On November 17th, Genetic Analysis AS (“Genetic Analysis” or the “Company”) announced a milestone for the Company’s ongoing IBD Precision Dx project, where the biomarker panel development now has been completed. This means that the next and final step before launch, expected in H1-26, is the final validation phase and completion of software development.
Analyst Group’s View of the News
Genetic Analysis has previously communicated an anticipated completion of a Research Use Only (RuO) version of GA-map® IBD Dx, a new innovative biomarker for Inflammatory Bowel Disease (IBD), by Q4-25 and with the announced milestone, a commercialization, expected during H1-26, is getting closer. GA-map® IBD Dx is a microbiome-based diagnostic tool to predict disease progression and treatment response in IBD, enabling earlier and more personalized treatment. Supported by the Research Council of Norway, the project involves the University of Gothenburg and Akershus University Hospital. The new assay will leverage Genetic Analysis proprietary GA-map® technology platform for standardized, multiplex analysis adapted on the Luminex® xMAP® technology, widely used in laboratories globally.
Like other areas in which Genetic Analysis is involved, the current diagnostic instruments within the IBD field are considered insufficient, leaving a gap in the market for the Company to fill. No current diagnostic method can determine whether a patient with UC will develop a mild or severe disease trajectory, leaving a significant unmet need for improved treatment stratification and optimization. The GA-map® IBD Precision Dx test is designed to address this need by supporting personalized treatment decisions and improving patient outcomes.
The global human microbiome market is expected to grow rapidly in the coming years, Global Market Insights estimates an annual growth rate of 20.9% until 2034, where the primary growth driver is expected to be advances in research, which have revealed the microbiome’s potential in therapeutics. As therapeutics become more readily available, the need for reliable diagnostic tools is expected to grow in tandem. Thus, Analyst Group argues that the microbiome market is expected to shift towards a more diagnostic approach, where Genetic Analysis has an established first mover advantage within microbiome-based diagnostics through the patented platform GA-map®.
GA-map® IBD Precision Dx will add a new product to the portfolio, thereby contributing to growth of recurring and high-margin reagent kit sales, which is expected to drive growth and margin expansion for Genetic Analysis. Nevertheless, adaptation of the test and a market shift towards a more diagnostic approach is expected to require time, which is why installations at new laboratories are not expected to accelerate exponentially but grow steadily. However, the overall market trend is expected to create a long-term growth runway for Genetic Analysis, which supports the expectation that new installations will continue to grow over an extended period. With a larger installed base, the Company is expected to expand the recurring revenue from high-margin reagent kits, which historically is primarily related to the Company’s largest product, GA-map® Dysbiosis Test.
In conclusion, Analyst Group views the announced milestone in the GA-map® IBD Precision Dx project as an important step toward commercialization and a strong validation of Genetic Analysis’ technological progress. With the biomarker panel now completed, the Company is entering the final validation phase ahead of the planned Research Use Only launch during H1-26. The test addresses a significant unmet need within the IBD field by enabling earlier and more personalized treatment decisions, strengthening Genetic Analysis’ position in the rapidly growing microbiome diagnostics market. As part of the expanding GA-map® portfolio, IBD Precision Dx is expected to contribute to increasing high-margin recurring revenues and support long-term growth, reinforcing the Company’s first-mover advantage within microbiome-based diagnostics.
