Benzinga | Oct 19, 2020 06:31AM EDT

CENTOGENE Receives FDA Emergency Use Authorization for SARS-CoV-2 RT-PCR Assay for Individuals Without Symptoms or Other Reasons to Suspect COVID-19

Centogene N.V. (NASDAQ:CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for 'CentoSure', the company's latest SARS-CoV-2 RT-PCR test. The EUA permits the usage of this test for individuals without any symptoms or suspicion of COVID-19 -- supporting widespread testing for the global population.

Prof. Arndt Rolfs, CEO of CENTOGENE, said, "This emergency use authorization by the FDA is an extremely important further step to prevent a further spread of COVID-19, specifically in countries that have been heavily impacted, like the U.S. Our experiences to date show that infected people do not always develop symptoms or are unknowingly spreading the virus days before they start to feel sick. Broad preventative testing is the best way to detect SARS-CoV-2 infections and successfully preventing the next wave of infections to effectively fight the COVID-19 pandemic. We are proud to be able to support the global community by providing the best possible molecular diagnostic test available."

"We are excited to have been granted this emergency use authorization by the FDA -- further validating our commitment to quality, precision, and reliability amid this global fight against the novel coronavirus," added Dr. Florian Vogel, Senior Vice President Clinical Lab Operations of CENTOGENE.