RADX TECH XTRAVA, INC. - SPERA COVID-19 AG TESTRAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM: TECH PROJECT #5834 XTRAVA, INC.

由于缺乏大规模人口检测，缓解新冠肺炎的经济和健康挑战受到阻碍。可用的平台是为实验室使用而设计的，依赖于复杂的技术和阅读器。它们速度慢、成本高、难以制造，而且耗时的手动工作流程使医疗专业人员不堪重负；这给高通量测试带来了巨大的障碍。我们推出了一个新型的新冠肺炎诊断平台，其中包括一个数字测试，它将荧光横向流动分析与我们正在申请专利的成本优化的横向流动测试平台相结合，该平台最初是为检测H1N1而开发的。我们已经与关键合作伙伴建立了基本的联盟，以快速扩大制造和分销到需求点。鼻拭子(很快还会有唾液样本)在15分钟内完成检测。数字结果被无线传输到参与者--欧洲™移动设备和云，从而为医疗保健提供者提供测试状态，并与卫生当局共享实时分析和监测能力。在第一阶段，该测试将部署到CLIA豁免的看护点诊所、免下车设施和免下车测试中心，数字测试的费用不到35美元，每个一次性测试的有效成本不到10美元。*在完全验证后，我们将立即通过利用机器视觉引导的自我测试将部署扩展到家庭使用。通过将经验证可实现大规模生产的物联网技术与快速诊断测试相结合，我们相信我们处于独特的地位，可以将测试吞吐量提高10倍-100倍。RADx的重新执行将推动该系统在高度浓缩的时间框架内推出，以满足巨大的需求。

Mitigating the economic and health challenges of COVID-19 is hindered by the absence of mass population testing. Available platforms are designed for lab-use and rely on sophisticated technologies and readers. They are slow, expensive, hard to manufacture and overload healthcare professionals with time consuming manual workflows; presenting massive obstacles to high throughput testing.  We introduce a novel platform to diagnose COVID-19, which includes a digital test that combines fluorescent lateral flow assays with our patent-pending cost-optimized lateral flow test platform which was initially developed to detect H1N1.  We have formed the essential alliances with key partners to rapidly scale up manufacturing and distribution to the points-of-need. Nasal swabs (and soon saliva samples) are tested in under 15 minutes. The digital results are wirelessly communicated to the participants’ mobile devices and the cloud thereby providing healthcare providers with test status and sharing real-time analytics and monitoring capabilities with health authorities. In the first stage, the test will be deployed into CLIA-waived point-of-care clinics, walk-in facilities and drive-thru testing centers for less than $35 for the digital test and with an effective cost of less than $10 per disposable test.   After full validation, we will immediately extend deployment to at-home use by leveraging machine vision-guided self-testing. By combining IoT technologies that are proven to enable large-scale production with rapid diagnostic testing we believe we are uniquely positioned to increase testing throughput by 10X-100X. RADx re-enforcement will propel the launch of the system in highly condensed timeframes to meet the enormous need.