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Development of a Clinical Screening Platform for Type 1 Diabetes

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42DK115296-02
Agency Tracking Number: R42DK115296
Amount: $1,155,286.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDDK
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-20
Award End Date (Contract End Date): 2020-08-31
Small Business Information
Denver, CO 80206-3961
United States
DUNS: 016344134
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (303) 929-7865
Business Contact
Phone: (303) 929-7865
Research Institution
AURORA, CO 80045-2571
United States

 Nonprofit College or University

AbstractA major shortfall in clinical care for diabetes is a rapid and accurate screen for progression to diseaseCurrent criteria involve HLA haplotypeand the presence of auto antibodiesAAGenome wide associated studiesGWASrevealed only immune associated genes including HLA as T D predictorsThe ability to differentiate from other diseases was very limitedPre typediabetesp T Dis now being identified with diagnostic criteria that includeHLAAA presencesibling or primary relative proband etcHoweverno reliabletime to onsetcriteria have been establishedFurthermorethe current screens are time consumingexpensive and have low accuracyPreviously T D and T D were distinguished by age of onset and body mass indexBMIwith obesity related to T DHoweverwith obesity reaching epidemic proportions in the US and other western countriesBMI is no longer a distinguishing factorIn additionT D onset is occurring much later in lifereportedly as late asyears of agethus age of onset is no longer a reliable distinguishing factorThe American Diabetes Association and several European studies state that misdiagnosis of T D for T D or T D for T D occurs at leastof the timeOp TMune IncDenver CO is developing a rapid and accurate measure for autoimmune potential based on levels of CDexpressing T cells in human peripheral bloodUsing this screenwe differentiate p T D subjects aslowmoderateandhighriskunlike any other screening measureIn additionthe blood test distinguishes T D from T D very accuratelythus far in our screening systemIn Phasewe are proposing to establish a new staining protocol for auto aggressive T cells using small peptides as staining entitiesThis is the first time that has been attemptedIn Phasestudies we will complete development of a screening modulecomparing it to existing screens for diabetestesting its efficiency to predict complications in diabetesand furthering the T DT D discrimination abilityThis module will be directly marketed to clinical lab test companiesLabCorpQuest etcWe further will explore the possibility of using our test as a measure for therapeutic efficacy of immune modulatory drugsthereby constituting another marketing optionAkapplication for all entities will be filedIntellectual property on the test kit and optical reading device are filed or in progress This project is to design and market much more rapidmore accurate screen for autoimmune diabetestypeIn addition this platform will greatly improve risk assessment of pre diabetic subjects and substantially improve the ability to discern typeand typediabeteswhich currently has afailure rateIn additionwe are designing a point of care device for use in hospitalsclinics and physician offices to improve diagnosis accuracy and speed

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