FDA Rejects Lumos Appeal for FebriDx
Lumos Diagnostics failed in its appeal of an FDA decision not to grant clearance to the company’s FebriDx product for use in differentiating bacterial from viral infections in point-of-care settings.
The agency upheld its original decision that the company failed to demonstrate the product’s substantial equivalence to the predicate device.
Given the likely requirements of further investment and time to generate additional data, the company said it plans to direct its efforts to commercialize FebriDx in global markets where it already has clearance.
“For the time being, Lumos does not intend to further invest in activities directed towards securing U.S. clearance for FebriDx,” the company said.