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.
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