AWARD A CONTRACT FOR RADX TECH - QORVO TO SECURE AN EUA APPROVED POC ANTIGEN TEST SYSTEM AS WELL AS INCREASE AN INCREMENTAL DAILY CARTRIDGE PRODUCTION

Qorvo生物技术公司<s:2>€™（Qorvo）研究性体声波（BAW）传感器检测平台（Omnia TM）针对在护理点（POC）环境中使用的病毒抗原检测。该平台旨在产生与中心实验室性能相匹配的可靠定量结果，并提高对POC测试的信心。经过6年多的时间开发，Qorvo的技术差异化在于检测核心，其中Qorvo优化了用于液体生物传感的低成本高产量（每天数百万部手机）的BAW设备。SARS-CoV-2抗原的检测伴随着生物传感器共振频率的变化，因为抗原（核衣壳和穗S1）蛋白团在传感器表面的特定探针上积累。传统的光学/荧光传感被高灵敏度、高特异性的固态质量传感所取代。虽然该提案的重点是抗原检测开发，但Qorvo已在同一BAW平台上提交了SARS-CoV-2 IgG抗体检测EUA，该EUA在不到10周的时间内完成，具有100%特异性和100%阴性交叉反应性的世界级性能。考虑到这只是之前通过该平台运行的十几项其他检测中的一项，结果使我们对执行病毒抗原技术和时间表任务的能力充满信心。Qorvo已经在抗体测试的制造基础设施商业开发以及现有的兽医和人类开发产品方面投入了大量资金，因此抗原将成为产品套件的一部分。RADx的帮助将加速监管和美国的大批量生产。

Qorvo Biotechnologies’ (Qorvo) investigational Bulk Acoustic Wave (BAW) sensor detection platform (Omnia TM ) targets viral antigen testing for use in Point-of-Care (POC) settings. The platform is designed to produce reliable and quantitative results matching central lab performance and improving confidence in POC tests.     Developed over a 6+ year timeframe, the technological differentiation is in the detection core, where Qorvo has optimized the BAW device that is made at low cost and high volume (millions per day for cell phones) for liquid biosensing. Detection of SARS-CoV-2 antigen occurs with a shift in the biosensor resonance frequency as antigen (Nucleocapsid and Spike S1) protein mass accumulates at specific probes on the sensor surface. Traditional optical/ fluorescence sensing is replaced by high-sensitivity, high-specificity solid-state mass-based sensing.   While this proposal is focused on antigen test development, Qorvo has submitted for a SARS-CoV-2 IgG antibody test EUA on the same BAW platform that was completed in less than 10 weeks with world-class performance of 100% specificity and 100% negative cross reactivity. Given this is just one of over a dozen other assays previously run through this platform, the results give us extreme confidence in our ability to execute the viral antigen technical and timeline tasks.    Qorvo has invested heavily in manufacturing infrastructure commercial development for the antibody test as well as existing veterinary and human development products so the antigen will be part of a product suite. RADx assistance will enable acceleration of regulatory and US-based high-volume manufacturing ramp.