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FDA Grants Emergency Use Authorizations for Zeesan Biotech, UCSD Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Friday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Zeesan Biotech and the University of California, San Diego (UCSD).

Zeesan's SARS-CoV-2 Test Kit is designed to detect the ORF1ab and N genes of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swab specimens, as well as nasopharyngeal washes, nasopharyngeal aspirates, nasal aspirates, and bronchoalveolar lavage specimens. The test was validated for use on Thermo Fisher Scientific's Applied Biosystems QuantStudio 3 RT-PCR instrument, according to the Xiamen, China-based company.

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

The UCSD RC SARS-CoV-2 Assay is designed to detect the virus' ORF1ab and E genes in pooled samples containing up to five individual upper respiratory swab specimens. It runs on Roche's Cobas 6800 and Cobas 8800 systems.

The test may only be performed by UCSD, according to the FDA.

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