Siemens Healthineers has launched its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit to detect COVID-19.

The tests have not yet received approval or emergency use authorizations from either the US FDA or the World Health Organization. According to the company, both applications (FDA and WHO) are in progress.

In the meantime the company has expanded its production capacity and began shipping the kits within the European Union for research use only, which would expedite availability once (if) authorized.

The FTD SARS-CoV-2 Assay, which was developed by Siemens’ subsidiary Fast Track Diagnostics (Luxembourg), has been optimized on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler and utilizes the same workflow, including PCR profile, as other FTD Respiratory Disease kits from Siemens Healthineers.

It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21, a molecular syndromic testing panel from Siemens Healthineers that identifies 21 different upper respiratory pathogens that can cause acute respiratory infections.

“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,” said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. “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 FTD SARS-CoV-2 Assay was developed by Fast Track Diagnostics, a Siemens Healthineers Company, in Esch-sur-Alzette, Luxembourg. Fast Track Diagnostics was acquired by Siemens Healthineers at the end of 2017.


Image: NIAID. Novel Coronavirus SARS-CoV-2. Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.