The FDA has granted two more companies’ COVID-19 tests emergency use authorizations.
Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval.
Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., and Marlborough, Mass., to Quest labs in Dallas, Texas; Teterboro, NJ; Miami; Los Angeles; Chicago; Kansas City; Pittsburgh; and Phoenix by the end of March. Other laboratories may also purchase the test.
“We expect to have capacity to perform approximately 10,000 tests a day by the end of next week and approximately 20,000 tests a day by the end of the month,” the company said in a news release.
San Diego-based Quidel said its Lyra SARS-CoV-2 assay’s PCR reagents provide for simple transport and storage, improved workflow, shorter time to result and other benefits that favorably affect diagnostic test outcome. Quidel touted its test as offering “certain additional advantages over other tests currently on the market for this novel coronavirus, including easier setup and faster time to result.”
“The feature benefits of the test system and the Lyra product will contribute substantially to our country’s efforts to fight this pandemic,” said Quidel president & CEO Douglas Bryant in a news release. “We are proud to have quickly developed this assay in mere weeks, and to have manufactured kits, several of which are in transit to customers. Anticipating significant demand, we are allocating kits across a broad set of customers as we ramp production.”
The Lyra SARS-CoV-2 Assay is only available for sale in the U.S. through Quidel or Cardinal Health.