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FDA Reissues Color Coronavirus Test EUA for Sample Collection Changes

NEW YORK — The US Food and Drug Administration on Monday reissued an Emergency Use Authorization for Color's loop-mediated isothermal amplification-based SARS-CoV-2 test to reflect changes in the use of self-collected samples.

In May, the Color SARS-CoV-2 LAMP Diagnostic Assay received EUA for the detection of the SARS-CoV-2 N, E, and ORF1a genes in nasopharyngeal swabs, oropharyngeal swabs, anterior nares swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirates, and bronchoalveolar lavage specimens.

The EUA was later updated to reflect the test's removal of ORF1a as a target and include the use of Color's COVID-19 Test Unmonitored Collection Kit for the self-collection of nasal swab specimens at home or in a healthcare setting.

This week's reissuance removes the Color COVID-19 Unmonitored Collection Kit from the EUA due to the kit's recent authorization on its own, as well as updates the SARS-CoV-2 test's intended use to include dry nasal swabs self-collected at home or in a healthcare setting using the Color COVID-19 Self-Swab Collection Kit when deemed appropriate by a healthcare provider. 

Use of the test remains limited to Burlingame, California-based Color.