FDA grants EUA for at-home saliva test to detect SARS-CoV-2

June 10, 2020

Phosphorus, a genomic testing startup, announced that it has been granted an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for an at-home saliva test to detect SARS-CoV-2, according to the company’s press release.

Consumers can order the test online and will be prompted to fill out a medical questionnaire, which will be reviewed by physicians. Providers and employers also can order the test for at-home collection by patients.

The RT-qPCR test was developed at Phosphorus’ CLIA-certified laboratory in Secaucus, NJ, using the OraSure’s OrageneDx (OGD-510) saliva collection device.

In May, the FDA granted an EUA for a saliva test developed at Rutgers Clinical Genomics Laboratory. Saliva specimens for Rutgers’ test – which uses the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device –can be collected either at-home or in a healthcare setting.

The FDA’s EUA also covered Rutgers’ TaqPath SARS-CoV-2 test for specimen collection using nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate nasal swabs.

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