LumiraDx (LMDX) Announces FDA EUA Submission for its SARS-CoV-2 & Flu A/B Rapid Antigen Test
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LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostic company, today announced it has submitted the LumiraDx SARS-CoV-2 & Flu A/B Test to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The microfluidic immunofluorescence assay can quickly verify infection for patients suspected of flu and/or COVID-19 to aid diagnosis and clinical decision making.
Run on the LumiraDx Point of Care Platform, the LumiraDx SARS-CoV-2 & Flu A/B Test is a rapid microfluidic immunofluorescence assay intended for the simultaneous detection of SARS-CoV-2, Influenza A, and Influenza B viral antigen direct from self or clinician collected nasal swab specimens from individuals suspected of viral infection consistent with COVID-19 by their healthcare provider within the first 12 days of the onset of symptoms.
Ron Zwanziger, LumiraDx Chief Executive Officer explained, "Both COVID and Flu infections can present with similar symptoms, but the clinical pathways are different. As we approach the flu season, fast and reliable multi-analyte diagnostic testing may allow healthcare professionals to better triage patients and guide optimal treatment decisions."
The SARS-CoV-2 & Flu A/B Test is one of a growing number of assays run on the LumiraDx Platform. The company currently has five tests in the market globally, and an additional 10 tests scheduled for regulatory submission or clearance by the end of 2022, including tests for troponin and congestive heart failure.
The LumiraDx SARS-CoV-2 & Flu A/B Test is supported by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative and has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00034.
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