LMDX - LumiraDx wins U.S. U.K. nod for COVID/flu assay

• LumiraDx Limited ( NASDAQ: LMDX ) added ~9% pre-market Monday after announcing U.S. and U.K. regulatory clearances for a diagnostic assay that allows the simultaneous detection of COVID-19 and influenza viruses.
• With the Emergency Use Authorization (EUA) by the FDA and validation for use by the U.K. regulators, LumiraDx ( LMDX ) expects to launch the product imminently.
• Branded as LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay, the test differentiates and detects influenza A, influenza B, and SARS-CoV-2 infections, generating results within 20 minutes, the company said.
• With signs and symptoms of COVID and flu being similar, the correct identification of patients is key to determining the appropriate clinical care, LumiraDx ( LMDX ) added.
• The company launched the product in the European Union last year after receiving the CE marking in June.

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