LumiraDx (LMDX) Receives FDA Emergency Use Authorization and UK CTDA Approval for its Fast Lab Solutions Multiplex COVID and Influenza Molecular Assay

LumiraDx Limited (Nasdaq: LMDX) today announced that it has received an Emergency Use Authorization from the U.S. Food and Drug Administration and validation for use by the UKHSA under the CTDA process for the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay that will allow high complexity laboratories to quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly.

The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete multiplex test allows for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 infections within 20 minutes or less. The assay takes advantage of the innovative qSTAR technology which utilizes a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments which will be a powerful diagnostic tool for this respiratory season.

LumiraDx launched the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay in the European Union and other markets that accept CE-IVD in June 2022 and will now begin commercialization of the test in the U.S. and U.K.

“With the limited number of direct amplification multi-analyte tests available, we believe that this test will become a fundamental tool for the detection and differentiation of SARS-CoV-2 from influenza,” explains Sanjay Malkani, President of the LumiraDx Molecular Diagnostics Business. “As the burden of respiratory illness continues, we look forward to providing our clinical diagnostic lab and reference lab customers with a high-throughput, highly sensitive multiplex test with results available in 20 minutes - and the added benefit of accurately detecting influenza and COVID from a single sample.”

The company plans to commence commercial shipments imminently.

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