June 10, 2025

Novel T cell measurement system by Novoviah Pharmaceuticals demonstrates high accuracy for clinical disease detection and monitoring of celiac disease

Novoviah Pharmaceuticals announces that their novel clinical platform technology for detecting and monitoring disease by measuring immune reactivity has been successfully tested in Celiac Disease, with results published inGastroenterology.


The NovoleukinTM test platform, developed specifically for clinical use, measures T Cell reactivity in fresh whole blood after 24-hour in vitro stimulation with a target antigen. The proprietary technology boosts T Cell activity after blood collection, enabling accurate cytokine biomarker measurement and comparison with unstimulated controls. This can be used to monitor disease reactivity status and the effectiveness of prospective therapeutics. 


Originally developed for multi-center clinical trials, the NovoleukinTM system has potential for broader clinical use. Its utility and performance were demonstrated in collaboration with WEHI researchers who analyzed blood samples from 181 volunteers to identify the presence and assess the severity of celiac disease.


The results show high sensitivity (90%) and specificity (95%) in detecting celiac disease, even in patients following a strict gluten free diet which normally confounds traditional diagnostic methods.


The test detects 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.


Associate Professor Jason Tye-Din, Head of WEHI’s Celiac Research Laboratory and a gastroenterologist at the Royal Melbourne Hospital, highlighted the test’s promise for simplifying diagnosis and removing a significant barrier in current diagnostics.


“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.”


The test was also predictive of patient responses during gluten challenge protocols, underscoring its utility in stratifying patients for clinical research and tailoring therapeutic strategies.


Dr Robert Anderson, co-founder of Novoviah Pharmaceuticals, current President of the International Society for the Study of Celiac Disease and a practicing gastroenterologist, said the study highlights the potential of practical, blood-based T cell diagnostics in clinic and for clinical trials.


“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,” Dr Anderson said.


The Novoleukin test’s ability to detect disease and measure changes in immune response has proven invaluable in the developmental journey for drug developers.


“Non-invasively monitoring T cell reactivity opens the door to transformative clinical applications, particularly in drug development,” Dr Anderson added.


“The platform is already being used by leading biopharma partners to evaluate immune responses during celiac disease clinical trials, offering real-time insights into treatment efficacy.”


Novoviah is actively expanding the diagnostic applications of the Novoleukin platform across additional immune-mediated diseases, including viral infection, autoimmune conditions and some cancers, aiming to bring T cell-guided insights to clinical and research settings.


The paper, Blood-based T Cell Diagnosis of Celiac Disease, was published in Gastroenterology on Tuesday 10 June 2025.


For further information, contact Dr Kylie Ellis via email.


About Novoviah Pharmaceuticals 
Novoviah is a Brisbane-based biotechnology company established in 2020 to develop and supply a new best in-class NovoleukinTM antigen-specific T cell testing platform for clinical trials and explore its broader application in clinical care. Novoviah is committed to advancing sensitive and reliable clinical tests for antigen-specific T cells to support drug developers, researchers, clinicians and patients needing better treatments and diagnosis. Find out more at www.novoviah.com


About WEHI (Walter and Eliza Hall Institute of Medical Research)
WEHI is where brilliant minds collaborate and innovate to make life-changing scientific discoveries that help people live healthier for longer. Our medical researchers have been serving the community for more than 100 years, making transformative discoveries in cancer, infection and immunity, and lifelong health. WEHI brings together diverse and creative people with different experience and expertise to solve some of the world’s most complex health problems. With partners across science, health, government, industry, and philanthropy, we are committed to long-term discovery, collaboration, and translation. At WEHI, we are brighter together. 
Find out more at www.wehi.edu.au

Diagnosis of Celiac Disease

By Katie George • July 24, 2022
Review article: Diagnosis of coeliac disease: a perspective on current and future approaches.  Summary Diagnostics will play a central role in addressing the ongoing dramatic rise in global prevalence of coeliac disease, and in deploying new non-dietary therapeutics. Clearer understanding of the immunopathogenesis of coeliac disease and the utility of serology has led to partial acceptance of non-biopsy diagnosis in selected cases. Non-biopsy diagnosis may expand further because research methods for measuring gluten-specific CD4+ T cells and the acute recall response to gluten ingestion in patients is now relatively straightforward. This perspective on diagnosis in the context of the immunopathogenesis of coeliac disease sets out to highlight current consensus, limitations of current practices, gluten food challenge for diagnosis and the potential for diagnostics that measure the underlying cause for coeliac disease, gluten-specific immunity.

Adaptive Immune Paradigm

By Katie George • June 29, 2022
Emergence of an adaptive immune paradigm to explain celiac disease: a perspective on new evidence and implications for future interventions and diagnosis. Abstract Introduction Recent patient studies have shown that gluten-free diet is less effective in treating celiac disease than previously believed, and additionally patients remain vulnerable to gluten-induced acute symptoms and systemic cytokine release. Safe and effective pharmacological adjuncts to gluten-free diet are in preclinical and clinical development. Clear understanding of the pathogenesis of celiac disease is critical for drug target identification, establishing efficacy endpoints and to develop noninvasive biomarkers suitable to monitor and potentially diagnose celiac disease. Areas covered The role and clinical effects of CD4+ T cells directed against deamidated gluten in the context of an ‘adaptive immune paradigm’ are reviewed. Alternative hypotheses of gluten toxicity are discussed and contrasted. In the context of recent patient studies, implications of the adaptive immune paradigm for future strategies to prevent, diagnose, and treat celiac disease are outlined. Expert Opinion Effective therapeutics for celiac disease are likely to be approved and necessitate a variety of new clinical instruments and tests to stratify patient need, monitor remission, and confirm diagnosis in uncertain cases. Sensitive assessments of CD4+ T cells specific for deamidated gluten are likely to play a central role in clinical management, and to facilitate research and pharmaceutical development. Click to read the full article ...

Opportunities & Milestones

By Andor Rosenberg • June 29, 2022
Society for the Study of Celiac Disease position statement on gaps and opportunities in coeliac disease.  Abstract Progress has been made in understanding coeliac disease, a relatively frequent and underappreciated immune-mediated condition that occurs in genetically predisposed individuals. However, several gaps remain in knowledge related to diagnosis and management. The gluten-free diet, currently the only available management, is not curative or universally effective (some adherent patients have ongoing duodenal injury). Unprecedented numbers of emerging therapies, including some with novel tolerogenic mechanisms, are currently being investigated in clinical trials. In March 2020, the Celiac Disease Foundation and the Society for the Study of Celiac Disease convened a consensus workshop to identify high-yield areas of research that should be prioritized. Workshop participants included leading experts in clinical practice, academia, government and pharmaceutical development, as well as representatives from patient support groups in North America. This Roadmap summarizes key advances in the field of coeliac disease and provides information on important discussions from the consensus approach to address gaps and opportunities related to the pathogenesis, diagnosis and management of coeliac disease. The morbidity of coeliac disease is often underestimated, which has led to an unmet need to improve the management of these patients. Expanded research funding is needed as coeliac disease is a potentially curable disease. Click to read the full article ...