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.
Public Health Relevance Statement: 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. Terms: Adult; 21+ years old; Adult Human; adulthood; Affect; Algorithms; General Anesthesia; Antibodies; Biological Assay; Assay; Bioassay; Biologic Assays; Biopsy; Buffers; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Ulcerative Colitis; Ulcerated Colitis; Colonoscopy; Crohn's disease; Crohn disease; Crohn's; Crohn's disorder; Granulomatous Enteritis; eleocolitis; regional enteritis; Cross-Sectional Studies; Cross Sectional Analysis; Cross-Sectional Analyses; Cross-Sectional Survey; Disease Frequency Surveys; Diagnosis; Disease; Disorder; Endoscopy; endoscopic imaging; Feces; stool; Foundations; Future; Gastrointestinal Diseases; gastrointestinal disorder; Goals; Gold; Health; Histology; Therapeutic immunosuppression; Anti-Rejection Therapy; Antirejection Therapy; Immunosuppressive Therapy; artificial immunosuppression; immunosuppression therapy; Inflammation; Inflammatory Bowel Diseases; Inflammatory Bowel Disorder; inflammatory disease of the intestine; inflammatory disorder of the intestine; intestinal autoinflammation; Informed Consent; Small Intestines; small bowel; Laboratories; Longitudinal Studies; long-term study; longitudinal outcome studies; longterm study; Morbidity - disease rate; Morbidity; Noise; Pathology; Patients; Production; Complement Factor P; factor P; Properdin; Proteins; diagnostic kit; test kit; Diagnostic Reagent Kits; Reagent; Recombinant Proteins; Research; Investigators; Researchers; Research Personnel; Sales; medical college; school of medicine; medical schools; Sensitivity and Specificity; serology assay; Serology test; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Specificity; Standardization; Testing; Tissues; Body Tissues; United States; Universities; Measures; large bowel Crohn's disease; Crohn's Colitis; granulomatous colitis; large intestine Crohn's disease; base; sensor; improved; Site; Clinical; Phase; Medical; prognostic; Blood Serum; Serum; Disease Progression; Relapsed Disease; Recurrent disease; Collaborations; Contracting Opportunities; Contracts; Diagnostic; Knowledge; Adopted; Complex; Source; System; Location; Diagnostic Device; Diagnostic Equipment; American; membrane structure; Membrane; Performance; rapid diagnosis; aptamer; cohort; novel; General Public; General Population; Devices; Reporting; Proteome; Sampling; case-controlled; case control; Proteomics; portability; Leukocyte L1 Antigen Complex; 27E10 Antigen; Calcium-Binding Myeloid Protein P8,14; Calgranulin; Calprotectin; L1 Antigen; Leukocyte L1 Protein; Migratory Inhibitory Factor-Related Protein MRP; Myelomonocytic Antigen L1; Causality; causation; disease causation; Etiology; reagent testing; Address; Detection; Clinical Data; Clinical Management; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Validation; Monitor; Development; developmental; point of care; cost; Outcome; manufacturing facility; cost effective; prospective; prototype; clinical remission; primary care setting; inflammatory marker; inflammation marker; Biological Markers; bio-markers; biologic marker; biomarker; disease diagnosis; accurate diagnosis; targeted biomarker; protein biomarkers; protein markers; healthcare community; health care community; Disease stratification; clinical development; care costs; stool sample; stool specimen; lateral flow assay; lateral flow test; in-vitro diagnostics; detection limit; point of care testing; diagnostic algorithm
