FDA CLIA Waiver for FebriDx unlocks US$1B+ U.S. opportunity
27 March 2026
Lumos Diagnostics has today announced that U.S. FDA has granted 510(k) clearance with CLIA waiver for FebriDx®, enabling broader use across frontline healthcare settings and significantly expanding its commercial opportunity.
This approval extends the reach of FebriDx® to more than 300,000 healthcare locations and an estimated 80 million patients annually, unlocking a U.S. market opportunity of over US$1.0 billion – approximately 15 times larger than previously accessible.
The milestone triggers US$5.5 million in payments to Lumos, including US$5.0 million from PHASE Scientific, reinforcing the strength of our partnerships and supporting the U.S. rollout.
This also activates the Company’s U.S. strategy, with our partnership with PHASE Scientific now moving into full commercial execution, alongside continued support from BARDA.
Doug Ward, CEO of Lumos Diagnostics, said:
“The FDA’s granting of a CLIA waiver for FebriDx® marks a transformative moment for Lumos and for the management of acute respiratory infections in the U.S. healthcare system. This approval opens access to a vastly larger market - allowing healthcare professionals in outpatient clinics to deliver rapid and accurate results at the time of the consultation, delivering more effective patient outcomes.”
Click to read the ASX release
This approval extends the reach of FebriDx® to more than 300,000 healthcare locations and an estimated 80 million patients annually, unlocking a U.S. market opportunity of over US$1.0 billion – approximately 15 times larger than previously accessible.
The milestone triggers US$5.5 million in payments to Lumos, including US$5.0 million from PHASE Scientific, reinforcing the strength of our partnerships and supporting the U.S. rollout.
This also activates the Company’s U.S. strategy, with our partnership with PHASE Scientific now moving into full commercial execution, alongside continued support from BARDA.
Doug Ward, CEO of Lumos Diagnostics, said:
“The FDA’s granting of a CLIA waiver for FebriDx® marks a transformative moment for Lumos and for the management of acute respiratory infections in the U.S. healthcare system. This approval opens access to a vastly larger market - allowing healthcare professionals in outpatient clinics to deliver rapid and accurate results at the time of the consultation, delivering more effective patient outcomes.”
Click to read the ASX release
