The rapid microfluidic immunofluorescence assay will facilitate the simultaneous identification of SARS-CoV-2, Influenza A, and Influenza B viral antigen directly from self or clinician collected nasal swab specimens
LumiraDx is seeking an EUA from the US FDA for its SARS-CoV-2 & Flu A/B rapid antigen test. (Credit: Gerd Altmann from Pixabay)
LumiraDx is seeking an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 & Flu A/B rapid antigen test.
The company has submitted an application to the regulator to receive EUA status for the microfluidic immunofluorescence assay, which holds the capacity to verify infection in patients suspected of flu and Covid-19.
Designed to operate on the LumiraDx Point of Care Platform, the rapid microfluidic immunofluorescence assay will facilitate the simultaneous identification of SARS-CoV-2, Influenza A, and Influenza B viral antigen directly from self or clinician collected nasal swab specimens.
The specimens are gathered from individuals suspected of viral infection consistent with Covid-19 by their healthcare provider within the first 12 days of the onset of symptoms.
LumiraDx CEO Ron Zwanziger said: “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.”
At present, the company markets five tests across the globe and is having an additional 10 tests for regulatory submission or clearance by the end of next year, including tests for troponin and congestive heart failure.
Supported by the NIH Rapid Acceleration of Diagnostics (RADx) initiative, the LumiraDx SARS-CoV-2 & Flu A/B Test has also secured funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services.
In August this year, LumiraDx secured an EUA from the US FDA for its point-of-care Covid-19 antigen test.