The applicant, Leversense, has recently licensed the piezoelectric-excited millimeter-sized cantilever (PEMC) sensor technology from Drexel University. The PEMC sensors are relatively simple devices that measure concentration of protein biomarkers through antibody-antigen binding chemistry and have a demonstrated sensitivity that is 100,000 times higher than the current industry standard, enzyme-linked immunosorption assay (ELISA). PEMC's significant advantage is the use of label-free reagents and simple measurement format. Such a high sensitivity is often needed as low abundant protein markers have been identified for diagnosis. The scientific development of the PEMC sensor technology is well published, having investigated a number of antigens ranging from pathogens to protein molecules in simple and in complex fluid environments. However, for the technology to be commercialized two limiting technology steps need to be overcome, and is the basis for this application. These are reproducible sensor fabrication and a measurement format that is suitable in a point-of-care setting. Phase I objectives of this application is to convert the method developed at Drexel University into a practical instrument that is easy to use in a typical physician's office or in an analytical laboratory setting. In Phase II, the method will be automated with custom built electronics, and a measurement format suitable for 24 (96 wells) simultaneous biomarker measurements with built in redundancy and quantification tools. A single plate is expected to need no more than 5 mL of serum and deliver concentration measurement at sensitivity of 100 femtogram/ml. Design goal for time to results (TTR) is 10 minutes. A second generation optimized sensor head will be designed as part of Phase II using the design inputs developed in Phase I. The applicant, Leversense, will develop an inexpensive instrument that measures 100,000 times more sensitively disease markers in blood samples. Because of its anticipated ease of use and low cost it is expected to be readily available for a doctor's office. Being able to test blood readily and quickly for complex diseases such as cancer, will enable early intervention, improve health care and reduce cost of health care.
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