New Blood Test Offers Accurate Celiac Disease Diagnosis Without Gluten

A groundbreaking blood test developed by researchers at the Walter and Eliza Hall Institute and the University of Melbourne promises to revolutionize the diagnosis of celiac disease by eliminating the need for patients to consume gluten. Published on June 9, 2025, in the journal Gastroenterology, this innovative test detects celiac disease with high sensitivity and specificity, even in individuals who have not ingested gluten.

Celiac disease is an autoimmune disorder triggered by gluten, a protein found in wheat, rye, and barley. The only effective treatment for those diagnosed is a strict, lifelong gluten-free diet. Despite its prevalence, estimated at 1-2% globally, a significant number of cases—between 50% and 80%—remain either undiagnosed or diagnosed late due to the challenges associated with current diagnostic protocols, which require gluten consumption.

Dr. Olivia Moscatelli, a PhD candidate at the Tye-Din Lab, emphasized the significance of this development, stating, "This is a simple and accurate test that can provide a diagnosis within a very short time frame, without the need for patients to continue eating gluten and feeling sick, or to wait months for a gastroscopy."

The research team previously discovered that interleukin-2 (IL-2) levels spiked in the blood of individuals with celiac disease after gluten consumption. Building on this finding, they developed a whole blood assay measuring IL-2 release to detect gluten-specific T cells. The study involved blood samples from 181 participants, which included individuals with diagnosed celiac disease, nonceliac gluten sensitivity, and healthy controls. Remarkably, the new IL-2 assay demonstrated a sensitivity of 90% and specificity of 95% in patients with the HLA-DQ2.5 genotype, and a sensitivity of 56% for those with HLA-DQ8 celiac disease.

Christopher Cao, director of the Celiac Disease Program at the Mount Sinai Health System in New York City, hailed the test as "welcome and practice-changing." He noted the difficulties faced by patients required to undergo a gluten challenge—a process that involves consuming 1-2 slices of bread daily for six weeks, which can be particularly distressing for those already adhering to a gluten-free diet. However, he also stressed the necessity for further large-scale, multicenter studies to ensure the test's generalizability and effectiveness across varied populations.

Plans for future research include assessing the IL-2 whole blood assay's performance in pediatric cohorts and in international settings to validate its efficacy across diverse populations. The test aims to potentially replace the invasive gastroscopy currently used as a confirmatory measure following positive serological tests. The commercialization of the test is being managed by Novoviah Pharmaceuticals, with plans for clinical implementation anticipated within the next two years.

Overall, the introduction of a blood test that accurately detects celiac disease without the need for gluten consumption represents a significant advancement in the field of gastroenterology. This innovation could lead to earlier diagnosis and treatment for many individuals, improving their quality of life and health outcomes. As Dr. Moscatelli stated, the test's ability to predict patient reactions to gluten without actual ingestion could transform the diagnostic landscape for celiac disease, making it accessible to a broader patient population than ever before.