Convenient blood test for celiac disease may cut the need for invasive testing, researchers say

09 Aug 2019 --- Distinct markers in the blood of people with celiac disease have been detected within a few hours of gluten being consumed, according to new research by specialists in the field. The new findings point to a potential technique for a more efficacious method of diagnosing the disease. The potential blood-based test would be a vast improvement on the current approach, which requires people to consume gluten for a number of weeks, and even months, for the testing to be accurate, note the researchers.

The peer-reviewed study included researchers from the Walter and Eliza Hall Institute of Medical Research in Australia, University of Oslo in Norway, and Massachusetts General Hospital and University of Chicago, US. The study was led by Boston-based biotechnology company ImmusanT.

Associate Professor Jason Tye-Din, Head of Celiac Research at the Institute and a gastroenterologist at The Royal Melbourne Hospital says that work is now underway to explore the development of the simple blood test.

“For the numerous people who follow a gluten-free diet without a formal celiac disease diagnosis, all that might be required is a blood test before, and four hours after, a small meal of gluten,” he explains. 

Tye-Din adds that this would be a dramatic improvement on the current approach, which involves undergoing an invasive procedure to sample the small intestine.This comes after patients are asked to actively consume gluten for at least several weeks prior to the procedure.

Celiac disease affects approximately 1.4 percent of people globally, many of whom remain undiagnosed, the scientists note. Symptoms of the disease are caused by a damaging immune response to gluten. After consuming gluten, patients can experience reactions such as nausea, vomiting, abdominal pain and diarrhoea.

Bob Anderson, Ph.D., a joint senior author of the paper and the Chief Scientific Officer of ImmusanT , says the new findings could address an important medical need. “For the first time we have described the inflammatory reaction that patients with celiac disease experience in the immediate hours after they are exposed to gluten.”

"The unpleasant symptoms associated with the disease are linked to an increase in inflammatory molecules in the bloodstream, such as interleukin-2 (IL-2), produced by T-cells of the immune system. This response is similar to what happens when an infection is present, however for people with celiac disease, gluten is the trigger,” he outlines.

This information underpins a potential new approach to diagnosis. It addresses the emerging medical need to identify patients without celiac disease who may be better served by other treatments for their chronic symptoms, the senior author notes.

Researchers at ImmusanT first discovered the immune markers while assessing blood samples during the Phase 1 trial of a potential celiac therapy called Nexvax2. Gastrointestinal symptoms in patients injected with the gluten peptides, particularly nausea and vomiting, correlated with higher levels of IL-2 in their blood.

Subsequent testing showed the consumption of gluten produced the same IL-2 response in people with celiac disease.

The CEO of Celiac Australia, Michelle Laforest, says the finding would be welcome news for the celiac community in Australia. “The potential for a one-off gluten challenge and blood test could make a significant difference to many thousands of Australians who report sensitivity to gluten but have been unable to tolerate the current testing approach.”

“It is clear that this research has the potential to revolutionize the current testing regime for celiac disease globally,” Laforest concludes.

Combatting celiac
More research into celiac disease is in the pipeline, with modern biotechnology being explored. Potentially, gluten could be entirely removed from the wheat genome or other target. Additionally, a removal of “toxic” epitopes from the gluten protein could be possible. In this method, gluten retains its unique baking characteristics, but does not trigger an autoimmune response in celiacs, according to University of Wageningen researchers. 

To date, the most common strategy in treating symptoms of celiac disease is a strict, lifelong gluten-free diet, which can be challenging to follow. However, the use of gene editing tool CRISPR/Cas9 could present future opportunities, say the researchers.

The world's first vaccine for celiac patients, Nexvax2 from ImmusanT., secured fast-track designation from the US Food and Drug Administration (FDA) in the first half of this year. The FDA grants fast-track status to certain investigational drugs to expedite the development and review process for therapeutic candidates with the potential to fulfill the unmet needs of patients with serious or life-threatening conditions.

In June, UK charity Coeliac UK and innovation agency Innovate UK offered a sum of £180k (US$229k) towards funding research into celiac disease. The partners are encouraging UK businesses and researchers to apply, and total project costs can range from £50k (US$65K) to £250k (US$318k).

By Benjamin Ferrer