TCR sequencing method for diagnosing celiac disease without gluten challenge or biopsy

BUSINESS OPPORTUNITY

Scientists at Oslo University Hospital and University of Oslo have identified a repertoire of celiac disease (CeD) associated T-cell receptors which preliminary data indicate could have a potential as a diagnostic method for CeD. This research is led by prof. Ludvig Sollid, a world-leading scientist within the field of CeD

Inven2 AS seeks partners for co-development and/or licensing of the technology. We are interested to get in touch with pharma or diagnostic companies to discuss the possibilities for the method and the potential for collaboration.

TECHNOLOGY

Extensive research led by prof. Sollid has shown that the gluten-specific TCR clones persist for decades and that identical TCR sequences are found in the gluten-specific TCR repertoire of different celiac disease patients¹. These shared (“public”) TCR sequences represent potential diagnostic markers for celiac disease.

The researchers have conducted a pilot study using high throughput TCR sequencing on blood samples from a small group of patients. This study established the proof-of-principle of utilizing the set of public TCR sequences as diagnostic markers. Funding for a lager clinical study and access to around 300 patients’ samples has been secured. The aim of this study is to establish a robust estimate of the diagnostic accuracy required to determine clinical utility.

ADVANTAGE

There is an unmet need in the market for a test positioned in secondary diagnosis, between the first-line serology tests and the definite diagnostic test based on highly invasive endoscopy following a long-term gluten challenge. Our proposed test can detect CeD based on a blood sample and without the need for gluten challenge. This may be an attractive option for suspected celiac patients who are not willing to undergo the procedure required for a clear diagnosis according to current standards.

The test has the potential to give a broader picture of the disease and could be used for patient monitoring in assessing treatment response to CeD.