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Home » Business, Policy & Funding » Business News » Helix, CoWin Biotech Coronavirus Tests Get FDA Emergency Use Authorization

Helix, CoWin Biotech Coronavirus Tests Get FDA Emergency Use Authorization

Jul 27, 2020
|
staff reporter

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.

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