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Co-Diagnostics Gets FDA Emergency Use Authorization for Coronavirus Test

NEW YORK — Co-Diagnostics said on Monday that its Logix Smart Coronavirus COVID-19 Test has received Emergency Use Authorization (EUA) from the US Food and Drug Administration.

According to Salt Lake City, Utah-based Co-Diagnostics, the PCR-based, single-well test uses the company's CoPrimer technology to detect the RdRp gene of the SARS-CoV-2 virus. It received CE-IVD marking in February.

Under the EUA, the test is now available for sale to CLIA labs in the US from the company's ISO-13485:2016-certified facility. It had previously been available on a limited basis under the FDA's emergency use policy to address the SARS-CoV-2 pandemic.