RAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM: TECH PROJECT #2244: EASY TO USE, LOW-COST MOLECULAR-BASED SARS-COV-2 TEST, HIGHLY SCALABLE

To address the need for pandemic-scale deployment of the  Accula SARS-CoV-2 Test, Mesa Biotech will scale-up manufacturing by rapid facility expansion to produce 60,000 tests per day. Current manufacturing output is approximately 2,000 tests/day. We propose a two phase manufacturing scale-up to increase output, over the four weeks following the availability of funds, to 6,000 tests/day through the addition of production lines and expansion of the existing facility that can be rapidly put in place. A second phase expansion of manufacturing capacity over the next four months will further increase capacity through addition of a new facility, additional dry room space and additional production lines to an output of up to 60,000 tests/day. Accula Dock instrument manufacturing capacity currently in place will support the production of 50 Dock instruments per day. Modest increases in Dock production at our current facility will increase this output to 200 Docks/day, producing additional 18,000 docks in the coming 4 months. Given that the Dock manufacturing process makes use of standard electronic device manufacturing methods, Dock manufacturing capacity may also be further augmented through the use of contract manufacturing. Therefore, the proposed effort focuses on test cassette production scale-up which requires specialized manufacturing processes best achieved by expansion of manufacturing capacity at Mesa Biotech.