The US Food and Drug Administration (FDA) on Friday granted the first emergency use authorization (EUA) allowing for at-home saliva sample collection for a coronavirus disease (COVID-19) diagnostic and opened the door to wider at-home sample collection.
The EUA allows Rutgers Clinical Genomics Laboratory to use its TaqPath SARS-CoV-2 Assay, which was previously covered under the umbrella EUA for laboratory developed tests (LDT) for COVID-19, to test home collected saliva samples using the Spectrum Solutions LLC SDNA-1000 saliva collection device.
While the test is authorized for at-home sample collection, a prescription is required, and the EUA limits testing to be performed only at Rutgers’ laboratory.
FDA says it issued a separate EUA authorizing the test for use with home collected saliva samples as the revised use is “beyond the scope” of the LDT umbrella EUA, which does not allow for home-based testing or at-home sample collection. (RELATED: FDA: Flexible COVID-19 testing policy doesn’t apply to at-home tests, Regulatory Focus 24 March 2020)…