Highly sensitive measurement of cTnI without a reader: the Xip solution

Project Summary Acute myocardial infarction (MI) is the biggest killer in the western world and is the cause of death for nearly 500,000 Americans each year. The symptoms of MI can be vague and non- specific and 7 million adults present to hospital Emergency Departments in the US each year with suspected MI. Advances in cardiac biomarkers have had a large impact on the diagnosis, risk stratification and management of suspected MI patients and rapid and sensitive testing of cardiac biomarkers, specifically troponin, has become the cornerstone for diagnostic workup and care of suspected MI patients. Rapid troponin testing can decrease time to appropriate treatment for MI patients and allow for faster MI rule-out, which will help decrease the billions expended annually for the care of non-MI patients in coronary care units. Yet, despite the clear need for sensitive and rapid cardiac troponin measurements to quickly diagnose and manage patients, there is no POC system that can match the analytical performance of contemporary sensitive laboratory systems. This project is intended to develop and commercialize a fully integrated POC immunoassay platform, based on a CMOS microchip, that is as easy to use as an over the counter pregnancy test and as accurate as high sensitivity laboratory tests. In addition to troponin, which is critically important, the system will be able to measure a myriad of other biomarkers for heart failure, pulmonary embolism and deep vein thrombosis, sepsis and other conditions where speed, convenience and in the field measurement of biomarkers is important.Project Narrative The lack of laboratory quality point-of-care (POC) tests forces providers to make decisions based on incomplete information. This effects outcomes and leads to massive unnecessary or even counterproductive spending. This project demonstrates a microchip-based assay platform that performs assays with laboratory performance, a one-step protocol, and which can be mass- produced using existing microchip production technology.