Abstract: A major shortfall in clinical care for diabetes is a rapid and accurate screen for progression to disease. Current criteria involve HLA haplotype, and the presence of auto-antibodies (AA). Genome-wide associated studies (GWAS) revealed only immune associated genes including HLA as T1D predictors. The ability to differentiate from other diseases was very limited. Pre-type 1 diabetes (p-T1D) is now being identified with diagnostic criteria that include, HLA, AA presence, sibling or primary relative proband etc. However, no reliable ?time-to-onset? criteria have been established. Furthermore, the current screens are time consuming, expensive and have low accuracy. Previously T1D and T2D were distinguished by age of onset and body mass index (BMI) with obesity related to T2D. However, with obesity reaching epidemic proportions in the US and other western countries, BMI is no longer a distinguishing factor. In addition, T1D onset is occurring much later in life, reportedly as late as 68 years of age, thus age of onset is no longer a reliable distinguishing factor. The American Diabetes Association and several European studies state that misdiagnosis of T1D for T2D or T2D for T1D occurs at least 33% of the time. Op-TMune Inc., Denver CO is developing a rapid and accurate measure for autoimmune potential based on levels of CD40 expressing T cells in human peripheral blood. Using this screen, we differentiate p-T1D subjects as ?low?, ?moderate? and ?high? risk, unlike any other screening measure. In addition, the blood test distinguishes T1D from T2D very accurately (100% thus far in our screening system). In Phase 1 we are proposing to establish a new staining protocol for auto-aggressive T cells using small peptides as staining entities. This is the first time that has been attempted. In Phase 2 studies we will complete development of a screening module, comparing it to existing screens for diabetes, testing its efficiency to predict complications in diabetes, and furthering the T1D / T2D discrimination ability. This module will be directly marketed to clinical lab test companies, LabCorp, Quest etc. We further will explore the possibility of using our test as a measure for therapeutic efficacy of immune-modulatory drugs; thereby constituting another marketing option. A 510(k) application for all entities will be filed. Intellectual property on the test kit and optical reading device are filed or in progress.

R42DK115296

2017-08-01

2021-08-31