It is planned to develop two tests as improvements on and replacements for the currently used time-averaged glycohemoglobin test. The improvements deal with resolving the retrospective report into time segments to give more information regarding periods or episodes of hypoglycemia, hyperglycemia, and normal periods, all of which are now averaged into one batch hemolysate. The two tests differ in complexity and in their actual time resolution.The concept of time series analysis from a single sample is proprietary to Chronomed, Inc. The technology is applicable to markets well beyond diabetes, including diagnostics and monitoring devices in the fields of hematology, alcoholism, drug therapy compliance, and measurement of control in other metabolic diseases (e.g., galactosemia). Long-term objectives are to bring products to market using the time series analysis concept, both for diabetes and other fields. The specific goal of this Phase I project is to complete the design of feasibility models of both high- and low-resolution methods and to provide a preliminary demonstration of improved clinical test results with their use. Density gradient and fluorescence cytometry methods will be used. Simplification of procedures for actual clinical use is part of the task.
Anticipated Results:The potential market for time-resolved glycohemoglobin testing is 26 million tests per year in the United States and Canada. At $2 per test, the manufacturer's market potential is over $50 million. Currently, only 15 to 20 percent of this market potential is penetrated by relatively primitive time-averaged tests.National Institute Of Diabetes And Digestive And Kidney Diseases (NIDDK)
