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FDA Declines EUA for Lumos Diagnostics’ COVID-19 Test

September 24, 2021

Lumos Diagnostics has received a letter from the FDA saying that the agency has stopped reviewing the company’s request for an emergency use authorization (EUA) for the company’s CoviDx SARS-CoV-2 rapid antigen test.

The Sarasota, Fla.-based company said it is communicating with the FDA and preparing additional data to support the EUA application for the rapid test which already has a CE mark and is undergoing regulatory reviews in other markets.

Separately, Lumos said it is completing development of its ViraDx point-of-care assay which can simultaneously test for COVID-19 and influenza.

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