Siemens Healthineers’ COVID-19 assay given approval for use in Europe

Editor's Note

European regulators have approved Siemens Healthineers’ molecular Fast Track Diagnostics SARS-CoV-2 Assay, which has 100% specificity and sensitivity.

The new assay uses real-time polymerase chain reaction (PCR) to detect ribonucleic acid (RNA) from this virus.

The company plans to ship more than 1.3 million tests per month worldwide as production capacity increases in May.

The assay can be run in laboratories at the same time as other testing panels from Siemens facilitating identification of a wide range of pathogens that cause acute respiratory infections.