Process development, automation and scale-up for SAMBA point-of-care Nucleic Acid test.

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DRW is marketing a simple, robust point-of-care nucleic acid diagnostic platform, called SAMBA, which allows complex, high-performance tests to be carried out in remote, resource-limited settings in developing countries and primary care settings in developed countries. The first SAMBA tests are for HIV: one to measure HIV viral load for treatment monitoring and one to detect HIV in infants in order to initiate early treatment. Due to WHO recommendation and international aid funding for viral load monitoring and early infant diagnosis in sub-Saharan Africa, $470 million will be available between 2017-2019 for HIV diagnostic procurement. To meet this demand, DRW must automate its test cartridge manufacture to allow a production scale of 1.5 million tests/annum. DRW proposes and requests funding for developing critical, challenging production processes that are appropriate for high-speed assembly and 100% inspection, to produce SAMBA tests for the developed and developing world market. The proposed project will further progress positive outcomes of concepts developed with support from Innovate UK for Production Line Readiness.