DIAGNOSTICS FOR THE REAL WORLD LIMITED — Department of Health and Human Services SBIR Phase II: NIAID

Description

Diagnostics for the Real WorldLtdCommercialization Readiness Pilot Application SAMBA HIVWhole Blood Semi Quantitative Test for Resource Limited Settings Abstract DRW is requesting Technical Assistance and Late Stage Development funding for commercialization of the SAMBA II HIVSemi Q Whole blood testviral loadThe Project Aims are related to tasks critical for successful commercialization and are related to the following areasassistance with manufacturingincreasing manufacturing scale by instrument and cartridge design optimizationprocess development for automated assemblyand validation of the manufacturing processpatent landscape analysispreparation of documentation for regulatory submissionearly implementation to show product impact andmarket researchSAMBA technology will change HIV testing in Africa by addressing an unmet clinical need for HIVinfection monitoring and therapy adherence and effectivenessit will allow nucleic acid amplification testsNAATsto be used for HIV viral load monitoring in remoteresource limited settings and therefore positively impact HIV testing and treatment programs in AfricaAn earlier version of SAMBASAMBA Iis already making a positive impact by being used in small numbers in Africa by M decins Sans Fronti resMSFin Uganda and MalawiThe SAMBA I and SAMBA II instruments are approvedCE markedand DRW has just received CE mark for a SAMBA I HIVviral load test for plasma samplesA second SAMBA I HIV test is expected to be CE marked within the next two monthsThe SAMBA II instrument is an improvement over the SAMBA I instrument and the HIVSemi Q Whole blood test is an improvement over the SAMBA HIVSemi Q test for plasmaSAMBA will support a social and commercial opportunity by fulfilling a criticalunmet health care needDRW is focused on designing products for resource limited settings and therefore the drivers of its product design process necessarily address these issuesThis project fully aligns with the companyandapos s missioncore values and its overall business planIt will aim to deliver a producttest and instrumentcapable of being manufactured at scale that will be ready for commercialization and will have the potential for transforming the lives of many and impacting the economies of countries threatened by HIV Diagnostics for the Real WorldLtdCommercialization Readiness Pilot Application SAMBA HIVWhole Blood Semi Quantitative Test for Resource Limited Settings Project Narrative DRW is requesting funding from NIH SBIR to help commercialize its SAMBA system and whole blood viral load testa blood testing tool that can help change HIV test and treat programs in AfricaThe project will focus on key aims including manufacturing scale upproduct verification and validationregulatory approvaland market researchIt will allow HIVtreatment monitoring at the point of carein remoteruralresource poor settingsclose to where many people liveand will help organizations working in Africa to expand their HIV treatment programs into the wider community and help to reduce the immense burden of HIV