Siemens Healthineers Announces Availability of Molecular Fast Track Diagnostics SARS-CoV-2 Assay Test Kit

The 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 its clinical use. In addition, Siemens Healthineers has begun discussions with the US Food and Drug Administration (FDA) for release of the test under Emergency Use Authorization (EUA). After regulatory approval, the commercial roll-out of the assay is intended in the US and Europe. While the controlled roll-out of the assay for research use is continuing, Siemens Healthineers is simultaneously expanding its production capacity.

The FTD SARS-CoV-2 Assay has been developed by Fast Track Diagnostics, a Siemens Healthineers company. It 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 which 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.”

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