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Novacyt, Co-Diagnostics, Other Test Firms Seek Fast-Track EUA Approval From FDA For Coronavirus Dx's

 
• By Sue Darcey

Diagnostics companies around the world – including Novacyt, Roche, Co-Diagnostics and Mammoth Biosciences – are developing and launching tests to fight the coronavirus in China and other countries as quickly as possible, and some are seeking Emergency Use Authorization (EUA) approval from the FDA so their assays can be used on US patients.

Coronavirus deadly outbreak and coronaviruses influenza background as dangerous flu strain cases as a pandemic medical health risk concept with disease cells as a 3D render.

At least three diagnostics firms with a worldwide presence – Co-Diagnostics Inc., Novacyt and Roche – say they’ve launched either research-use-only (RUO) or final diagnostics tests to detect coronavirus for use in China and the US, while a fourth firm, Mammoth Biosciences in San Francisco, is working on another.

At least two of the firms, Co-Diagnostics and Novacyt, are seeking Food and Drug Administration Emergency Use Authorization (EUA) approval for use of their tests in the US.

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