MESA TECH INTERNATIONAL, INC. — Department of Health and Human Services SBIR Phase II: NIAID

Description

DESCRIPTION provided by applicant Rapid and accurate identification of highly infectious and pathogenic disease is extremely important for the early forecast of outbreak risk and the effective deployment of medical and administrative countermeasures Unfortunately current diagnostics for use at the point of care POC are largely immunological assays that often lack adequate sensitivity specificity and multiplex capacity for an accurate early diagnosis Nucleic acid based diagnostic products developed or under development requires a relatively expensive dedicated instrument that is often prohibitive to small clinics and resource limited settings and unsuitable for pandemic high capacity demand We propose to develop an instrumentation free self contained low cost andlt $ unit disposable rapid andlt minute sample to answer nucleic acid POC diagnostic device MTIDx capable of detecting influenza A influenza B RSV and RNaseP internal control plex The final MTIDx product is designed to be a FDA approved CLIA waived Clinical Laboratory Improvement Amendments of nucleic acid NA based diagnostic device for analyzing human nasal swab samples MTIDx Multiple Target Identification Diagnostic will be a pocket sized device that is easy to operate with minimal user intervention and also has an option to be powered by a V battery for use in resource limited field settings It will be suitable for high volume manufacturing allowing rapid production of millions of units to meet surge capacity during an epidemic outbreak The diagnostic system is based on the integration of Mesa Techandapos s proprietary technologies of nucleic acid extraction rapid amplification lateral flow based LF based colorimetric detection components with simple fluid control and microheater solutions into one easily used low cost disposable device In Phase project we have successfully developed of integrated device through a rapid prototyping approach Work in this Phase II project will focus on the optimization of Phase I design to include more refined design for a low complexity CLIA waved product as well as cost effective and environment friendly reusable electronic circuit component concept that allows the wide and rapid adaption at POC We will further optimize the development of lyophilized reagents to confer ambient storage compatibility development of stable buffer reagents and capsulation methods design for manufacturing optimizations and conduct performance evaluation on clinical samples The primary Phase II deliverable is the design of MTIDx ready for manufacturing Design For Manufacturing that offers a sample to answer plex diagnostic test Flu A FluB RSV and RNase P control under minutes prior to the follow up manufacturing FDA and marking effort PUBLIC HEALTH RELEVANCE To better protect the public from potentially deadly pandemic epidemic influenza outbreaks we will develop an instrumentation free self contained easy to use low cost andlt $ unit disposable rapid andlt minute sample to answer nucleic acid based Plex POC diagnostic device MTIDx capable of detecting influenza A influenza B RSV and RNase P as an internal control The final MTIDx product is designed to be a FDA approved CLIA waived Clinical Laboratory Improvement Amendments of nucleic acid NA based diagnostic device for analyzing human nasal swab samples This cell phone sized device will be compatible with high volume manufacturing and also an option to be powered by a V battery for use in resource limited field settings