SEACOAST SCIENCE, INC. — Department of Health and Human Services SBIR Phase II: 106

Description

Project Summary The overall objective in the proposed project is to develop and test a prototype Cyanalyzer sensor designed for the rapid and accurate diagnosis of cyanide exposure The proposed device directly addresses a long term goal of the National Institute of Neurological Disorders and Stroke NIH Countermeasures Against Chemical Threats CounterACT program development of rapid diagnostic tests and assays to identify biological markers consistent with cyanide exposure and the level of exposure Phase I equivalent research demonstrated that the current laboratory based Cyanalyzer prototype meets or exceeds each requirement necessary for rapid and accurate on site cyanide diagnosis currently diagnostic accuracy based a standard animal model of cyanide exposure N samples rabbits each with one blank non exposed and cyanide exposed samples rapid analysis time s sensitivity the limit of detection M is well below the threshold of exposure M which was set based on the maximum reported blood cyanide concentrations of smokers small sample volume L selectivity precision andlt relative standard deviation and accuracy During this Direct to Phase II SBIR project Seacoast Science Inc SSI in collaboration with South Dakota State University SDSU the University of California Irvine UCI and the Midwest Research Institute MRI propose carrying the Cyanalyzer from a research stage comprehensive analytical tool to advanced prototype development animal trials and completion of sufficient production units for a follow on multisite clinical trial The following specific aims are proposed to accomplish this objective Design and production of an optimized prototype of the academic cyanide diagnostic sensor units Method validation laboratory testing animal testing rabbit UCI and mouse MRI and analytical confirmation of the optimized prototype and Incorporation of lessons learned from specific aim scale up and initial production of approximately Cyanalyzer units for future multi site Phase III clinical trials Throughout all tasks Seacoast Science and SDSU will work with a FDA consulting firm to insure that appropriate steps are met to meet regulatory requirements necessary for device sales Project Narrative Cyanide is a potent toxin with extensive industrial use potential terrorist use and is a significant danger to fire fighters and civilians due to its presence in smoke from residential and industrial fires Seacoast Science proposes the production and testing of a medical laboratory device to diagnose cyanide exposure where no diagnostic is currently available The research plan for this proposal is divided into three tasks design and production of an advanced prototype confirmation of the device performance based on accurate diagnoses in two animal species and production of multiple units for future clinical trials