LMDX - LumiraDx gets EU's CE mark for its low-cost COVID-19 test the Amira System

LumiraDx (NASDAQ:LMDX) on Thursday said it had got the European Commission's CE Mark for its Amira System, a low-cost COVID-19 test. The CE marking signifies that products sold in the European Economic Area have been "assessed to meet high safety, health, and environmental protection requirements." This is London-based LMDX's latest CE mark for one of its diagnostic products following several such approvals this year. Only yesterday, the company said it had got the CE mark for two of its COVID/influenza tests. The CE marking for the Amira System covers only professional use for now at a point of care. LMDX said it plans to seek additional regulatory approvals for the system, including those for non-professional, over-the-counter use. LMDX said the system involves an analyzer that can read the SARS-CoV-2 test strips and return a result in just 15 minutes. LMDX stock +5.8% to $4.53 in premarket trading. It had ended 10.3% higher in the previous session.

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LumiraDx gets EU's CE mark for its low-cost COVID-19 test, the Amira System