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NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests from by KogeneBiotech, Trax Management, and Compass Laboratory Services.

KogeneBiotech's PowerChek 2019-nCoV Real-time PCR Kit is designed to detect the SARS-CoV-2 RdRP and E genes in anterior/mid-turbinate nasal swabs, nasopharyngeal/oropharyngeal swabs, nasopharyngeal washes/aspirates or nasal aspirates, bronchoalveolar lavage, and sputum.

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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.