The goal of the IBD Precision Dx project is to develop a microbiome-based diagnostic test capable of predicting disease course in Ulcerative Colitis (UC) patients, thereby supporting earlier and more targeted treatment decisions. The project is conducted in collaboration with two Scandinavian university hospitals, Akershus University Hospital (AHUS) and University hospital of Gothenburg (UGOT) and supported by funding of approximately EUR 2 million from the Research Council of Norway.

GA has now finalized the bacteria biomarker panel design freeze, marking the completion of the assay development phase. The resulting biomarker panel enables analysis of the bacterial profile in stool samples to stratify UC patients according to predicted disease severity. Testing performed using this panel demonstrates strong technical results.

GA has extensive experience in IBD research, having been actively involved in the field since 2013. Over the years, the company has built an extensive knowledge base, providing valuable insight that has played a key role in designing and conducting this IBD project, ultimately leading up to the development of the GA-map® IBD Precision Dx. The new assay will leverage GA’s proprietary GA-map® technology platform for standardized, multiplex analysis adapted on the Luminex® xMAP® technology. This approach will enable commercialization of the assay on the Luminex® xMAP® platform and make it available to laboratories and research users worldwide.

Clinical need and market relevance
IBD affects approximately 5-6 million people across the US and Europe and imposes a significant burden on patients and healthcare systems, with annual healthcare costs estimated at EUR 12–13 billion ^{1) 2)}. Beyond healthcare costs, IBD has profound impacts on patients’ quality of life, productivity, and social functioning. More than half of IBD patients are diagnosed with UC³⁾. There is a recognized need for improved tools to support personalized treatment strategies and optimize therapy selection.

Currently, no diagnostic tool exists to predict whether an UC patient will experience a mild or severe disease course. As a result, treatment optimization remains an unmet clinical need. Early administration of biologic therapy in high-risk patients is associated with better outcomes, underscoring the importance of early, precise disease course prediction. The GA-map® IBD Precision Dx test aims to fill this gap by enabling personalized treatment strategies and improved patient outcomes.

Stephan Brackmann, MD, Associate Professor Akershus University Hospital, Norway, comments:
“After collaborating closely with Genetic Analysis on this project over the past four years, we now see promising results. GA has developed an IBD test enabling clinicians to estimate the likelihood of a mild versus an aggressive UC disease course, by mapping the intestinal microbiota profile of UC patients. This is a promising step towards supporting personalized treatment strategies and improving patient outcomes.”

Ronny Hermansen, CEO of Genetic Analysis, comments:
“We are excited to report that we have now reached this significant milestone of completing the development of this new GA-map® IBD Precision Dx test targeting newly diagnosed UC patients. We are aiming to develop more tests for other IBD patient groups. Using diagnostics as an aide in personalized treatment will reduce patient sufferings and ultimately lower healthcare costs for this severe disease. We are looking forward to launch this as an RuO test in the first half of 2026.”

For further information, please contact:
Ronny Hermansen, CEO
E-mail: rh@genetic-analysis.com

References:

¹⁾ https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html

²⁾ https://pubmed.ncbi.nlm.nih.gov/38144422/

³⁾ https://www.gastroenterologyadvisor.com/factsheets/ibd-statistics/