Assay for Monitoring Glycemic Control in Diabetics
Department of Health and Human Services
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Small Business Information
BIOTEX, INC., 8058 EL RIO ST, HOUSTON, TX, 77054
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Diabetes is currently believed to afflict over 100 million people worldwide and nearly 18 million in the United States. In the U.S. this disorder, along with its associated complications, is ranked as the seventh leading cause of death. To significantly improve diabetes management, there is an urgent need for diagnostics to assess compliance to of diabetics to various treatment methods, and, in particular, to intensive insulin therapy (e.g. by insulin injection, pump use, or by the implementation of a closed loop system in the near future). BioTex researchers propose to develop an affordable diagnostic kit for retrospective assessment of glycemic control in diabetics over a preceding time frame of 1-6 weeks. BioTex' innovative assay will simultaneously targets several glycation products in serum, whose degree in non-enzymatic condensation reaction with glucose correlates with the mean glucose level in blood. Since the glycated protein targets will have different life times, the assay will provide the mean glucose level not only for one time frame, but 5 different time frames within the past 6 weeks. The innovative element of the the disposable diagnostic kit will be the use aptamers - short oligonucleotides - for specific binding to the protein targets, and quantum dots for fluorescence detection. To accomplish this task, in Phase I we will perform proof-of- concept by selecting aptamers specific to five glycated proteins (e.g. hemoglobin HbA1c, IgM, IgG, serum albumin, and fibrinogen), followed by fluorescence detection using a microplate reader. Aptamers will be selected from random libraries by SELEX protocol (Systematic Evolution of Ligands by Exponential enrichment) that will allow us to screen ligands to a selected number of prominent glycated proteins (in an automated and rational way within a few days only). In stark contrast to antibodies, aptamers are much more affordable to produce with much better reproducibility. BioTex researchers are confident that this novel approach, if successful, can significantly enhance the clinical relevance of retrospective monitoring of glycemic control, especially for assessing clinical effectiveness of a closed loop system. PUBLIC HEALTH RELEVANCE: There is an urgent need for diagnostics to assess compliance to various treatment methods of diabetes, and, in particular, intensive insulin therapy (e.g. by using insulin pumps, or an artificial beta cell in the near future). Diabetes is currently believed to afflict over 100 million people worldwide and nearly 18 million in the United States. In the U.S. this disorder, along with its associated complications, is ranked as the seventh leading cause of death. BioTex proposes to develop a innovative diagnostic kit for assessing compliance of diabetics, who undergo intensive insulin therapy. Compliance will be assessed by retrospective evaluation of glycemic control (mean glucose level) over the preceding 6-8 weeks (1-6 weeks) within different time windows. The clinical utility of this kit will allow the clinician to make more meaningful decisions about adjustments of insulin therapy, life-style, or diet.
* information listed above is at the time of submission.