Commercial Readiness for SAMBA HIV-1 Whole Blood Semi-Quantitative Test for Resource Limited Settings

Period of Performance: 08/01/2017 - 07/31/2018

$908K

Phase SBIR

Recipient Firm

Diagnostics for the Real World, LTD
Sunnyvale, CA 94085
Principal Investigator

Abstract

Diagnostics for the Real World, Ltd. Commercialization Readiness Pilot Application SAMBA HIV-1 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-1 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: 1) assistance with manufacturing - increasing manufacturing scale by instrument and cartridge design optimization; process development for automated assembly; and validation of the manufacturing process; 2) patent landscape analysis; 3) preparation of documentation for regulatory submission; 4) early implementation to show product impact and 5) market research. SAMBA technology will change HIV testing in Africa by addressing an unmet clinical need for HIV-1 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 Médecins Sans Frontières (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-1 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-1 Semi-Q Whole blood test is an improvement over the SAMBA HIV-1 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 company'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.