Novoviah Pharmaceuticals has achieved a significant breakthrough in celiac disease diagnostics with their NovoleukinTM test platform, demonstrating 90% sensitivity and 95% specificity in detecting the autoimmune condition through novel T cell reactivity measurements. The results, published in Gastroenterology, represent a collaboration with researchers from the Walter and Eliza Hall Institute of Medical Research (WEHI) analyzing blood samples from 181 volunteers.
Revolutionary Diagnostic Sensitivity
The NovoleukinTM platform measures T cell reactivity in fresh whole blood after 24-hour in vitro stimulation with target antigens. The proprietary technology boosts T cell activity following blood collection, enabling accurate cytokine biomarker measurement compared with unstimulated controls. This approach can detect as few as one gluten-specific T lymphocyte in one milliliter of blood or one per million CD4+ T cells.
"This level of sensitivity in a straightforward blood test is a landmark technical achievement and promises to impact patient care in many fields and accelerate immunotherapy and vaccine development," according to the study findings.
Addressing Current Diagnostic Limitations
The platform's most significant clinical advantage lies in its ability to detect celiac disease in patients following strict gluten-free diets, which typically confounds traditional diagnostic methods. Associate Professor Jason Tye-Din, Head of WEHI's Celiac Research Laboratory and gastroenterologist at Royal Melbourne Hospital, emphasized this breakthrough's clinical impact.
"By stimulating T cells after a blood draw, patients can avoid the need to return to gluten and the suffering that often comes with that – for the sole purpose of diagnosis. That is a major step towards improving outcomes for patients," Tye-Din stated.
Clinical Trial Applications and Therapeutic Monitoring
Originally developed for multi-center clinical trials, the NovoleukinTM system demonstrated predictive capabilities for patient responses during gluten challenge protocols. This functionality underscores its utility in stratifying patients for clinical research and tailoring therapeutic strategies.
Dr. Robert Anderson, co-founder of Novoviah Pharmaceuticals and current President of the International Society for the Study of Celiac Disease, highlighted the platform's practical design for clinical settings. "The test is designed for ease of use in the clinical setting. It can be prepared without specialist equipment and then sent for highly sensitive laboratory analysis. The protocol is simple and reproducible enabling easy rollout across multiple sites."
Broader Therapeutic Development Impact
The platform is already being utilized by leading biopharmaceutical partners to evaluate immune responses during celiac disease clinical trials, providing real-time insights into treatment efficacy. Anderson noted that "non-invasively monitoring T cell reactivity opens the door to transformative clinical applications, particularly in drug development."
Expanding Disease Applications
Novoviah is actively expanding the diagnostic applications of the Novoleukin platform across additional immune-mediated diseases, including viral infections, autoimmune conditions, and certain cancers. The company aims to bring T cell-guided insights to both clinical and research settings, leveraging the platform's ability to monitor disease reactivity status and assess therapeutic effectiveness.
The Brisbane-based biotechnology company, established in 2020, developed the platform specifically to support drug developers, researchers, clinicians, and patients requiring improved treatments and diagnostic capabilities for antigen-specific T cell responses.
