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

重新提交3136号申请。这一产品概念已经更新，包括流感病毒靶点和SARS-CoV-2。快速急性呼吸小组检测将是一种分子免疫缺陷病毒检测，它将在已经部署的Revogene自动化仪器上进行实践，该仪器目前有4种传染病，FDA批准了检测。其预期用途将是从疑似病毒感染的有症状患者的鼻咽样本中检测甲型流感、乙型流感和SARS-CoV-2病毒。这将是一个用于区分流感和SARS-CoV-2患者的多重病毒小组，在即将到来的2020-2021年流感季节将具有很高的临床价值。我们计划在2020年10月推出EUA状态的这项检测。该检测将使用PCR扩增技术结合实时荧光检测来检测这些病毒靶标的RNA序列，类似于我们FDA批准的检测。工作流程是自动化的，用户需要在加载到仪器之前将样本添加到分析消耗品中。Revogene平台包含运行检测和报告阳性/阴性结果所需的软件。这种分析的复杂性非常低，不需要精确的移液步骤，符合CLIA豁免状态。我们目前有一个现场安装的仪器基地，将在那里进行这一测试。对于这一产品概念，我们将需要您的帮助，与FDA讨论这一概念，以使我们获得EUA和CLIA豁免地位，特别是在专家小组中针对流感A/B目标。

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.