World’s First Human Microbiome Patent for Diagnosis of Colon Disorders Awarded by European Patent Office
Potomac Falls, Virginia – June 21, 2012: Metabiomics® announced today that it has been awarded patent number EP 1815016 B1 titled “Compositions and Methods for Diagnosing Colon Disorders” by the European Patent Office (EPO). The patent is currently pending in the US and Canada based on a broader set of claims in microbiome biomarker and colon disorder diagnostic and computational methods.
The patented invention relates broadly to methods and compositions for diagnosing, monitoring, prognosticating, and analyzing gastrointestinal, polymicrobial, and autoimmune diseases based on metagenomics sequencing analysis. In particular, the invention focuses on the microbial community present in the digestive tract and lumen of patients with digestive tract diseases compared to healthy persons, especially diseases of the colon, such as inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. The patent discloses compositions and methods for diagnosing and prognosticating these colon diseases and conditions to determine the presence of the disease in a patient as well a predisposition to the disease, diagnosis of dysbiosis of the mucosal barrier that compromises the normal immune functions in the colon, the onset of active disease, and a therapeutic regimen.
Metabiomics was organized in 2011 as a spin-off of BioSpherex LLC to focus on the commercialization of this invention and other supporting next generation sequencing products and services in the emerging molecular diagnostic and therapeutic health and personalized medicine markets. As part of the spin-off, Metabiomics’ exclusively licensed this technology from BioSpherex LLC.
Dr. Patrick Gillevet, Chief Scientist of Metabiomics, points out that “Metagenomic sciences and human microbiome research has experienced explosive growth in just the past three years and is one of the most exciting and promising frontiers of scientific research today… Our goal is to contribute to the discovery and application of metagenomic knowledge to the development of diagnostic and therapeutic biomarkers and technology. In the process, we hope to solve many of the mysteries of the etiology of chronic autoimmune diseases to improved diagnostics and treatment, find new cures, and lower the costs of health care through innovations in translational and personalized medicine.”
“As the world’s first microbiome-based diagnostic patent, the general disclosures are just as important as the specific disclosures and claims”, says Dr. Thomas Kuehn, President and CEO of Metabiomics. “This patent provides us with a solid foundational position with the freedom of action to develop products and services based on our on-going pipeline of clinical research on diagnostic and therapeutic biomarkers for translational and personalized medicine applications.”
In order to accelerate the commercialization of the invention, Metabiomics is planning to raise a new round of investment capital this year to finance on-going collaborative clinical research and trials, expand it’s patent-pending MultiTag Sequencing™ laboratory and staff capacity, and commercialize our next generation sequencing and bioinformatics products and services. “We are actively negotiating new R&D Collaborations and looking for alliance partners in the Life Sciences to move our technology out of the laboratory and into the health markets”, says Dr. Kuehn. “Since the EPO was the first to issue the patent, we believe that the US will not be far behind, but we are now actively seeking a European alliance partner to commercialize this patent with our other patent-pending technology in the EU this year as a priority.”
About Metabiomics: Metabiomics® is an innovative life science company providing next generation DNA sequencing, biomarker discovery and molecular diagnostic products and services based on advances in human microbiome, metagenomics, systems biology, and bioinformatics technology. We have developed patent-pending MultiTag Sequencing™ (“MTS”), molecular diagnostic (“MDx”), and therapeutic biomarkers for translational and personalized medicine, including a patented non-invasive MDx method for colon diseases and colorectal cancer. Metabiomics products and services provide essential NGS and bioinformatics tools required for human microbiome clinical research and transitional medicine. Our technology enables significant MDx and therapeutic breakthroughs in heretofore chronic and often-incurable diseases like colorectal cancer, colon disease, autoimmune, and polymicrobial diseases. These innovations were developed over the past 10 years in collaboration with the Microbiome Analysis Center at George Mason University and many other clinical research partners with leading academic medical centers in the US and Canada. Our non-invasive MDx tests are based on multiple biomarkers that trace the etiological pathways of disease that results in the earliest possible detection, unprecedented sensitivity and accuracy, and lower costs compared to traditional tests. Metabiomics Corporation was formed in 2011 as a wholly owned subsidiary of BioSpherex LLC human to accelerate the commercialization of our pipeline microbiome technology and biomarkers in the GI, autoimmune, polymicrobial infectious disease and personalized medicine markets.
Forward Looking Statements: Any statements in this news release about future expectations, plans and prospects for the Company constitute forward-looking statements as defined in the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements, including statements about clinical trials and core operations funding, are based on Metabiomics’ management’s current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements. We caution investors that actual results or business conditions may differ materially from those projected or suggested in forward-looking statements as a result of various factors and not place undue reliance on forward-looking statements.