OSLO, NORWAY - 7 May 2026: Genetic Analysis AS ("GA" or "the Company") announces today the United States Patent And Trademark Office (USPTO) has granted U.S. patent no. 12,596,121, titled "COMPANION DIAGNOSTIC METHOD FOR USE IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIETARY INTERVENTIONS OR FAECAL MICROBIOTA TRANSPLANT". The patent covers a diagnostic method designed to assess the likelihood that patients with Irritable Bowel Syndrome (IBS) will respond to treatment with a low-FODMAP diet or Faecal Microbiota Transplant (FMT).
IBS is a common gastrointestinal disorder affecting an estimated 5-10% of the global population. Around 70% of IBS patients are associated with an altered gut microbiota composition (Dysbiosis), highlighting the need for improved diagnostic tools. This condition is associated with a significant cost burden to society, with annual direct and indirect costs in the United States estimated to approximately USD 30 billion. The Global IBS diagnostics market was estimated at USD 3.3 billion in 2025, CAGR of 5.72% during 2026-2034, and is expected to reach USD 5.4 billion by 2034 (i).
The patent family claims priority from October 14, 2016, and will be in force until November 21, 2040. The method is based on analysis of gut microbiota composition to identify specific bacterial patterns associated with treatment responsiveness. By enabling clinicians to distinguish likely responders from non-responders, the method supports more specialized and effective treatment strategies, addressing a long-standing challenge in IBS management.
This patent further strengthens the Company's intellectual property portfolio in microbiome-based diagnostics and underscores the growing importance of microbiota profiling in guiding clinical decisions.
Ronny Hermansen, CEO of Genetic Analysis, comments:
"The grant of this U.S. patent is aligned with our strategy to develop microbiome-based companion diagnostics. IBS is a condition that affects some 100 million people in US and Europe. It is vital these patients receive better diagnostic tools that can help optimizing 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".