Rapid Quantitative Point-of-Care Cardiac Marker Test

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DESCRIPTION (provided by applicant): The development of a portable, rapid and quantitative point-of-care (POC) system for the evaluation of patients with potential acute coronary syndromes (ACS) is proposed. The system will be used to rapidly triage patients with chest pains by measuring multiple cardiac marker (CM) concentrations. The system will have use in emergency departments, doctors' offices and ambulances for the rapid identification of patients with ACS, and will reduce unnecessary hospital admissions, reduce hospital costs, and prevent the inadvertent release of patients with ACS. The system will improve on currently available POC CM tests by providing rapid and economical methods of quantifying multiple CMs using a portable instrument format. This will significantly improve the efficiency of CM testing, by allowing CM measurement in ambulances, doctors' offices and patients' homes, as well as convenient bedside testing in hospital emergency departments. The system comprises of two parts, a disposable electrochemical assay strip, and a hand-held device for reading and quantifying the assays. The key innovation in the proposed work is the application of rapid and convenient flow-through assay formats, combined with electrochemical biosensors that allow sensitive multi-analyte quantification. The specific aims of the Phase I are to fabricate proof-of-concept electrochemical immunoassays and demonstrate their use in simultaneously quantifying two important CMs in serum samples, myoglobin and troponin I, in serum samples. The Phase I program will demonstrate the feasibility of our system, providing proof-of-concept electrochemical assays which will be developed in Phase II into higher-density assay strips containing sensing electrodes for a wider range of CMs, together with the development of a prototype electrochemical assay reader. Rapid, portable, quantitative and economical POC tests for CMs will be valuable tools for diagnosing patients with ACS. CM POC testing is expected to grow more than 20% per year over the next several years, reaching sales of over $160 million in 2006. There is an excellent opportunity to create a niche for our technology, which has advantages over current POC tests. EIC has a clear commercial path for assay technology through in-house manufacturing, sale of electrochemical assays and hand-held assay readers, and out-licensing of our multianalyte immunoassay technology.