Development of a Clinical Screening Platform for Type Diabetes

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 T D predictors The ability to differentiate from other diseases was very limited Pre type diabetes p T D 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 T D and T D were distinguished by age of onset and body mass index BMI with obesity related to T D However with obesity reaching epidemic proportions in the US and other western countries BMI is no longer a distinguishing factor In addition T D onset is occurring much later in life reportedly as late as 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 T D for T D or T D for T D occurs at least of the time Op T Mune Inc Denver CO is developing a rapid and accurate measure for autoimmune potential based on levels of CD expressing T cells in human peripheral blood Using this screen we differentiate p T D subjects as low moderate and high risk unlike any other screening measure In addition the blood test distinguishes T D from T D very accurately thus far in our screening system In Phase 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 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 T D T D 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 k application for all entities will be filed Intellectual property on the test kit and optical reading device are filed or in progress Project Narrative This project is to design and market much more rapid more accurate screen for autoimmune diabetes type In addition this platform will greatly improve risk assessment of pre diabetic subjects and substantially improve the ability to discern type and type diabetes which currently has a failure rate In addition we are designing a point of care device for use in hospitals clinics and physician offices to improve diagnosis accuracy and speed