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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.