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

与 RADX TECH - QORVO 签订合同，确保获得 EUA 批准的 POC 抗原测试系统并增加每日增量的试剂盒产量

• 批准号: 10505991
• 负责人: HANJOON RYU
• 金额: $ 2436.18万
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-02 至 2022-04-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10505991
• 关键词: 2019-nCoV; Acceleration; Acoustics; Antigens; Biological Assay; Biosensing Techniques; Biosensor; Cellular Phone; Contracts; Detection; Development; Devices; Fluorescence; Frequencies; Human Development; Immunoglobulin G; Infrastructure; Investigation; Liquid substance; Nucleocapsid; Optics; Performance; Production; Proteins; RADx; RADx Tech; Ramp; Running; SARS-CoV-2 antigen; Secure; Specificity; Surface; System; TimeLine; Viral Antigens; antibody test; antigen test; base; cost; cross reactivity; design; detection platform; improved; point of care; point of care testing; product development; sensor; solid state

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.

Qorvo Biotechnologies ™（Qorvo）研究性体声波（BAW）传感器检测平台（Omnia TM）针对用于床旁（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相匹配的可靠定量结果，并提高POC测试的信心。 经过6年多的时间开发，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（每天数百万手机）制造，用于液体生物传感。SARS-CoV-2抗原的检测随着抗原（核衣壳和刺突S1）蛋白质质量在传感器表面上的特异性探针处积累而发生生物传感器共振频率的偏移。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，该平台在不到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种其他检测方法之一，结果使我们对执行病毒抗原技术和时间轴任务的能力充满信心。 Qorvo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援助将加速监管和美国大批量制造的发展。