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 BioTechnologies？™(Qorvo)研究体声波传感器检测平台(OMNIA TM)目标是用于护理点(POC)环境的病毒抗原检测。该平台旨在产生与中心实验室性能匹配的可靠和定量结果，并提高PoC测试的可信度。经过6年多的时间框架开发，技术差异在于检测核心，Qorvo优化了BAW设备，该设备以低成本和高容量(手机每天数百万)制造，用于液体生物传感。SARS-CoV-2抗原的检测是随着生物传感器共振频率的变化而发生的，因为抗原(核衣壳和Spike S1)蛋白质质量积累在传感器表面的特定探针上。传统的光学/荧光传感技术正在被高灵敏度、高特异性的固态质量传感技术所取代。虽然这项建议的重点是抗原测试开发，但Qorvo已经在同一个BAW平台上提交了SARS-CoV-2 IgG抗体测试EUA，该平台在不到10周的时间内完成了世界级的100%特异性和100%阴性交叉反应的性能。鉴于这只是之前通过该平台运行的十几种其他检测之一，结果让我们对我们执行病毒抗原技术和时间表任务的能力充满信心。诺基亚Qorvo已投入巨资制造抗体测试的基础设施商业开发以及现有的兽医和人类开发产品，因此该抗原将成为产品套件的一部分。RADx援助将加速监管和美国的大批量制造。

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.