mFluiDx, Inc. — Department of Health and Human Services SBIR Phase I: NIAID

Description

SIGNIFICANCEmFluiDx is developing tests for a target pathogen occurring frequently in primary care settings that is difficult to differentiate by observing symptoms aloneCulturing takes too much timeand serology has poor sensitivityPCR is significantly more accuratehoweverit is too costlytime consumingand complex for primary care clinics to adoptDifficult diagnosis often compels multiple patient visitsincreasing hospitalization risk due to delayed treatmentAs automated NAAT solutions remain too costlythere are currently no point of care nucleic acid amplification testsPOC NAATideal for primary care testing of mFluIDx s target pathogenSuccessful development of a POC NAAT can help prevent hospitalizationreduce misuse of antibioticsand improve patient quality of lifeall while saving time and medical resourcesINNOVATIONmFluiDx is developing vacuum microfluidic technologiesa new class of microfluidics that enables automatedhighly multiplexedquantitative NAAT atX lower cost than conventional qPCR setupsSADesign primer probe sets for rapid isothermal amplificationmFluiDx will develop primers and probes for detecting the target pathogen based on a rapid isothermal amplification chemistrySADesign a low costautomated microfluidic nucleic acid sample preparation module for vacuum microfluidicsNucleic acid extraction is a major bottle neck that hinders POC NAAT deploymentRobotic systems are very costlyConventional spin columns kits require extra manual labormFluiDx will develop a sample prep modulewhich enables one step sample preparationThis will be the first sample preparation module designed for vacuum microfluidicswith a focus on low cost and automationSADesign a vacuum microfluidic readout chipmFluiDx will design a vacuum microfluidic module downstream of the sample prep moduleThis vacuum microfluidic module serves as a location for multiplexed isothermal amplification and optical readoutSAProof of concept one step NAAT withX less setup cost than qPCRmFluiDx will demonstrate one step NAAT from spiked samples after integrating the sample prep module with the vacuum readout chip in SAand SASuccessful development of mFluiDx s platform will be the first proof of concept of a POC NAAT for mFluiDx s target pathogenspecifically designed to be automated and low cost enough for primary care settingsDown the roadthis platform can perform multiplexed NAAT for other viral bacterial infections as wellA Phase II proposal will focus on scalable manufacturing designcompleting an optical readerand clinical performance studiesResults will be used for a FDAKapplication Via the I CORPS product market research methodologymFluiDx has identified a target pathogen in urgent need of point of care nucleic acid amplification testingPOC NAATmFluiDx is developing a test to detect this target pathogen in primary care settingswith a focus on increasing automation and lowering costUpon successful commercializationmFluiDx s platform will enable mass adoption of POC NAAT into primary care settings in both developing and developed countriesIn the futurethis platform can be used to detect various other viral bacterial pathogensleading to significant improvements in healthcare efficiency