Described herein is the development of the """"""""EVEIA"""""""" immunoassay that has the potential to supplant existing techniques for the validation of low-abundance biomarkers. Protein assays are a core technology of modern medicine, as nearly all diseases (including cancer) can be detected by monitoring protein concentrations in the human body (e.g. PSA, BRAC-1&2). However, the validation of newly identified low-abundance biomarkers (a rapidly growing list due to the Human Genome Project) is an area that is not well-served by current technology. EVEIA will become the platform of choice for biomarker validation mainly by displaying the superior sensitivity necessary for meaningful measurements of low-abundance proteins, but also by providing simpler assay development and being easier to use than other """"""""high sensitivity"""""""" assay platforms. Success in the validation arena should also lead to opportunities in the diagnostics market. Low-abundance proteins are hard to measure, especially in clinically relevant contexts such as plasma or saliva. This difficulty leads to a non-productive cycle in the research and clinical arenas in regards to such proteins. Since it is difficult to determine the clinical relevance of a protein that is difficult to measure, there is little demand for instruments to measure such proteins in the clinical laboratories. Conversely, with little clinical demand, there is little pressure to determine the clinical relevance of these low-abundance proteins. Unfortunately, most new protein discoveries can be expected to be found in low abundance. An instrument or assay that would make the measurement of such proteins easier would speed research and enhance clinical medicine. This application describes the basic, ongoing development of EVEIA, including comparisons with existing high-sensitivity assays. Controlled Process Technologies (CPT) has assembled a team with over 80 person-years of laboratory and instrument development experience, with authorship of nearly one hundred peer-reviewed publications and more than 15 issued patents. This team has the expertise to bring the EVEIA assay to the point that its applications in both the research and clinical laboratory are readily apparent. As specifically applied to cancer health-care, the EVEIA technology has the potential to greatly expand the population of available biomarkers by allowing the validation and analysis of low-abundance proteins that can be used for the diagnosis, monitoring, and basic research of human cancer. CPT is developing a protein immunoassay and instrumentation that is expected to have a level of sensitivity two to three orders of magnitude better than existing commercial instruments, while maintaining ease-of-use and cost benefits. Such an instrument will allow the study and detection of protein biomarkers discovered by the Human Genome Project that are normally found in concentrations too low for easy detection by current technology. Biomarkers that might be otherwise ignored could therefore become generally available for medical diagnosis and research. ? ? ?
