D-3-hydroxybutyrate (HB) is a primary metabolite in diabetic ketoacidosis, alcoholism, and starvation. The untreated ketoacidosis can result in coma or death. The current tests for ketosis measure only acetoacetate, which is a minor ketoacid and is unstable, leading sometimes to errors in diagnosis. A simple, quick strip test for HB measurement will be a valuable tool for both diagnosis and management of ketosis.GDS Technology, Inc., has recently developed a thermostable D-3-hydroxybutyrate dehydrogenase (HBD) that will form the basis for a strip test (similar to Miles' or Boehringer's glucose test) for the determination of HB. Phase I feasibility research will focus on the development of a stable strip test by incorporating HBD enzyme and an indicator system that will produce color proportionate to the concentration of HB. The goal of Phase II will be to complete the development of the whole blood test and perform clinical studies. The program offers, for the first time, an opportunity for providing a simple and accurate test for ketosis or ketoacidosis that can be done on site, such as in a physician's office, emergency room, or at home during insulin therapy.
Anticipated Results:The commercial product is projected as a simple, easy-to-use test that can be performed on site for monitoring ketosis resulting from uncontrolled diabetes mellitus, alcoholism, starvation, or other diseases. The test will use a drop of whole blood from a fingertip and will yield results within 1 minute at a cost of 250 to 500 per test.National Institute Of Diabetes And Digestive And Kidney Diseases (NIDDK)
