A new Australian study may revolutionize how coeliac disease is diagnosed, particularly for individuals already following a strict gluten-free diet. The research showcases a new blood test that can detect coeliac disease with high accuracy, without requiring patients to consume gluten beforehand, a major hurdle in current diagnostic procedures.
Coeliac disease is an autoimmune condition affecting around 1% of people in Western countries, where gluten consumption triggers an inflammatory response in the small intestine. Presently, diagnosis relies on either a blood test or a gastroscopy, but both require the patient to reintroduce gluten into their diet for several weeks. This often causes symptoms such as diarrhea, abdominal pain, and bloating, discouraging many from seeking a formal diagnosis.
Dr. Jason Tye-Din, senior author of the study and head of the Coeliac Research Laboratory at the Walter and Eliza Hall Institute (WEHI), said this difficulty in diagnosis has left many cases unrecognized. “Millions of people may be unknowingly living with coeliac disease because the diagnosis process is so burdensome,” he noted. The new test, he added, could be a “game-changer” for clinical practice.
Understanding the New Diagnostic Approach
The test works by measuring interleukin-2 (IL-2), an immune marker that spikes in the blood shortly after gluten is introduced in individuals with coeliac disease. Researchers from WEHI tested blood samples from 181 participants aged 18 to 75, including those with diagnosed coeliac disease, non-coeliac gluten sensitivity, and healthy controls.
The process involved mixing gluten into the participants’ blood samples and measuring whether the IL-2 signal appeared. Using a system developed in collaboration with Novoviah Pharmaceuticals, the test achieved up to 90% sensitivity and 97% specificity, even for patients who had been on a gluten-free diet for at least a year.
Lead author Olivia Moscatelli, who herself was diagnosed with coeliac disease at 18, emphasized the potential of the test to simplify diagnosis significantly. Novoviah Pharmaceuticals, although involved in developing the technology, did not influence the research process or data analysis. The company aims to bring the test into clinical use within two years.
Expert Reactions and Future Directions
While the test has drawn praise from medical experts, some caution that further studies are needed. Professor Peter Gibson, a gastroenterologist at Monash University, described the research as “high quality” and the results as “very impressive.” He also noted that the simplicity of the test could allow for easy adoption in standard labs.
However, Associate Professor Vincent Ho of Western Sydney University pointed out the study’s limitations, including its small sample size and lack of diversity in participants. He also noted that patients on immunosuppressive medications may not show the required immune response, limiting the test’s applicability.
Ho stressed the need for additional validation in larger, multi-center studies and said the test must also prove to be cost-effective. Nonetheless, the idea that a single dose of gluten could trigger a detectable immune response represents a significant leap forward. “In theory,” he said, “this means coeliac disease could be diagnosed without prolonged gluten exposure.”
Experts agree that with further development, this innovation could mark a major shift in how coeliac disease is diagnosed, making the process faster, less invasive, and more accessible for millions worldwide.
