Genetic Analysis: Awarded important EU patent covering a companion diagnostic method for optimising IBS interventions

OSLO, NORWAY – 13 June 2024: Microbiome DX company Genetic Analysis AS (“GA” or “the Company”) announces today the grant of an important patent (EP3526340) by the European Patent Office (EPO) entitled “A COMPANION DIAGNOSTIC METHOD FOR USE IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIETARY INTERVENTIONS OR FAECAL MICROBIOTA TRANSPLANT”. The invention covered provides a diagnostic method to be used to determine the likelihood that a patient with Irritable Bowel Syndrome (IBS) will respond to treatment with a low-FODMAP diet or Faecal Microbiota Transplant (FMT). In 2021, the company obtained the same patent in the USA and thus now has patent protection in two important markets.

The patent family claims priority from 14th October 2016 and will be in force until October 2037. GA will bring the granted patent into force in major European countries and is part of the Company’s active patent strategy covering all major geographical markets. It further strengthens the Company’s strategic commitment to developing innovative non-invasive diagnostic tools with high applicability to different stakeholders in the healthcare sector.

IBS is one of the most burdensome conditions characterised by abdominal pain or discomfort in 5-10% of people globally or 10-15 % of people in Western hemisphere. Around 70% of IBS patients have a disturbed microbiota (Dysbiosis) and the need for improved diagnostics is imminent. The GA-map® Dysbiosis Test is used to identify and categorise the severity of the dysbiosis and to exclude non-dysbiotic patients. Thus, offering specialists a tool to personalise the treatment of these patients.

This condition represents huge patient suffering and significant cost burden to society. Annual direct and indirect costs to society are estimated to US$ 21 billion in US alone. The Global IBS diagnostics market was estimated at US$ 2,5 billion in 2020, CAGR of 5.9%, and is expected to reach USD 3,9 billion by 2028 ([i]).

Ronny Hermansen, CEO of Genetic Analysis, comments:

“We are delighted to announce that our patent “A companion diagnostic method for use in the treatment of irritable bowel syndrome (IBS) with dietary interventions or faecal microbiota transplant” was granted in Europe. IBS is a condition that affects 80 million people in US and Europe. It is vital these patients receive better diagnostic tools that can help optimise current treatment regimes. The approval further strengthens our intellectual property portfolio and is an important milestone in GA´s focus on developing companion diagnostics that use gut microbiota signatures to improve treatment outcomes”.