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FDA Grants EUAs to Lucira Health Molecular COVID/Flu Test; Azure Biotech, CorDx COVID Antigen Tests

NEW YORK – The US Food and Drug Administration this week granted Emergency Use Authorizations to Lucira Health's molecular COVID-19/flu test, and to at-home COVID-19 antigen tests from Azure Biotech and CorDx.

On Tuesday, the FDA granted EUA to Lucira Health's molecular COVID-19 and Flu Test for use at the point of care. According to the agency, the test is the first molecular COVID-19 test to receive FDA authorization following collaboration with the US National Institutes of Health's Independent Test Assessment program, which was created to speed up the regulatory review of over-the-counter COVID-19 tests.

Emeryville, California-based Lucira's RT-LAMP-based test is for single use and detects SARS-CoV-2 viral RNA, as well as influenza A and B viral RNA, while differentiating the different viruses. The test uses a nasal swab collected by a healthcare provider and is for use only by authorized laboratories.

Also, the FDA said Monday it had granted EUAs to Azure Biotech and CorDx for their at-home COVID-19 antigen tests.

Both Azure Bio's Fastep COVID-19 Antigen Home Test and CorDx's CorDx COVID-19 Ag Test are lateral flow assays that qualitatively detect the nucleocapsid protein antigen from SARS-CoV-2 through anterior nasal swab samples.

Houston-based Azure Bio's Fastep assay is authorized for use by people with symptoms of COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

San Diego-based CorDx's CorDx assay is authorized for use within the first week of symptom onset, also when tested at least twice over three days with at least 48 hours between tests. Both tests are approved for use in people without symptoms when tested at least three times over five days with at least 48 hours between tests, the FDA said in its authorization documents.