Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.
- CLIA waiver application submitted to U.S. FDA for FebriDx®
- Clinical trial shows over 98% concordance between trained and untrained users
- Milestone payments of approximately US$2.75 million triggered from BARDA and PHASE Scientific
- FDA feedback expected by end of Q1 2026
- Potential U.S. market expansion to over US$1 billion if waiver granted
Lumos Advances Regulatory Milestone
Lumos Diagnostics Holdings Ltd (ASX, LDX) has taken a significant step forward by submitting its application for a Clinical Laboratory Improvement Amendments (CLIA) waiver to the U.S. Food and Drug Administration (FDA) for its rapid diagnostic test, FebriDx®. This move follows the completion of a pivotal clinical study designed to demonstrate the test’s ease of use and reliability when operated by untrained users.
Strong Clinical Data Supports Application
The clinical trial results were compelling, showing a 99.1% concordance rate between trained and untrained operators for bacterial positive patients, and 98.4% concordance for non-bacterial cases. These figures underscore FebriDx®’s potential as a simple, point-of-care diagnostic tool that can reliably differentiate bacterial from non-bacterial respiratory infections in about 10 minutes. Such performance is critical for achieving the CLIA waiver, which would allow the test to be used in a broader range of healthcare settings without the need for specialized laboratory personnel.
Financial Milestones and Market Potential
The submission has already triggered milestone payments totaling approximately US$2.75 million from key partners. The Biomedical Advanced Research and Development Authority (BARDA) will provide around US$1.25 million shortly, with an additional US$507,000 contingent on FDA approval. Meanwhile, PHASE Scientific has committed a US$1.5 million product prepayment milestone, with a further US$5 million prepayment due upon waiver grant. These payments provide a strong financial boost ahead of the FDA’s decision, expected by the end of the first quarter of 2026.
Expanding the U.S. Market Opportunity
If FebriDx® secures the CLIA waiver, Lumos estimates the addressable U.S. market will expand approximately fifteen-fold to over US$1 billion. This dramatic increase reflects the broader accessibility and usability of the test in outpatient clinics, urgent care centers, and other non-laboratory environments. The potential to reduce unnecessary antibiotic prescriptions by quickly distinguishing bacterial infections aligns with growing healthcare priorities around antimicrobial stewardship.
Looking Ahead
CEO Doug Ward expressed optimism about the milestone, highlighting the collaborative effort with BARDA and the Lumos team. While the FDA’s review process remains a critical next step, the company’s progress positions it well to capitalize on a significant market opportunity. Investors and industry watchers will be keenly awaiting the FDA’s feedback, which could mark a turning point for Lumos Diagnostics and its flagship product.
Bottom Line?
The FDA’s CLIA waiver decision will be a pivotal moment, potentially unlocking a multi-billion-dollar U.S. market for Lumos.
Questions in the middle?
- Will the FDA grant the CLIA waiver as anticipated by Q1 2026?
- How will Lumos scale production and distribution if the waiver is approved?
- What competitive responses might emerge in the point-of-care respiratory diagnostics space?