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Helix, CoWin Biotech Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Helix OpCo and CoWin Biotech.

The Helix COVID-19 Test is designed to detect the SARS-CoV-2 nucleocapsid, ORF1ab, and spike protein genes in upper respiratory specimens. RNA extraction is performed using Thermo Fisher Scientific's MagMax Viral/Pathogen II Nucleic Acid Isolation Kit and the test runs on Thermo Fisher's QuantStudio 7 Flex Quantitative RT-PCR instrument.

The test may be performed only by San Mateo, California-based Helix, according to the FDA.

CoWin's Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit is designed to detect the virus' nucleocapsid and ORF1ab genes in oropharyngeal swabs. It runs on Thermo Fisher's Applied Biosystems 7500 RT-PCR system, according to the company, which is headquartered in Beijing and has a US office in Cambridge, Massachusetts.

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

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