POTOMAC FALLS, VA, December 10, 2013
Metabiomics is pioneering the development of molecular diagnostic tests for colorectal cancer, inflammatory bowel disease, and other gastrointestinal cancers and autoimmune diseases built on an exclusive worldwide license from BioSpherex LLC enabling next-generation sequencing (“NGS”)-powered metagenomics analyses of the human microbiome. The award today of US Patent 8,603,749, MutiTag Sequencing for Ecogenomics Analysis, represents a major milestone for Metabiomics by providing exclusive rights to fundamental next generation sequencing analysis technology for multiplexed ‘barcoded” sequencing of nucleic acids from multiple samples in high-throughput analysis in the field of gastrointestinal diagnostics and therapeutic biomarker discovery. Dr. Thomas J. Kuehn, President and CEO of Metabiomics, emphasized that “the award of the MultiTag™ Sequencing patent in the US will accelerate our translational diagnostics clinical trial program to advance both our metagenomic colorectal cancer and IBD assays and in-vitro diagnostics (IVD’s) by providing freedom of action and exclusive patent protection for barcoded next-generation sequencing.”
The MultiTag™ Sequencing system separately ‘barcodes’ multiple samples of nucleic acids using fusion primers for PCR, followed by pooling the amplified samples and sequencing the pool. Dr. David Hanzel, President and COO of Metabiomics, explains that “MultTag™ sequencing is a multiplex method for determining abundance profiles of one or more target polynucleotide sequences across a plurality of samples by amplifying and tagging target polynucleotides by PCR in each of the samples with an amplification fusion primers that include an NGS high throughput sequencing adapter, a sample-specific tag sequence of at least four nucleotides in length, and a priming sequence to amplify said target polynucleotide sequence. By combining the amplified polynucleotides and sequencing the polynucleotide pool in high throughput sequencing instruments and assigning the nucleotide sequences to the originating samples by the nucleotide sequence of the sample-specific tag, it is possible then to compute the abundance profiles of the target polynucleotide sequence(s) across the samples.”
The MultiTag™ sample barcoding technology enables methods and kits for unbiased PCR amplification and abundance profiling of sequences, reduced cost from pooled sequencing of multiple samples per NGS run, and increased throughput for nucleic acid sequencing services, including molecular diagnostic tests. Dr. Kuehn stated that, “Since it’s invention a decade ago, MultiTag™ Sequencing has become an essential tool in every high throughput next generation sequencing laboratory.”
The patented MultiTag™ sequencing technology is widely used in NGS laboratories today for both genomic and metagenomic research and molecular diagnostics and is a foundational technology that represents a significant advance in the industry. Dr. Kuehn also announced that “Because MultiTag barcode sequencing is so fundamental to genomic and metagenomic research and diagnostics, Metabiomics Corp. and BioSpherex LLC have agreed that they will make this technology available for exclusive and non-exclusive out-licensing for academic research, sequencing services, and commercial use in the industry.”
Metabiomics Corporation is an early-stage, diagnostics company that is developing non-invasive screening tests for gastrointestinal and autoimmune diseases based on human microbiome biomarkers. The company has developed/licensed patented/patent-pending technology that integrates advances in microbial ecology, next-generation DNA sequencing, and computational systems biology. These innovations were developed over the past 10 years in collaboration with Dr. Patrick Gillevet, Vice President and Chief Scientific Officer of Metabiomics, at the Microbiome Analysis Center at George Mason University and many other clinical research partners at leading academic medical centers in the US and Canada. Metabiomics was formed in 2011 as a wholly owned subsidiary of BioSpherex LLC to focus on molecular diagnostic application of human microbiome research in translational medicine.
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Metabiomics Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential results and future outcomes our clinical research and business plan; ability to discover biomarkers and diagnostic tests; our beliefs regarding the need for and value of molecular diagnostics; and the focus and attributes of the company’s product pipeline, including the ability of the company’s tests to impact clinical practice. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical and developmental studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and the timing thereof; unanticipated costs or delays in research and development efforts; the applicability of initial next generation sequencing studies to future results; the risk that we may not obtain or maintain reimbursement for diagnostic tests we may develop, both domestically and abroad; our ability to compete against third parties; the risks and uncertainties associated with the regulation of our tests by the FDA and other agencies abroad; and the other risks set forth in the company’s business plans and presentations. These forward- looking statements speak only as of the date hereof. Metabiomics disclaims any obligation to update these forward-looking statements.