Metabiomics Executive Summary
Metabiomics is developing a revolutionary non-invasive test for earlier and more accurate detection of colon polyps and colorectal cancer (CRC) based on human microbiome biomarkers. We have developed patented technology that integrates advances in microbial ecology, next-generation DNA sequencing, and computational systems biology that enables us to detect CRC and colon polyps by sequencing the microbial DNA in stool samples. Our approach is not only novel and accurate; it is also extremely cost effective due to advances in next-generation sequencing in combination with proprietary and patented sequencing and analysis methodology.
Colorectal cancer is one of the most preventable yet least prevented cancers. The global colorectal cancer screening market is estimated to be $7.5 Billion per year. In the U.S., 14.5M screening tests are performed annually of which approximately 4.3M are colonoscopies and 10.2M are fecal occult blood tests. Screening programs designed for early detection of cancer as well as prevention by polyp removal followed by surveillance have demonstrated an impact on colon cancer mortality, Unfortunately, 47% of American's do not comply with current Public Health screening recommendations. Colonoscopy is very accurate but is invasive and expensive and still does not address the high rate of interval cancers, i.e. cancers that develop after a negative colonoscopy. Fecal occult stool testing is simple, but compliance rates are low and FOBT's are not accurate for pre-cancerous polyps. Therefore, there is a significant need for a simple, non-invasive test that can be used to identify patients who have colon cancer or are at risk for developing cancer because they have pre-cancerous polyps.
Value Proposition: Our CRC test delivers the benefits of low cost, high accuracy, non-invasiveness, and early detection. Augmenting an expensive and invasive procedure with a non-invasive, easy-to-use test, that can accurately detect both precancerous colon polyps and cancer will benefit insurance companies, physicians, and patients. With increased screening adherence and reliable detection of colon polyps, CRC can be prevented.
How it works: Our assay can detect colon polyps and early stage colorectal cancer by detecting microbial biomarkers that are a functional link between bacterial dysbiosis and carcinogenesis. In other words, by characterizing the disruption of the microbiome that is associated with inflammation, polyps, and colorectal cancer and by sequencing the microbial DNA from rectal swabs or stool samples we can detect adenomas and adenocarcinomas.
1. The Human Microbiome: Metabiomics is a pioneer in the new frontier of human microbiome diagnostics. We have been issued the world's first microbiome-based biomarker patent in Europe (advanced stage US) and a DNA sequencing patent in US (advanced stage EU). We have analyzed over 5,000 clinical samples associating the microbiome with several different GI diseases. In addition to our CRC molecular diagnostics (MDx), we have an MDx pipeline that includes IBS, IBD, chronic liver disease, and other GI and autoimmune diseases.
2. Colorectal Cancer Biomarkers: Microbiome biomarkers are the best predictor of the presence of colon polyps and CRC because the microbiome is extraordinarily sensitive to changes associated with the presence of adenomas and carcinomas in the gastrointestinal tract.
3. Next-Generation Sequencing: Our MultiTag™ Sequencing platform utilizes diagnostics-grade sample multiplexing/batch processing of microbial DNA/RNA to achieve a significant operating and capital cost advantages over colonoscopy and the latest generation of molecular diagnostics. This technology base is inherently capital efficient and scalable. For example, during the market introduction phase we will be able to perform more than 20,000 tests per year with each NGS instrument.
We are bringing our CRC test to market initially as a CLIA laboratory-developed test (LDT) rather than starting with the longer and more costly FDA clinical trial route. We plan to use our own CLIA certified laboratory for the clinical validation study and initial market penetration. The laboratory will utilize a highly automated sample preparation, analysis and reporting platform
Our CLIA laboratory will initially service our existing network of clinical partners and medical center collaborators. We will outsource our sales and marketing as well as billing and reimbursement in order to optimize the value generated by our core competencies in DNA sequencing technology, computational biology, bioinformatics, and laboratory information management.
We will also expand quickly into global markets by making regional licensing and distribution deals. We have recently forged a partnership with Kindstar Global, a large Chinese specialty-testing laboratory that services over 3,300 hospitals across China. This first regional deal represents a highly scalable model in which the partnering company will perform sample collection and DNA sequencing and Metabiomics will perform “computational diagnostics” and reporting via our cloud microbiome analysis portal, which we will scale up using available low cost cloud computing servers. This arrangement maximizes Metabiomics’ profitability while protecting our intellectual property.
Metabiomics has been self-financed by its co-founders and >$1.5M in non-dilutive R&D grants and collaborative research revenues over the past five years. Our first financing will be used to execute several pivotal clinical studies, prosecute patents, hire key management and staff, and develop marketing, sales, and distribution channels. A second financing round is planned to finance CLIA laboratory provisioning and certification, clinical validation and clinical utility studies of the CLIA laboratory developed CP-CRC test, market introduction, marketing, and sales growth, as well as CMS and insurance payer reimbursement approvals. Additionally, our current and planned concurrent investments from our strategic alliances for clinical research studies in the U.S. and from Kindstar for costs of clinical validation studies and market development in China are estimated to rapidly increase in value over the next three years.
The Metabiomics management team has been expanded in 2013 and includes extensive and diverse life sciences, biotechnology, clinical research, technology innovation, business development, and company management experience and expertise.
Metabiomics Safe Harbor Statement: This web page 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.