World-first blood test transforms coeliac disease diagnosis

Brisbane-based biotechnology firm, in partnership with the Walter and Eliza Hall Institute of Medical Research (WEHI), has pioneered a world-first blood test for coeliac disease that bypasses the need for patients to undergo weeks of gluten consumption – a process that exacerbates their symptoms.

Coeliac disease, a prevalent autoimmune condition triggered by gluten from wheat, rye, and barley, affects over 350,000 Australians. Despite its prevalence, up to 80% of cases remain undiagnosed, largely due to the challenging diagnostic protocols.

Current methods such as serology blood tests or intestinal biopsies are unreliable for individuals on a gluten-free diet, necessitating gluten intake to yield accurate results. This requirement discourages many from seeking definitive diagnosis as eating gluten makes the person physically sick.

Associate Professor Jason Tye-Din, Head of WEHI’s Coeliac Research Laboratory and a gastroenterologist at the Royal Melbourne Hospital, said “This new test promises to simplify and speed up accurate diagnosis, while also avoiding the suffering that comes with eating gluten for extended periods to reactivate coeliac disease. By eliminating the need for a gluten challenge, we’re addressing one of the biggest deterrents in current diagnostic practices.

“This test could be a game-changer, sparing thousands of people the emotional and physical toll of returning to gluten. It’s a major step towards faster, safer diagnosis.”

PhD researcher Olivia Moscatelli, diagnosed with coeliac disease at 18, commented “This breakthrough is deeply personal as it could spare others from the gruelling diagnostic process I had to endure. Knowing I’ve played a role in this achievement is a powerful, full-circle moment.”

The test’s development stemmed from WEHI’s 2019 discovery, in collaboration with Dr Robert Anderson, co-founder of Novoviah Pharmaceuticals, identifying interleukin 2 (IL-2) as a key immune marker that surges post-gluten ingestion in coeliac patients.

In a recent study involving those with treated coeliac disease, untreated cases, non-coeliac gluten sensitivity, and healthy controls, the blood test demonstrated up to 90% sensitivity and 97% specificity, even in gluten-free individuals.

Dr Anderson, President of the International Society for the Study of Coeliac Disease, gastroenterologist at Mackay Base Hospital and co-founder of Novoviah Pharmaceuticals, said  “I have been delighted to have a close and exceptionally productive collaboration with Professor Tye-Din that launched innovative therapies and now diagnostics harnessing the gluten-specific T cells we obsessively characterised in studies over the past 25 years.”

Moscatelli highlighted the test’s broader application beyond coeliac disease, saying “Its performance in individuals with other autoimmune conditions in addition to coeliac disease, such as type 1 diabetes or Hashimoto’s thyroiditis, is also unmatched. Some diagnostic tests give false positives in the presence of other autoimmune diseases, but this was not an issue for this test.”

The research, supported by Coeliac Australia, Novoviah Pharmaceuticals, and several foundations, aims to validate the test’s efficacy across diverse populations, heralding a paradigm shift in coeliac disease diagnosis.

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