BIODE proposes to demonstrate the sensing element for an objective, homogenous assay for cardiac troponin I (Phase I) and other markers of acute myocardial infarction (Phase II). The sensor employs next- generation piezoelectric detection technology based on the surface transverse wave (STW) and antibody capture. Recent design, modeling and manufacturing advances will overcome prior difficulties with the STW, allowing a 100-fold sensitivity increase over the well-known quartz crystal microbalance (QCM). Improved attachment chemistries will improve the sensor's resistance to protein and cellular fouling. BIODE expects the Phase I project to demonstrate the suitability of the approach, demonstrating clinically relevant detection levels and high selectivity for cardiac troponin I. Phase II effort will address the medical requirements of the device and will include partnerships with medical doctors and other relevant personnel. The end result of the project will be a medical instrument requiring only buffer solutions and resulting in virtually no disposable wastes. The sensor will be reusable and require minimal operator training. It will be suitable for use by emergency medical service personnel since it will provide an objective result which can be communicated to emergency room physicians. By offering the earliest possible diagnostics, myocardial infarction mortality will be substantially reduced. PROPOSED COMMERCIAL APPLICATIONS: The proposed instrument will be applicable to emergency room, laboratory and ambulance based testing for the earliest detectable signs of myocardial infarction. Related instrumentation has relevance to food testing, bio- chemical counter-terror and related applications for the detection of bacterial toxins and other small macromolecules.
