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While the COVID-19 pandemic has caused a sanitary crisis around the world, pharmaceutical companies are going full steam ahead to develop solutions for diagnosing, treating and eventually curing the disease. The FTD SARS-CoV-2 Assay test kit presented by Siemens Healthineers on 2 April 2020 uses the same workflow as the company’s other FTD Respiratory Disease kits. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21, a molecular syndromic testing panel that identifies 21 different upper respiratory pathogens.

“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.”

Luxembourg specialist in infectious disease detection kits

The test kit has been developed by Fast Track Diagnostics, a Siemens Healthineers Company located in Esch-sur-Alzette in the south of Luxembourg. Founded in 2007 as a spin-off of one of Luxembourg’s largest medical laboratories, Laboratoires Réunis, the company was acquired by Siemens Healthineers at the end of 2017.

Fast Track Diagnostics specialises in the design, development and manufacture of infectious disease detection kits that use syndromic multiplex real time PCR. FTD assays are validated on clinical samples and detect a comprehensive range of viruses, bacteria, fungi and parasites. They are in routine daily use in over 60 countries worldwide.

Pursuing emergency use approvals

The COVID-19 test kits are already being shipped within the European Union to be used for research only. The company is applying for Emergency Use Assessment and Listing from the World Health Organisation (WHO) for clinical use, as well as for Emergency Use Authorisation by the US Food and Drug Administration (FDA). At the same time, Siemens Healthineers is expanding its production capacity.

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