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

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Principal Investigator: HANJOON  RYU
Fiscal Year: 2021
Award: $24,361,759
Funding agency: National Heart Lung and Blood Institute

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.

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