RAPID ACCELERATION OF DIAGNOSTICS (RADX) TECH PROJECT #6139: REVOGENE SARS-COV-2 ASSAY

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Resubmission of Application 3136.   This product concept has been updated to include Flu viral targets along with SARS-CoV-2.  The Rapid Acute Respiratory Panel assay will be a molecular IVD assay practiced on an already deployed automated Revogene instrument which currently has 4 infectious disease FDA cleared assays. The intended use will be to detect the Flu A, Flu B and SARS-CoV-2 viruses from nasopharyngeal specimens collected from symptomatic patients suspected of viral infection. This will be a multiplexed viral panel for the differentiation of Flu from SARS-CoV-2 patients which will be of high clinical value in our upcoming Flu season 2020-2021. We plan to launch this assay with EUA status by October 2020.  The assay will detect RNA sequences for these viral targets using PCR amplification technology coupled with real-time flourescence detection similar to our FDA cleared assays. The workflow is automated where the user will need to add the specimen to the assay consumable prior to loading on the instrument. The Revogene platform contains the necessary software to run the assay and report out positive/negative results. This assay is of very low complexity to practice with no precision pipetting steps and is eligible for CLIA waiver status. We currently have an installment base of instruments in the field where this assay will be practiced. For this product concept, we will need your assistance in discussing this concept with the FDA to allow us to gain EUA and CLIA waiver status especially for the Flu A/B targets in the panel.