A less invasive, more comprehensive test for diagnosis of Coeliac Disease

August 25, 2021. Reviewed by Victoria Simms, April 23, 2024.

Coeliac Disease: developing a less invasive test for diagnosis


Using immune repertoire profiling to test for coeliac disease

What stage is the project in?

In the initial phase of the project, Nonacus used a DNA Mastermix template (consisting of DNA extracted from a number of fresh blood and frozen tissue samples including lymph node, duodenum, colon and spleen and provided by Cambridge University) to develop and optimise the laboratory process by using a series of experiments to determine which set of probes and which order, gives the best results. The diversity of each sample was assessed as total number of unique CDRs an important measure of the success of the process.

The second phase of this project was to determine the minimum DNA concentration at which maximum diversity may be achieved. The third phase was to determine the performance of this double capture-based strategy on samples with a normal level of polyclonality, rather than the 'hyper-polyclonal' mastermix template.

How many samples have been processed?

To date 231 samples have been processed through this novel method which has been developed. These are a mix of control samples, duodenal biopsies from Coeliac Disease patients and blood samples from Coeliac Disease patients.

It has been shown that the method works on controls and duodenal biopsy and Nonacus have now also processed a large number of blood samples which is where the biggest benefit comes from if a minimally invasive blood test can be offered to Coeliac patients. The University of Cambridge are now analysing this data to see if there is a clear signal from the blood samples from Coeliac patients versus control patients samples.

Nonacus will also be processing another 174 duodenal biopsy samples to confirm that the method is truly robust for discerning Coeliac patients versus control (non-Coeliac patients) when analysing Duodenal biopsy. This testing method also brings benefits owing to the fact that it will not require Coeliac patients on a gluten-free diet to take gluten prior to testing and it will also provide a much clearer yes/no answer versus the current histopathology investigation of duodenal biopsies on slides.

Why has the project been delayed?