April 3, 2020—Siemens Healthineers announced the availability of its molecular Fast Track Diagnostics SARS-CoV-2 Assay test kit used to aid in the diagnosis of infection by the SARS-CoV-2 virus. Test kits are being shipped within the European Union for research use only to expedite availability while the company continues to pursue emergency use assessment and listing from the World Health Organization for clinical use. In addition, the company is in discussions with the FDA for release of the test under emergency use authorization.
“The Siemens Healthineers assay is designed to help researchers positively identify the virus in less than three hours so that health care professionals can proceed as quickly as possible with the necessary next steps on their patients’ triage paths,” Sebastian Kronmueller, head of molecular diagnostics at Siemens, said in a press release.
The FTD SARS-CoV-2 Assay has been optimized on the BioMérieux 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. It can be run in laboratories simultaneously with FTD Respiratory Pathogens 21, a molecular syndromic testing panel from Siemens that identifies 21 different upper respiratory pathogens that can cause acute respiratory infections.
The FTD SARS-CoV-2 Assay was developed by Fast Track Diagnostics, a Siemens Healthineers company.