Genetic Analysis GA-map® enables cost-efficient and reliable mapping and profiling of gut microbiota via In Vitro Diagnostics (IVD) testing. Genetic Analysis is currently the only company globally that offers a patented and CE-marked standardized testing platform for microbiome analysis, the GA-map® Dysbiosis Test. GA has initiated an ambitious growth plan to rapidly grow the business over the next few years in the EU and US. We have proven our existing business model to molecular labs, and the Company is now ready, with the CE-marked GA-map®, to be commercialized in the current market for microbiota testing as well as to enter the market for companion diagnostics, where the test will be performed in combination with microbiota altering drugs. The growth plan will expand the commercialization through carefully selected distributors for vast expansion and strategic direct sales of the current product portfolio within Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD). Based on the competitive advantages that a standardized diagnostic platform will have in the microbiota field, compared to the current research-based tools, and the huge number of potential patients, we assess that the market for GA’s technology is significant.

GA accomplished essential milestones during the period by being granted patents in US, Japan, India and the EU. In June, we successfully completed the next generation of the GA-map® Dysbiosis Test with a CE mark. The next generation includes a built-in bacteria functionality reporting algorithm that will further reduce run-time for the lab. We expanded our distribution network with Eagle Bioscience in the US and reached a significant agreement with a lab chain in Germany to sell the GA-map® platform installation package. Finally – GA, together with the Norwegian University of Life Sciences, is developing the world’s first complete database of reference genomes, HumGut, a collection of about 30,000 genomes, covering the broad diversity of bacterial genomes found in the human gut. Mapping and unlocking the genes present in a healthy gut is instrumental for developing new diagnostics and better treatment regimes. We will actively use this powerful search engine and database to identify novel gut signatures which we can plug onto our GA map® technology platform to develop new innovative diagnostic markers within the microbiome field.