INSILIXA, INC. — Department of Health and Human Services SBIR Phase II: 172

Description

DESCRIPTION provided by applicant Phase II project submitted by InSilixa Inc a Silicon Valley start up company proposes to leverage Phase I accomplishments by developing a complementary metal oxide semiconductor CMOS biochip platform for the diagnosis of infectious diseases This project addresses the growing global threat of antibiotic resistant bacteria whose emergence and dissemination now complicates antibiotic selection decisions negatively affects prognosis increases health care costs and fuels increasing levels of resistance To tackle this crisis InSilixa will develop a highly multiplex platform that can simultaneously rapidly and inexpensively detect an infectious agent in a clinical sample and identify the mutations that confer drug resistance Specifically the work proposed in this application will entail the design implementation and experimental validation of a nucleic acid amplification testing NAAT method that uses the proprietary HYDRA CMOS biochip detection platform Aim will develop a single chamber closed tube and highly multiplexed NAAT technology that quantifies in real time and in parallel andapos s of multiplex PCR reactions and identifies and characterizes the sequences of the generated amplicons by performing andapos s of high resolution melt curve analysis MCA experiments Aim will further develop the CMOS biochip detection platform HYDRA K And Aim will develop a comprehensive NAAT assay based on combining the above technologies for detecting antimicrobial resistance in M tuberculosis Though the initial clinical focus is tuberculosis the design development and manufacturing know how gained during the course of this project will enable all other applications and products for the HYDRA platform Included amongst these are attractive commercial opportunities including respiratory tract infections drug resistant hospital acquired infections outpatient urinary tract and pharyngeal infections and the identification quantificatin and drug susceptibility genotyping of HIV in the blood of HIV AIDS patients The successful completion of this Phase II project will result in a fully characterized working prototype of the InSilixa CMOS biochip platform that can simultaneously identify an infectious agent and the mutations that confer resistance to a large panel of antibiotics PUBLIC HEALTH RELEVANCE This SBIR Phase II proposal will develop a new testing method for the diagnosis of infectious diseases The technology is based on a novel platform developed by InSilixa Inc a Silicon Valley andquot start upandquot company The diagnostic assay resulting from this project will be an electronic andquot biochipandquot that can identify an infectious agent directly ina patientandapos s clinical sample and determine its antibiotic resistance pattern Such information will inform clinical decision making improve patient outcome reduce cost and preserve our precious antibiotic arsenal