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 1 will develop a single-chamber, closed-tube, and highly multiplexed NAAT technology that quantifies, in real- time and in parallel, 10's of multiplex PCR reactions and identifies and characterizes the sequences of the generated amplicons by performing 100's of high-resolution melt curve analysis (MCA) experiments.
Aim 2 will further develop the CMOS biochip detection platform (HYDRA-4K).
And Aim 3 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 'start-up' company. The diagnostic assay resulting from this project will be an electronic 'biochip' that can identify an infectious agent directly ina patient'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.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HG007626-02
Application #
8906658
Study Section
Special Emphasis Panel (ZRG1-IMST-S (12))
Program Officer
Smith, Michael
Project Start
2013-09-09
Project End
2017-03-31
Budget Start
2015-04-01
Budget End
2016-03-31
Support Year
2
Fiscal Year
2015
Total Cost
$810,812
Indirect Cost
Name
Insilixa, Inc.
Department
Type
DUNS #
078649664
City
Sunnyvale
State
CA
Country
United States
Zip Code
94089