Medical technology company Siemens Healthineers has introduced a molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay test kit.
The new assay helps in the diagnosis of infection caused by novel coronavirus SARS-CoV-2, which is responsible for the COVID-19 disease.
The Fast Track Diagnostics, a Siemens Healthineers company, has developed the new test kit. In 2017, Siemens acquired the Luxembourg-based Fast Track Diagnostics.
Siemens is supplying the test kits within the European Union for research use only (RUO), and focusing on pursuing emergency use assessment and listing (EUAL) from the World Health Organization (WHO) for clinical application.
Siemen has also started negotiations with the FDA to launch the test under emergency use authorization
The company has also started negotiations with the US Food and Drug Administration (FDA) to launch the test under emergency use authorization (EUA).
Siemens has optimised the FTD SARS-CoV-2 Assay on the Biomerieux EasyMag Extraction System and the Applied Biosystems 7500 Real-time PCR Thermocycler.
The test applies the same workflow, including PCR profile, as other FTD respiratory disease kits from the company.
Siemens’ test can be conducted in laboratories simultaneously with FTD Respiratory Pathogens 21, the company’s molecular syndromic testing panel that detects 21 different upper respiratory pathogens causing acute respiratory infections.
The firm will focus on the distribution of the test in the US and Europe, after regulatory approval.
Siemens Healthineers molecular diagnostics head Sebastian Kronmueller said: “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.
“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.”
In October 2019, Siemens Healthineers completed the acquisition of Corindus Vascular Robotics for around $1.1bn. Siemens included Corindus in the advanced therapies reporting segment.
