Globe Newswire07.02.20
The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for Centogene N.V.’s SARS-CoV-2 RT-PCR test.
Centogene’s SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of SARS-CoV-2. It is intended to be used with samples of the upper respiratory tract collected from individuals suspected by their healthcare provider to have COVID-19, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient.
Prof. Arndt Rolfs, CEO of Centogene, said, “Over the past several months, we have been working tirelessly to ensure that we provide the best possible molecular diagnostic testing to prevent the further outbreak of COVID-19 and support the return to a new normal. This authorization by the FDA is another milestone for our COVID-19 testing efforts that validates the quality, precision and reliability of our tests.”
“Centogene is proud to have received this accelerated authorization from the FDA, which recognizes our continued commitment to the highest quality standards amid this global pandemic,” said Ellen Karges, SVP regulatory compliance & quality management. “Molecular testing is vital in diagnosing patients as early as possible, and we are confident that our test will support a successful fight against this novel outbreak especially in collaboration with our pharmaceutical partners, educational organizations and airports.”
Centogene’s SARS-CoV-2 RT-PCR test is a real-time test based on the reverse transcription polymerase chain reaction (RT-PCR) for the qualitative detection of SARS-CoV-2. It is intended to be used with samples of the upper respiratory tract collected from individuals suspected by their healthcare provider to have COVID-19, belonging to a risk cohort, or having been in contact with a confirmed COVID-19 patient.
Prof. Arndt Rolfs, CEO of Centogene, said, “Over the past several months, we have been working tirelessly to ensure that we provide the best possible molecular diagnostic testing to prevent the further outbreak of COVID-19 and support the return to a new normal. This authorization by the FDA is another milestone for our COVID-19 testing efforts that validates the quality, precision and reliability of our tests.”
“Centogene is proud to have received this accelerated authorization from the FDA, which recognizes our continued commitment to the highest quality standards amid this global pandemic,” said Ellen Karges, SVP regulatory compliance & quality management. “Molecular testing is vital in diagnosing patients as early as possible, and we are confident that our test will support a successful fight against this novel outbreak especially in collaboration with our pharmaceutical partners, educational organizations and airports.”
