Biomarker Discovery Platform PCMAT™, an Innovative Platform for Identification of Biomarkers to Diagnose Cancers and Other Diseases
BackgroundOragenics’ Proteomics-based Change Mediated Antigen Technology (PCMAT™) uncovers biomarkers in body fluids (blood, saliva or urine) that are shed by diseased tissues during the onset and development of a wide variety of diseases, including cancers, infectious diseases, autoimmune diseases, and traumatic injuries. PCMAT can also identify proteins in body fluids that can be used to monitor the success or failure of therapeutic regimens. Because of their low relative abundance in body fluids, these biomarkers are often missed by all other discovery strategies that are currently in use. PCMAT is significantly more sensitive, considerably faster and more cost-effective than competing genomic and proteomic technologies. PCMAT biomarkers are discovered in biological specimens obtained with little or no invasiveness.Market Opportunity: Biomarkers Market Expects Significant GrowthSize of MarketThe global biomarkers market achieved revenues of ~$6.3B in 2008 and is expected to hit ~$22.2B by 2015. In 2007, Agendia’s MammaPrint breast cancer diagnostic set the regulatory pathway by being the first of its kind to clear 510(k) submission – two additional in vitro diagnostics (IVD) products have since cleared. Opportunity Early diagnosis of disease is the best route to successful, cost-effective treatment. Current methods for identifying disease biomarkers are slow, costly and lack sensitivity. Our SolutionThe general PCMAT method for capturing and identifying biomarkers in body fluids:1. High abundance normal proteins are depleted from the serum, urine or saliva of diseased subjects using proprietary methods. 2. The remaining proteins, now enriched for biomarkers of interest, are used to immunize an appropriate host using powerful adjuvants. 3. The antibodies recovered after immunization are adsorbed with biological fluids from healthy subjects. This step results in the selective enrichment of antibodies reactive with disease-related biomarkers. 4. Resulting “bait” antibodies are immobilized onto a solid support matrix, and used to selectively capture biomarkers directly from biological fluids of diseased subjects. 5. Specifically captured proteins are eluted, and identified using conventional proteomics tools and bioinformatic analysis. Regulatory StatusAll PCMAT projects are in the discovery or initial validation phase• Next step on validated biomarkers – develop in appropriate diagnostic kit format. • Clinical device will require preclinical testing before application to the FDA with a 510(k) submission. • Success translates to large-scale clinical testing of new PCMAT-derived diagnostic tools. Proof-of-Principle• Successful in finding novel biomarkers for the serologic diagnostic of colorectal cancer.• Success in diagnosing infection of Valencia oranges by Liberibacter asiaticus, the etiological agent of Citrus Greening Disease. |
