Getting diagnosed with celiac disease shouldn’t require making yourself sick. Yet for decades, that’s exactly what many patients have had to do. Reintroduce gluten into their diet, endure symptoms, and undergo invasive procedures, all in the name of getting answers. At the Celiac Disease Foundation, we’ve long advocated for better, safer, and more accurate diagnostic tools. And now, thanks to groundbreaking new research, that future is within reach.
A recently published study in Gastroenterology features a first-of-its-kind blood test that can detect celiac disease even in people who are already on a gluten-free diet. Developed by researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Australia and Novoviah Pharmaceuticals, the test identifies an immune system marker called interleukin-2 (IL-2), which spikes when blood from someone with celiac disease is exposed to gluten in a test tube.
The test demonstrated up to 90% sensitivity and 97% specificity in identifying celiac disease—without requiring people to eat gluten. For the millions of people around the world struggling to get a diagnosis without compromising their health, this is a potentially life-changing advancement.
“This test has the potential to completely change how we approach diagnosis,” said Associate Professor Jason Tye-Din, Head of the Coeliac Research Laboratory at WEHI. “It removes one of the biggest roadblocks for patients and offers a new, less invasive, more compassionate way to confirm celiac disease.”
Dr. Bob Anderson, President of the International Society for the Study of Coeliac Disease, co-founder of Novoviah Pharmaceuticals, and Principal Science and Innovation Advisor to the Celiac Disease Foundation, emphasized the significance of the work.
“This test is the culmination of decades of research into how gluten-specific T cells drive celiac disease. It’s incredibly exciting to see that science now being applied to solve one of the biggest challenges patients face: getting diagnosed without reintroducing gluten.”
Dr Anderson continued saying, “Individuals might question whether they have celiac disease but there has been no convenient medical test for those already on a gluten-free diet. The Novoleukin-C test system has the potential to identify people who should remain on gluten free diet, and those who could potentially reintroduce gluten without negative health effect.T he Novoleukin-C test system has already been incorporated in many clinical trials of experimental therapies for coeliac disease. I am delighted that many years of immunology research in coeliac disease has delivered a testing system that could speed diagnosis and also benefit people who unnecessarily avoid gluten.”
Bringing the Innovation to the U.S.
The Celiac Disease Foundation is proud to be advancing this promising diagnostic tool through research partnerships with two of the top pediatric celiac programs in the United States. Studies are currently underway at Boston Children’s Hospital, led by Dr. Jocelyn Silvester, and at Children’s Hospital Colorado, led by Dr. Marisa Stahl. These efforts are focused on validating the IL-2 test’s performance across diverse U.S. populations and clinical settings, with the goal of making it a widely available option in routine care.
Looking Ahead
With up to 80% of people with celiac disease remaining undiagnosed worldwide, the need for more accessible and less invasive testing methods has never been greater. The IL-2 test has shown promise not only in confirming diagnoses but also in predicting the severity of an individual’s reaction to gluten—all without requiring a gluten challenge.
Importantly, the test has also demonstrated reliability in patients with coexisting autoimmune diseases, avoiding the false positives that can complicate other diagnostic tools. Its ability to detect immune activity at extremely low levels is paving the way for a more precise and personalized approach to celiac care.
The Celiac Disease Foundation is honored to play a role in supporting the science that is shaping the future of diagnosis. We look forward to continued collaboration with leading researchers and institutions to ensure that this innovation reaches the patients who need it most.