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.
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.
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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.