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

由于缺乏大规模人群检测，缓解COVID-19带来的经济和健康挑战受到阻碍。现有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。它们缓慢、昂贵、难以制造，并且由于耗时的手动工作流程而使医疗保健专业人员超负荷;对高通量测试造成巨大障碍。 我们推出了一个新的诊断COVID-19的平台，其中包括一个数字测试，该测试将荧光侧流检测与我们正在申请专利的成本优化侧流测试平台相结合，该平台最初是为检测H1N1而开发的。 我们与主要合作伙伴建立了必要的联盟，以迅速扩大制造和分销的需求。鼻拭子（很快唾液样本）在15分钟内完成测试。数字结果以无线方式传送到参与者的移动的设备和云端，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功能。在第一阶段，该测试将部署到CLIA豁免的护理点诊所，步入式设施和免下车测试中心，数字测试不到35美元，每个一次性测试的有效成本不到10美元。 经过全面验证后，我们将利用机器视觉引导的自我测试，立即将部署扩展到家庭使用。通过将物联网技术与快速诊断测试相结合，我们相信我们具有独特的优势，可以将测试吞吐量提高10 - 100倍。RADx的重新实施将在高度压缩的时间框架内推动系统的推出，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.