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NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorization for SARS-CoV-2 tests developed by Laboratorio Clinico Toledo and Assure Tech.

The Laboratorio Clinico Toledo SARS-CoV-2 Assay is designed to detect the virus' nucleocapsid gene, as well as the SARS-like coronavirus E gene and RdRP, in upper respiratory and bronchoalveolar lavage specimens. It uses Roche's MagNA Pure 96 nucleic acid purification system and runs on the Roche Light Cycler 480 PCR instrument.

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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.