Rapid and Quantitative Point Of Care Stool Assays For The Diagnosis And Monitoring Of Inflammatory Bowel Disease

Project Summary Predict Health LLC. proposes to develop and commercialize rapid, quantitative Point Of Care (POC) lateral flow tests for novel stool biomarkers, for the diagnosis and monitoring of inflammatory Bowel Disease. The goal is for the Lateral Flow Tests system to deliver the performance of clinical grade laboratory analyzers in a POC 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 based proteomic screen. Phase I will focus on the procurement and standardization of antibodies to be used in the Lateral 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 multispectral sensor 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 to demonstrate its functionality. During Phase II the prototype LFT will be analytically validated for limit of detection, precision, linearity and measuring range. Pre-defined validation and performance criteria will be established in conformance with established laboratory and clinical standards. LFT reagents that pass analytical validation and performance criteria will be transferred to contract manufacturing facilities for production of commercial grade POC LFT stool assays. Clinical validation will be performed using stool samples from cross sectional and longitudinal IBD cohorts and compared to the current yardstick, fecal calprotectin, and evaluated for sensitivity, specificity, and test accuracy, to establish clinically actionalble diagnostic algorithms. The analytical and clinical data will be submitted to FDA for 510 (K) for use as an in vitro diagnostic device for diagnosing and monitoring IBD. The availability of quantitative POC LFT stool assays of consistent quality and performance addresses a significant current limitation to establishing the clinical utility of new biomarkers for IBD and implementing their use in medical practice.