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Innovation

Bio-Rad Laboratories has been granted Emergency Use Authorization from the US Food and Drug Administration for a digital PCR molecular diagnostic test for SARS-CoV-2, the virus that causes coronavirus disease COVID-19.

The 2019-nCoV CDC ddPCR Triplex Probe Assay is now authorized for use on the firm's QX200 and QXDx Droplet Digital PCR systems, that will enable accelerated screening of individuals.

The PCR technology behind this assay was developed at LLNL.

Technology Advancement

The plate-based digital PCR test can process 93 patient samples in a run without the need for calibration against standards required for traditional RT-qPCR. It is authorized to detect SARS-CoV-2 in nasopharyngeal, anterior nasal and mid-turbinate nasal swab specimens, nasopharyngeal wash or aspirate, and nasal aspirate specimens. The assay uses the primers and probes developed by the US Centers for Disease Control and Prevention, and is authorized for samples extracted with the ThermoFisher MagMAX Viral/Pathogen Nucleic Acid Isolation Kit or Qiagen QIAamp Viral Mini Kit.

Impact

Bio-Rad's ddPCR COVID-19 test has been evaluated in preliminary studies of patient samples in China, showing enhanced sensitivity relative to standard methods. The ability to perform high throughput sample analysis coupled with increased sensitivity will enable faster screening of individuals for COVID-19 and will be important as contact tracking becomes an important tool in the monitoring of this epidemic.
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https://www.genomeweb.com/pcr/bio-rad-laboratories-gets-fda-emergency-use-authorization-ddpcr-covid-19-assay.XtWpV1B7lBw
Bio-Rad and LLNL won an R&D 100 award for the initial design of this equipment.

Bio-Rad Laboratories Gets FDA Emergency Use Authorization for ddPCR COVID-19 Assay

Lawrence Livermore National Laboratory |
Bio-Rad (Hercules CA)
Publication Date
May 4, 2020
Agreement Type
License