Siemens Healthineers (ETR: SHL) announced today that it is making its Fast Track Diagnostics (FTD) test kit for COVID-19 available as it seeks FDA emergency use authorization (EUA) and other forms of regulatory approval.
The FTD SARS-CoV-2 assay kit is designed to diagnose infection by the SARS-CoV-2 virus that causes coronavirus. Siemens Healthineers is already shipping test kits within the European Union for research use only as it attempts to secure clearance in the U.S., too.
Siemens Healthineers said in a news release that it is in discussions with the FDA over an EUA application, while it is also pursuing emergency use assessment and listing (EUAL) from the World Health Organization (WHO) for clinical use. In preparation for potential authorization, the company is expanding its production capacity as well.
The assay was developed by Siemens Healthineers’ FTD in Luxembourg. It has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 real-time PCR thermocycler. It is designed to be run in laboratories simultaneously with FTD respiratory pathogens 21, a molecular syndromic testing panel for identifying upper respiratory pathogens that can cause acute respiratory infections.
If the assay garners regulatory approval, Siemens Healthineers intends to immediately begin a commercial roll-out in the U.S. and Europe.
“With this molecular diagnostic assay, we want to make a contribution to fight the current COVID-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing,” Siemens Healthineers head of molecular diagnostics Sebastian Kronmueller said in the news release. “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.”