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Quest Diagnostics Gets FDA Emergency Use Authorization for COVID-19 Sample Collection Kit

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a SARS-CoV-2 molecular testing sample collection kit from Quest Diagnostics.

The Quest COVID-19 Nucleic Acid Test Collection Kit is designed for the self-collection of anterior nasal swab specimens for use with tests that detect SARS-CoV-2 nucleic acid. The kit includes specimen collection and storage materials, as well as instructions for returning the kit to a drop-off location, according to the FDA.

Secaucus, New Jersey-based Quest has received EUAs from the FDA for a number of COVID-19 testing products including three direct-to-consumer tests and accompanying home sample collection kit about a year ago.

The company said last month that its COVID-19 testing revenues were down 75 percent year over year in 2022 and are expected to be down between 81 and 88 percent year over year in 2023.