Celiac Disease

There are two published reports of an earlier 96-well “academic” lab version of the test, which captured the attention of leading pharmaceutical companies. 

Since then, Novoviah has improved the test and transitioned to a more convenient “in-tube” version which can be used in remote sites in a clinical trial or could be used in the clinic for diagnostic purposes. 

Novoviah working with its clinical collaborators has extensive experience of the Novoleukin Test System in 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. This is a landmark achievement in the field and singles out the Novoleukin Test System as the only format apart from tetramer-based flow cytometry tests with the sensitivity to detect gluten-specific CD4+ T cells at frequencies as low as one per million in blood. These promising findings suggest the Novoleukin Test System could in future be developed to support clinical diagnosis in T cell-dependent diseases enabling diagnosis when conventional tests are insufficient such as for celiac disease in patients already strictly avoiding gluten. 

Clinical application of reliable tests for antigen-specific T cells promises improved, more convenient diagnosis and expediting personalised therapy through better monitoring of T cells causing or eradicating disease e.g. autoimmune and allergic disease, and cancer immunotherapy. 

Novoviah’s ultrasensitive Novoleukin Test System is as versatile and as the antigen selected to stimulate blood. The Novoleukin Test System has excited researchers and drug developers because of its success in celiac disease positioning it as the first simple clinical test with the necessary sensitivity to reliably detect antigen-specific T cells responsible for common diseases. 

Research scientists using specialised techniques in immunology labs have been studying antigen-specific T cells for many years because they are the master-control for acquired immune responses protecting against infections and cancer, induced by vaccines, or causing autoimmune and allergic diseases. 

Standard medical tests such as serology (antibody tests) or biopsies (histology) often indirectly measure the disease-causing or protective effects of T cells, but current T-cell tests have proven impractical in the clinic except for the important exception of diagnosing tuberculosis.