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Phosphorus Diagnostics Gets FDA EUA for Direct-to-Consumer Coronavirus Test, Sample Collection Kit

NEW YORK — Phosphorus Diagnostics on Monday received Emergency Use Authorization from the US Food and Drug Administration for a direct-to-consumer version of its saliva-based SARS-CoV-2 assay, as well as for an at-home sample collection kit that can be used with the test.

The Phosphorous COVID-19 RT-qPCR Test DTC is designed to detect the N gene of the virus in saliva samples collected at home, including in a community-based setting. It runs on Bio-Rad Laboratories' CFX384 Touch Real-Time PCR Detection System and may be used only by Phosphorus-designated labs that are CLIA-certified to perform high-complexity tests, according to the FDA.

Samples used with the test are self-collected using the Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC, which also received FDA EUA on Monday. The kit includes a sample collection device, instructions for use, and shipping materials.

The prescription-only version of Phosphorus' DTC test, which uses saliva samples collected at home using OraSure Technologies' DNA Genotek Oragene Dx OGD-510 collection kit, received EUA from the FDA in mid-2020. A few months later, Secaucus, New Jersey-based Phosphorus inked a deal to offer this test at Albertsons Companies' in-store pharmacies.