Rutgers assay receives full emergency approval from FDA

11 May 2020 (Last Updated May 11th, 2020 11:39)

The US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) to Rutgers Clinical Genomics Laboratory for its Covid-19 laboratory developed test (LDT). In April, the test was added to the high complexity molecular-based LDT ‘umbrella’ EUA to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.

The FDA has stressed that this is not a general authorisation for at-home sample collection. The EUA permits the testing of a sample collected from a patient using only the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device self-collection kit, which must be returned directly to the Rutgers Clinical Genomics Laboratory. The test remains prescription-only.