BioScale is developing a novel diagnostic platform for rapid and multiplexed detection of infectious agents utilizing a sensitive detection system based on an array of MEMS sensors. Our long-term vision is to develop an end-to-end system comprising an instrument and disposable cartridge that is capable of rapid detection of multiple target pathogens falling within an infectious disease syndrome and including bioterror agents. This system will provide significant advantage over current test methods that take many hours to several days to give results and typically only test for single pathogens. BioScale's platform is in a unique position to enable syndrome-based diagnostics of infectious diseases in the clinic and thereby create a distributed infrastructure for monitoring bioterror events. Our overall aim is to test the feasibility of immunosensor-based direct detection of pathogen agents. Our method is accelerated by active means that direct captured analytes to sensor surfaces. The Phase I project will pursue the following objectives: 1. Develop an engineered capture surface on the sensor to reduce nonspecific binding and implement model binding assays. 2. Develop the sample processing protocols for capture and separation of model analytes in complex sample matrices. 3. Develop components and protocols that direct the analytes to the sensors and accelerate their binding to the sensor surface. 4. Test a prototype system and assay protocols by performing complete cell detection assays on simulated samples and generate binding dose-response curves. These data sets will be utilized to assess the feasibility of this concept. By accomplishing these Phase I aims, we will have demonstrated the feasibility of direct measurement of an un-amplified sample of bacterial pathogens (i.e. without culturing cells or PCR of nucleic acids) on our platform. It will pave the way for the development of commercial syndrome based diagnostic systems that also cover diagnoses of bioterror agents.
