FDA Issues Emergency Use Authorization for Centogene’s COVID-19 Assay

The FDA has issued an Emergency Use Authorization to Centogene for the company’s new SARS-CoV-2 polymerase chain reaction (PCR) test for detection of the COVID-19 coronavirus.

The reverse-transcription PCR assay uses upper respiratory tract samples from potential or confirmed COVID-19 patients.

The test is intended for use by qualified laboratory personnel in the company’s high-complexity laboratories in Germany.