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

第3136章再申请 该产品概念已更新，以包括流感病毒靶标沿着SARS-CoV-2。 Rapid Acute Respiratory Panel检测试剂盒将是一种在已部署的自动Revogene仪器上实施的分子IVD检测试剂盒，该仪器目前有4种FDA批准的传染病检测试剂盒。预期用途是从疑似病毒感染的症状患者采集的鼻咽标本中检测甲型流感病毒、B流感病毒和SARS-CoV-2病毒。这将是一个用于区分流感与SARS-CoV-2患者的多重病毒组，这将在我们即将到来的2020-2021流感季节中具有很高的临床价值。我们计划在2020年10月前推出具有EUA状态的该检测试剂盒。 该检测试剂盒将使用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批准的检测试剂盒。工作流程是自动化的，其中用户将需要在加载到仪器上之前将样本添加到测定耗材中。Revogene平台包含运行检测试剂盒并报告阳性/阴性结果所需的软件。该测定的实践复杂性非常低，没有精密移液步骤，并且符合CLIA豁免状态。我们目前在该领域有一个仪器的安装基地，在那里将进行这种测定。对于该产品概念，我们需要您的协助，以便与FDA讨论该概念，从而使我们能够获得EUA和CLIA豁免状态，特别是针对检测板中的Flu A/B靶标。

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.