Australian diagnostics company Lumos Diagnostics announced this week that it has received US Food and Drug Administration (FDA) marketing clearance for a rapid diagnostic test that helps clinicians determine when antibiotics are needed for respiratory infections.
Disposable rapid test
The FDA clearance means that FebriDX, a disposable point-of-care immunoassay designed to aid diagnosis of acute bacterial respiratory infections, can now be marketed in the United States for use by healthcare providers in urgent care and emergency care settings. Company officials say the test, which differentiates bacterial- from viral-associated host immune response and is intended to be used in conjunction with clinical signs and symptoms, could help improve antibiotic prescribing for acute respiratory infections.
The inappropriate and unnecessary prescribing of antibiotics is recognised as a significant contributing factor to the growing global emergence of antimicrobial resistant (AMR) strains of bacterial pathogens. Although acute respiratory infections are predominantly viral in origin, they are the most common diagnosis for which outpatient antibiotics are prescribed.
“We are delighted to finally secure clearance to market our FebriDx rapid, point-of-care test in the US as we continue to believe it has an important role to play in antibiotic stewardship,” said Lumos CEO Doug Ward in a company press release.
Read more at the University of Minnesota Center for Infectious Disease Research & Policy.