RADX PROGRAM: TECH PROJECT NO 6114 FLUIDIGM ADVANTA DX SARS-COV-2 RT-PCR ASSAY FOR SALIVA

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Fluidigm's BioMark HD microfluidics platform addresses the massive demand for SARS-CoV-2 PCR testing- combining speed, minimal cost, and massive throughput unparalleled in the industry.  Further advantages include flexibility to rapidly integrate new mutational markers or increase panel size to include additional infectious agents.  This platform works with all clinical sample types.  1) Technology Development  Our solution leverages Advantaâ„¢ Dx SARS-CoV-2 RT-PCR Assay submitted for an EUA, and two assays under development that can change the landscape for detection.  This assay allows for up to 6000 samples per day on a single system.    Additional assays address different needs in testing, throughput, specificity and sensitivity.  Modifications to the current workflow increases throughput to 48,000 tests per day while maintaining the identity of each sample.   To distinguish between SARS-CoV-2 infection and other respiratory viruses, we will deploy our multiplexed capability to create a pan-respiratory panel.   Cost estimates are preliminary based on assumptions of volume and distribution model. To enable pre-symptomatic screening, we are working with the DARPA ECHO program on a host response signature that can be run on the same platform.    2) Scaleup  In three months our goal is to scale up manufacturing to over one million tests per day delivering 80 million tests by end of year.  Investments in incremental capacity will deliver a cumulative run rate of 4.5 million tests per day in mid 2021.  These two components provide a robust platform for scale up of testing for SARS-CoV-2 that allows for the simultaneous detection of other respiratory pathogens.