LumiraDx has submitted an application to the US Food and Drug Administration (FDA) seeking Emergency Use Authorization (EUA) for its LumiraDx SARS-CoV-2 & Flu A/B Test.
This rapid microfluidic immunofluorescence assay can run on the LumiraDx point of care platform.
It is developed for detecting and differentiating the SARS-CoV-2, Influenza A and Influenza B viral antigens simultaneously.
The LumiraDx SARS-CoV-2 & Flu A/B Test uses nasal swab specimens and verifies infection in individuals suspected of flu and/or Covid-19 within the initial 12 days from the first symptoms.
As it provides results in just 12 minutes, it can allow clinicians to take quick treatment decisions.
LumiraDx CEO Ron Zwanziger said: “Both Covid and flu infections can present with similar symptoms, but the clinical pathways are different.
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“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 new LumiraDx test is supported by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative.
It has been partly funded with federal funds obtained from the NIH, Department of Health and Human Services, and National Institute of Biomedical Imaging and Bioengineering.
At present, LumiraDx has five tests in markets across the world, with ten more scheduled for regulatory submission or approval by the end of next year.
Among those awaiting approval are tests for congestive heart failure and troponin.
In August, LumiraDx’s SARS-CoV-2 antibody (Ab) test received EUA from the US FDA for detecting total antibodies induced in response to Covid-19 infection.