Siemens Healthineers Releases Test Kit for Coronavirus COVID-19
Siemens Healthineers announced today the availability of its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus that causes the COVID-19 disease. Test kits are already being shipped within the European Union for research use only (RUO) to expedite availability while the company continues to pursue Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) for clinical use. In addition, Siemens Healthineers has begun discussions with the U.S. Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). Both applications are in progress. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity.
• Siemens Healthineers test kit will help detect SARS-CoV-2, the cause of COVID-19
• Company is pursuing Emergency Use approvals from WHO and FDA for clinical use