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Lumos Diagnostics Holdings Ltd. ( (AU:LDX) ) has issued an announcement.
Lumos Diagnostics has submitted a CLIA waiver application to the U.S. FDA for its FebriDx® test, which distinguishes between bacterial and non-bacterial respiratory infections. The submission follows successful clinical trials and triggers significant milestone payments from BARDA and PHASE Scientific. If granted, the waiver could expand Lumos’s U.S. market opportunity fifteen-fold to over $1 billion, enhancing its industry positioning and stakeholder value.
More about Lumos Diagnostics Holdings Ltd.
Lumos Diagnostics specializes in rapid, point-of-care diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions. Lumos offers customized assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercializes novel Lumos-branded point-of-care tests that target infectious and inflammatory diseases.
Average Trading Volume: 5,357,236
Technical Sentiment Signal: Buy
Current Market Cap: A$82.34M
Learn more about LDX stock on TipRanks’ Stock Analysis page.