Development and validation of a minimally invasive comprehensive diagnostic Coeliac Disease test

 

Developing a less invasive and comprehensive test for diagnosis of coeliac disease.  

In coeliac disease, lymphocytes (a type of white blood cell) attack tissues in the gut. It has been shown that part of the DNA of each lymphocyte is unique, so researchers wanted to find and read these unique parts as a method of diagnosing coeliac disease.  
Researchers hoped to develop laboratory based methods for diagnosing coeliac disease with a computer system to analyse results. Ideally, without the patient needing to consume gluten or having to have an endoscopy and biopsy.  

What was done? 

Researchers looked at DNA in blood samples and duodenal biopsies obtained from the Cambridge University Hospitals Human Tissue Research Biobank. They compared samples from people diagnosed with coeliac disease and people who did not have a diagnosis of coeliac disease.  

What are the next stages for this research?  

The project successfully created a cheaper and simpler method of finding lymphocyte DNA sequences, but unfortunately, this method did not find enough lymphocyte DNA sequences in each sample to give an accurate diagnosis. Therefore, researchers need to work on different approaches to analyse lymphocyte DNA sequences.

What does this research mean for the coeliac / gluten-free community?  

The research has created a greater understanding of what needs to be obtained from a patient sample for an accurate diagnosis of coeliac disease using this method. Progress was made on the methods for analysing lymphocyte DNA sequences. When a more suitable laboratory method for obtaining these DNA sequences from patient samples is identified, a new diagnostic test could be developed that does not require gluten consumption.  

How has the funding from Coeliac UK and Innovate UK made a difference to this research?  

The funding has allowed research to move a long way down the road of looking at methods to use lymphocyte DNA in diagnostics, both in understanding how many sequences we need to obtain from each patient sample and also how to analyse those sequences. 

The initial funding has also primed further funding and the researchers of this project have been awarded a £5 million grant as this new method of analysing lymphocyte DNA shows significant promise in exploring lymphocytes in cancer research. 

Project Title: Development and validation of a minimally invasive comprehensive diagnostic Coeliac Disease test  

This grant was jointly funded by Coeliac UK and Innovate UK. Innovate UK is an organisation within the UK government’s national research and funding agency that invests in science and research.  

Non-invasive diagnostic tests, developed by industry partner Nonacus, were used in this research. 

The project ran from April 2019 - December 2021.  

Duration: 31 months 

Grant: £197,494