NEW YORK — The US Food and Drug Administration last week issued Emergency Use Authorizations for direct-to-consumer versions of Color Health's loop-mediated isothermal amplification-based SARS-CoV-2 test and a companion nasal swab sample self-collection kit.
The prescription-only Color SARS-CoV-2 RT-LAMP Diagnostic Assay was first authorized last year for the detection of the N, E, and ORF1a genes of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal washes or aspirates, nasal aspirates, and bronchoalveolar lavage specimens.
That authorization was later updated to reflect the removal of ORF1a as a target and include the use of samples collected using Color's COVID-19 Test Unmonitored Collection Kit for sample self-collection, then updated again to include the use with the Color COVID-19 Self-Swab Collection Kit when deemed appropriate by a healthcare provider.
The newly authorized Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC can be sold without a prescription and is used with anterior nasal swab samples self-collected with the now-authorized direct-to-consumer version of the Color COVID-19 Self-Swab Collection Kit.
The DTC test may only be performed by Burlingame, California-based Color's lab, according to the FDA.