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FDA Grants EUA for UCSF, Broad Institute, BioSewoom Coronavirus Tests

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a CRISPR-based SARS-CoV-2 test developed by the University of California, San Francisco and Mammoth Biosciences, and two PCR-based tests from the Broad Institute and BioSewoom.

The SARS-CoV-2 RNA DETECTR Assay from UCSF and Mammoth uses primer sets and CRISPR guide RNAs specific for the detection of the SARS-CoV-2 N gene. It performs reverse transcription and isothermal amplification, followed by Cas-12-mediated cleavage of the amplified product to confirm detection of the virus.

The assay uses fluorescence measurements on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx instrument — with a total run time of 45 minutes — as a readout and may only be performed by UCSF, according to the FDA.

The Broad Institute's CRSP SARS-CoV-2 Real-time Reverse Transcriptase-PCR Diagnostic Assay is designed to detect two regions in the SARS-CoV-2 N gene in upper respiratory and bronchoalveolar lavage specimens.

Nucleic acid extraction is performed with the Agilent Bravo Liquid Handling Platform and the test runs on either Thermo Fisher's Applied Biosystems QuantStudio 7 Flex Real-Time PCR system or its ViiA 7 Real-Time PCR System.

The test may only be performed at the Broad Institute's Clinical Research Sequencing Platform, the FDA said.

BioSewoom's Real-Q 2019-nCoV Detection Kit is designed to detect the SARS-CoV-2 RdRP and E genes  in nasopharyngeal swabs and aspirates, nasal mid-turbinate swabs, nasal swabs, oropharyngeal swabs, sputum, tracheal aspirates, and bronchoalveolar lavage specimens.

Nucleic acid extraction is performed with either Qiagen's QIAamp MinElute Virus Spin Kit or Roche's MagNA Pure 96 DNA and Viral NA Small Volume Kit, according to the Seoul-based company. The test runs on either Thermo Fisher's Applied Biosystems 7500 of 7500 Fast RT-PCR instruments, Thermo Fisher's Applied Biosystems QuantStudio 5 RT-PCR Instrument, or Bio-Rad's CFX96 or CFX96 DX RT-PCR Detection Systems.

BioSewoom's test may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

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