Commercial Readiness for SAMBA HIV Whole Blood Semi Quantitative Test for Resource Limited Settings

Diagnostics for the Real World Ltd Commercialization Readiness Pilot Application SAMBA HIV Whole 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 HIV Semi Q Whole blood test viral load The Project Aims are related to tasks critical for successful commercialization and are related to the following areas assistance with manufacturing increasing manufacturing scale by instrument and cartridge design optimization process development for automated assembly and validation of the manufacturing process patent landscape analysis preparation of documentation for regulatory submission early implementation to show product impact and market research SAMBA technology will change HIV testing in Africa by addressing an unmet clinical need for HIV infection monitoring and therapy adherence and effectiveness it will allow nucleic acid amplification tests NAATs to be used for HIV viral load monitoring in remote resource limited settings and therefore positively impact HIV testing and treatment programs in Africa An earlier version of SAMBA SAMBA I is already making a positive impact by being used in small numbers in Africa by M decins Sans Fronti res MSF in Uganda and Malawi The SAMBA I and SAMBA II instruments are approved CE marked and DRW has just received CE mark for a SAMBA I HIV viral load test for plasma samples A second SAMBA I HIV test is expected to be CE marked within the next two months The SAMBA II instrument is an improvement over the SAMBA I instrument and the HIV Semi Q Whole blood test is an improvement over the SAMBA HIV Semi Q test for plasma SAMBA will support a social and commercial opportunity by fulfilling a critical unmet health care need DRW is focused on designing products for resource limited settings and therefore the drivers of its product design process necessarily address these issues This project fully aligns with the companyandapos s mission core values and its overall business plan It will aim to deliver a product test and instrument capable 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 World Ltd Commercialization Readiness Pilot Application SAMBA HIV Whole 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 test a blood testing tool that can help change HIV test and treat programs in Africa The project will focus on key aims including manufacturing scale up product verification and validation regulatory approval and market research It will allow HIV treatment monitoring at the point of care in remote rural resource poor settings close to where many people live and 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