INNOVATIVE OPTICAL SYSTEM FOR HEMAGGLUTINATION ASSAYS

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DESCRIPTION (provided by applicant): We propose to eliminate the time-consuming manual plate readout for hemagglutination assays by developing an innovative 96-well plate and associated optical reader capable of accurately and rapidly determining hemagglutination (+/-) and associated titer values in a fully automated system. The need for improved analytical tools for vaccine development and production is evidenced by the robust, cross-agency initiative to improve influenza vaccine manufacturing: Influenza Vaccine Manufacturing Optimization Program, which is a collaborative effort between NIH, BARDA, FDA, and the CDC. One identified problematic step in influenza vaccine development is the hemagglutination (HA) and hemagglutination inhibition (HAI) assays used to characterize influenza viruses. Currently, HA/HAI assays are conducted in 96-well plates which are read "by eye". The user must evaluate each well and manually record a (+) for hemagglutination and a (-) for no hemagglutination. While many of the liquid handling steps of assay preparation can be automated, plate reading is exclusively manual since no commercially available plate readers can differentiate positive and negative hemagglutination. InDevR has an excellent track record in translating innovative concepts into impactful products. InDevR is a privately-held biotechnology company located in Boulder, Colorado that develops and commercializes breakthrough detection and quantification technologies for microbiological analysis. Founded in 2003 by 3 members of the Chemistry Department at the University of Colorado, the company today has 25 employees and has taken two products to market that are now being sold world-wide. InDevR conducts all research, development, and manufacturing activities in-house.