Development of an Optical Instrument For Label-Free Assays

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DESCRIPTION (provided by applicant): Healthcare costs in the US are rising at unprecedented rates. It is vital to foster new technologies that reduce the overall costs of disease diagnostics and research while simultaneously allowing for earlier detection and predictive medicine. Maven Technologies has developed an optical molecular-binding detection technique called Label-Free Internal Reflection Ellipsometry (LFIRE), a cost-effective, sensitive and high-throughput technology capable of displacing the more expensive ELISA for single- plex immunoassays and the Luminex platform for the multiplexed assay market. LFIRE reduces the workload for performing and developing assays, the costs of disposables, and the volumes of biological reagents needed. The team will use this knowledge to develop a commercial instrument based on LFIRE, named Polaron, capable of early diagnosis of complex diseases such as cancer, autoimmune, infectious and cardiovascular diseases, amongst others. The proposal describes four specific aims. First of all, two 'alpha' prototype units will be created. Second, five beta units will be installed at user sites for feedback and testing with a diagnostic kit manufacturers. Third will be assay co-development with our diagnostic partners, consisting of a validation study for the transfer of an ELISA kit to the LFIRE platform. The final aim is the launch of Polaron by May 2012. The project will benefit from collaboration with several sub-contractors and development partners with substantial resources and experience in the development of instruments, optical systems and disposable products in the life science, pharmaceutical and clinical diagnostic industries. During the course of the project, several highly skilled jobs will be created in software programming, optical engineering, surface science and assay development. PUBLIC HEALTH RELEVANCE: This project will bring to market an optical instrument capable of diagnosing complex diseases in minutes using minimally invasive strategies requiring just a drop of blood, saliva, or other bodily fluids. The same instrument will be used as a development platform for innovative medical diagnostic tests, which are more cost effective than any technology in the field and inherently more accurate for early disease detection. The instrument will be universal enough to target applications in three areas; clinical diagnostics, drug development, and life science research while also providing more sample information per minute than any instrument in its class.