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May 11, 2020

Rutgers assay receives full emergency approval from FDA

By Chloe Kent

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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