Siemens Healthineers Seeks FDA, WHO Clinical-Use Approvals for Coronavirus Test
April 02 2020 - 8:09AM
Dow Jones News
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 kim.richters@wsj.com
(END) Dow Jones Newswires
April 02, 2020 08:54 ET (12:54 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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