Siemens Healthineers Seeks FDA, WHO Clinical-Use Approvals for Coronavirus Test

   By Kim Richters 
 

Siemens Healthineers AG said Thursday that it has released a test kit to diagnose infection with the new coronavirus and is seeking emergency-use approvals from authorities.

The German medical equipment maker said its molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit can diagnose infection in less than three hours.

It is applying for emergency approvals for clinical use with the U.S. Food and Drug Administration and the World Health Organization, it said.

The company said it was already supplying tests within the European Union for research use, to speed up availability and expand production capacity for the kit.

"The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with the necessary next steps on their patients' triage paths," the company's head of molecular diagnostics Sebastian Kronmueller said.

Write to Kim Richters at [e-mail]

(END) Dow Jones Newswires

April 02, 2020 08:54 ET (12:54 GMT)

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