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

为了满足Accula SARS-CoV-2 Test大流行规模部署的需求，梅萨生物技术公司将通过快速扩建设施来扩大生产规模，每天生产60，000个测试。目前的生产产量约为2,000次测试/天。我们建议分两个阶段进行生产规模扩大，在资金到位后的四周内，通过增加生产线和扩大现有设施，将产量提高到每天6,000次测试，这些设施可以迅速到位。未来四个月的第二阶段产能扩张将通过增加一个新设施、额外的干燥室空间和额外的生产线来进一步提高产能，产量可达60，000次/天。Accula Dock手术工具目前的生产能力将支持每天生产50台Dock手术工具。在我们目前的工厂，船坞产量的适度增加将使产量增加到200个船坞/天，在未来4个月内再生产18，000个船坞。鉴于Dock制造过程使用标准电子设备制造方法，Dock的制造能力也可通过使用合同制造进一步增强。因此，拟定的工作重点是检测试剂卡生产规模扩大，这需要通过扩大梅萨生物技术公司的生产能力来实现专门的生产工艺。

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.