The kits are being shipped within the EU for research use only (RUO) to expedite their availability.
The company is pursuing Emergency Use Assessment and Listing (EUAL) from the World Health Organization (WHO) and emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for clinical use of the kits.
The commercial launch of the assay is planned in the US and Europe after securing regulatory approval.
Siemens Healthineers Molecular Diagnostics head Sebastian Kronmueller said: “With this molecular diagnostic assay, we want to make a contribution to fighting the current Covid-19 global pandemic by delivering fast and accurate SARS-CoV-2 testing.
“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.”
Like other FTD Respiratory Disease kits from Siemens Healthineers, the FTD SARS-CoV-2 Assay has been optimised on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler. It uses the same workflow, including PCR profile.
The assay can be run in laboratories simultaneously with FTD Respiratory Pathogens 21.
Siemens Healthineers’ FTD Respiratory Pathogens 21 is a molecular syndromic testing panel that detects 21 different upper respiratory pathogens related to acute respiratory infections.
Acquired by Siemens Healthineers Company at the end of 2017, Fast Track Diagnostics has developed the FTD SARS-CoV-2 Assay.