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NEW YORK — Centogene said on Thursday that it has received Emergency Use Authorization from the US Food and Drug Administration for a PCR-based SARS-CoV-2 test.

According to Centogene, the test is designed to detect the virus in oropharyngeal swab specimens and may only be performed at the Rostock, Germany-based company's CLIA-certified lab.

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Antibody testing is expected to play an important role in the management of the COVID-19 pandemic. 


As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.