Screening for Type 1 Diabetes: A blood test based on the CD40 biomarker

Period of Performance: 09/01/2012 - 08/31/2013


Phase 1 SBIR

Recipient Firm

Op-t-mune, Inc.
Denver, CO 80206
Principal Investigator


DESCRIPTION (provided by applicant): The goal of this application is to develop a test kit to quickly and accurately diagnose type 1diabetes;differentiate it from type 2 diabetes and screen for "pre-diabetes". Current screening methods involve multiple blood tests, HLA haplotype and the presence of diabetes associated auto-antibodies. We have discovered a means to distinguish T1D from non-autoimmune controls and importantly from T2D based on analysis of a biomarker from a single blood test. Using the biomarker CD40 as a T cell marker we show that T1D have significantly (p <10-7) greater percentages of CD4CD40 cells than controls or T2D subjects. In previous work we showed that CD4CD40 cells are highly pathogenic and that controlling these cells prevents diabetes onset and complications. Differences in these T cell levels provide a fast and reliable (we have 100 percent accuracy) means to differentiate T1D and non- autoimmune controls as well as T2D. We also determined that subjects meeting ADA/NIH criteria for pre-diabetes have substantially increased percentage/numbers of CD4CD40 T cells, suggesting that this biomarker combination will screen for T1D risk. In Phase I studies we will create a low cost, accurate kit based on an antibody detection platform for T1D screening and discrimination of T1D and T2D. We will perform studies to minimize blood requirements. We are developing a novel cell staining platform that utilizes molecule specific binding peptides instead of antibodies. This staining platform will be much less expensive and more accurate than use of monoclonal antibodies. Phase II studies will be to complete the test kits for FDA approval, complete a detector device specific for this test kit and move the inventions to commercialization phases. PUBLIC HEALTH RELEVANCE: The goal of this application is to develop a novel means to quickly and accurately diagnose type 1diabetes and differentiate it from type 2 diabetes using a simple blood test. This platform also includes a novel means to screen treatment efficacy, by creating a new, highly sensitive, much more affordable cell staining platform.