Chromologic LLC

NGS Based Metagenomic Screening of Ocular Infections - Project Summary/abstract: the Project Objective Is to Develop an Organism-agnostic Deep Sequencing-based Diagnosis of Ocular Infectious Disease From Microliter-sized Biopsies in Less Than 24 Hours and for Less Than $1000. Current Diagnostic Approach Relies on Bacterial and Fungal Cultures That Are Time-consuming (~2-3 Days) and Often Leads to the Overuse of Broad-spectrum Antibiotics. in Phase I, We Successfully Developed and Validated the Eye-path™ System, Demonstrating an Integrated Scalable Metagenomics Alignment Research Tool (SMART) With an Automated Dna Extraction System for Sample Preparation. This System Achieved a Low Limit of Detection (104 Cells/ml) and a Turnaround Time of <3 Hours for Bacterial Infections. in Phase Ii, We Plan to Optimize the Adaptive Sequencing Software for the Smart Adapt Algorithm, Validate the System in a Multi-site Clinical Study (university of California, Los Angeles and University of Washington) in Patients With Corneal Ulcer and Suspected Endophthalmitis, Validate the System as a Clia Ready Test and Initiate a Pre-submission Meeting With the Fda to Determine the Appropriate Regulatory Strategy for Eye-path to Be Considered as a Clia Waived in Vitro-diagnostic Device. the Success Completion of This Project Could Significantly Impact Ocular Infection Diagnosis and Treatment Planning, With Broader Applications in Point-of-care Devices and Non-ophthalmic Diagnostics, Helping to Combat Antimicrobial Resistance.