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Fact File: Coronavirus Medtech And Diagnostic Updates

 
• By Lucie Ellis-Taitt

As the COVID-19 pandemic escalates, companies across the world are preparing to roll out commercial test kits for the detection of SARS-CoV-2.

Test tube with blood sample for COVID-19 test, novel coronavirus 2019 found in Wuhan, China

In the US, the Food and Drug Administration has issued Emergency Use Authorizations (EUAs) to approve tests for the new coronavirus. This allows temporary use of novel devices in emergency public health emergency situations.

On 17 March, the agency announced a new guidance that will allow state laboratories to develop tests and the FDA...

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