Original from: Lumos Diagnostics
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 ¨C 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.¡±
Source: FDA CLIA Waiver for FebriDx unlocks US$1B+ U.S. opportunity
