The company provides customised assay development along with manufacturing services for POC tests and digital reader platforms. Credit: National Cancer Institute on Unsplash.

The US Food and Drug Administration (FDA) has granted approval for Lumos Diagnostics’ FebriDx rapid point-of-care (POC) test.

The approval allows the marketing of the test for use by healthcare professionals in the country.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Healthcare professionals can use FebriDx for diagnosing bacterial acute respiratory infection and differentiating it from non-bacterial aetiology in patients in emergency or urgent care settings.

FebriDx is intended for use along with clinical signs and symptoms, including other laboratory and clinical data, to assess patients for acute respiratory infection.

The corporation submitted a new 510(k) application for the test to the FDA after a presubmission meeting in January this year.

After reviewing, the regulator determined that the test has shown significant equivalence to the predicate device mentioned in the application.

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.

FebriDx test is already registered in Australia, Malaysia, Singapore, Pakistan, Turkey, Brazil, UAE, Canada, Europe and the UK.

Lumos Diagnostics CEO Doug Ward said: “It is a credit to the regulatory team at Lumos that we have been able to deliver this outcome from our new 510(k) application significantly ahead of our initial expectations.

“With this clearance in hand, we anticipate securing our first commercial orders in the US before the end of calendar year 2023.

“In the meantime, we are continuing to work with distribution partners and potential licensees, as well as establish our own focused sales effort, as we prepare to launch FebriDx in the US.”

The company provides customised assay development along with manufacturing services for POC tests and digital reader platforms.