www.fdanews.com/articles/204532-fda-declines-eua-for-lumos-diagnostics-covid-19-test
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.