ChemTrak has demonstrated feasibility of its AccuMeter technology for the quantitative and non-instrumented measurement of total cholesterol using finger stick derived whole blood. The test was approved by FDA on March 2, 1993 for consumer home use. In phase I HDL cholesterol project, technology for the separation of HDL from other lipoproteins was developed and the feasibility of adapting the technology to the blood separation device of the AccuMeter cassette was demonstrated. Progress has been made in improving the sensitivity required for the detection of HDL which is about four fold less in quantity as compared to total cholesterol. All reagent formulations have also been developed. Cassette design and plastic parts specifications have been established. Pilot HDL AccuMeter cassettes production was initiated. In Phase II, we plan to finalize the product design, develop, and scale up manufacturing processes and QC procedures. The finalized product will be used for establishing product clinical performance parameters such as assay precision, accuracy, and stability, etc. Formal multi-site clinical trials and product submission to FDA will be completed. The commercialization of the AccuMeter HDL cholesterol product shall be valuable tool for the education, prevention and early detection of coronary heart disease.
