel immune-targeting therapeutics.

The proof of concept study can help you measure:

• Whether your therapeutic stimulates or antagonises CD4+ T cells directly
• Bystander effects of your therapeutic to various immune targets
• If drug pre-treatment changes patient responsiveness to stimulatory antigens, ex vivo or in vivo
• The efficacy a multi-indication therapeutic in celiac disease before expanding to other conditions

Novoviah can enable a rapid study by designing the clinical and testing protocol, performing patient recruitment, using the Novoleukin test system as an immune monitoring tool, and analysing and interpreting results.

Talk to us to understand how we can help you generate proof of concept, mechanism, and efficacy data quickly.