Predict Health LLC. proposes to develop and commercialize rapid, quantitative Point Of Care (POC) lateralflow tests for novel stool biomarkers, for the diagnosis and monitoring of inflammatory Bowel Disease. Thegoal is for the Lateral Flow Tests system to deliver the performance of clinical grade laboratory analyzers in aPOC platform with cost and workflow that is routinely and widely used in primary care settings. Dr.Mohan's Lab(Subaward Investigator, University of Houston) has identified three stool protein biomarkers using well-characterized healthy control, ulcerative colitis and Crohn's disease patient's samples in an aptamer basedproteomic screen. Phase I will focus on the procurement and standardization of antibodies to be used in theLateral Flow Tests (LFT). Stool sample extraction will be optimized and prototype LFT will be manufactured.LFT signal detection will be rendered portable and quantitative by adopting a POC device with multispectralsensor in collaboration with ams, USA (www.ams.com). The prototype POC LFT device will be tested in a well-characterized cohort of healthy control, ulcerative colitis and Crohn's disease patient's stool samples todemonstrate its functionality. During Phase II the prototype LFT will be analytically validated for limit ofdetection, precision, linearity and measuring range. Pre-defined validation and performance criteria will beestablished in conformance with established laboratory and clinical standards. LFT reagents that passanalytical validation and performance criteria will be transferred to contract manufacturing facilities forproduction of commercial grade POC LFT stool assays. Clinical validation will be performed using stoolsamples from cross sectional and longitudinal IBD cohorts and compared to the current yardstick, fecalcalprotectin, and evaluated for sensitivity, specificity, and test accuracy, to establish clinically actionalblediagnostic algorithms. The analytical and clinical data will be submitted to FDA for 510 (K) for use as an in vitrodiagnostic device for diagnosing and monitoring IBD. The availability of quantitative POC LFT stool assays ofconsistent quality and performance addresses a significant current limitation to establishing the clinical utility ofnew biomarkers for IBD and implementing their use in medical practice.
Public Health Relevance Statement: Project narrative
The ultimate goal of the proposed research is the manufacture and sale of point of care stool assays by a US
company (The Predict Health, LLC). The cost effective, easy to use, rapid, quantitative and widespread
availability of high-quality stool biomarker testing kits to the healthcare community will allow their use in clinical
testing for the diagnosis and monitoring of inflammatory bowel disease (IBD). Application of accurate new
clinical tests in conjunction with clinical knowledge of the etiology IBD will lead to reduced morbidity and cost of
care associated with this complex disorder affecting large numbers of adults and children.
Project Terms: <21+ years old><0-11 years old>| <27E10 Antigen>
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