GenEndeavor LLC — Department of Health and Human Services SBIR Phase I: NICHD

Description

Project Summary Objectives The long term objective of this application is to develop novel assays panels and kits to enable rapid and early point of care POC testing of TB in children The envisioned POC test would be administered in home by mothers to their children and in local healthcare centers by community healthcare workers who can diagnose and begin treatment of children with TB within minutes upon first presentation instead of hours or days The POC test will use an innovative biotechnology called Isothermal Chain Reaction ICR ICR is a disruptive and enabling assay technology platform that will offer a new class of reagents relevant to TB medical healthcare and biomedical research ICR does not require any enzymes primers nucleotides master mixes extension reactions cDNA intermediates or thermocycling These benefits overcome constraints of PCR based technologies by being resistant to enzyme inhibitors found in laboratory samples and clinical specimens having higher specificity for rare mutations and lowering reagent costs ICR is anticipated to enable routine TB detection in children in a more sensitive selective rapid and affordable manner without having to invest in costly instruments and labor intensive sample preparation procedures for testing in local community settings Specific Aims Development of ICR probes to TB target sequences We will design and develop ICR assays to rapidly and isothermally detect synthetic target sequences associated with TB in a mixed population of templates in less than minutes under isothermal conditions without enzymes primers nucleotides or master mixes Detection of TB in non sputum samples We will use ICR assays from Aim to detect TB in retrospective exhaled breath condensation saliva and urine samples Results will be benchmarked to mycobacterial growth indicator tube cultures to demonstrate the feasibility of ICR TB detection in non sputum samples Detection of paucibacillary forms of TB from pleural fluid samples We will use selected assays as in Aim to detect TB in retrospective pleural fluid samples Results will be benchmarked and compared to PCR to demonstrate the feasibility that ICR has enhanced selectivity to detect TB pathogens missed by PCR in the paucibacillary form of TB common in children and that ICR is more amenable to POC TB testing Impact Accomplishing the Specific Aims could significantly impact rapid and early detection of TB pathogens in children when therapeutic interventions are much more effective and enable routine POC testing to screen monitor treat and stop transmission of childhood TB in local community healthcare settings Project Narrative The relevance of this project is to demonstrate the feasibility of rapid and sensitive detection of TB using a novel isothermal amplification technology The methods assays and reagents used in this project relate to enabling routine early testing and screening of TB in children at home and in local community healthcare settings in a rapid cost effective and easy to use manner with isothermal conditions in less than minutes