Lumos passes milestone in CLIA waiver
Lumos enrols 61 of required 120 bacterial positive patients in US CLIA waiver clinical study for FebriDx
Study to be completed by Q4 2025 with US FDA CLIA waiver application to be submitted in October 2025
Successful CLIA waiver would unlock access to a US total addressable market exceeding US$1 billion
Special Report: Lumos Diagnostics has passed a major milestone in a US CLIA waiver study for its rapid point-of-care diagnostic FebriDx designed to differentiate between bacterial and non-bacterial acute respiratory infections.
Developer of rapid, point-of-care testing Lumos Diagnostics (ASX:LDX) has achieved 61 bacterial positive patients representing 50% of the target of 120 bacterial positive patient results required for its ongoing CLIA waiver study.
Lumos said there had been 439 patients enrolled in the study and testing of the 500th patient would trigger a US$298,457 milestone payment from its partner, the Biomedical Advanced Research and Development Authority (BARDA).
The bacterial prevalence rate in the study so far is at an average of 14% (61/439).
However, since Lumos implemented its enrichment strategy in late March the company said the bacterial prevalence rate in the trial had been around 35%.
This study is a critical step towards securing a CLIA waiver from the US Food and Drug Administration (FDA).
It would enable FebriDx to be used in a broader range of healthcare settings, including physician offices, urgent care clinics or other outpatient clinics that do not operate under high-complexity laboratory certification.
At the current accrual rate, Lumos said the study was anticipated to conclude in Q4 2025.
Subject to successful data outcomes, Lumos expects to submit its CLIA waiver application to the FDA in Q4 2025.
Addressing overuse of antibiotics
FebriDx is a unique, rapid test that helps clinicians differentiate between bacterial and non-bacterial acute respiratory infections through a simple fingerstick blood sample, delivering results quickly at the point-of-care.
The test enables clinicians to make more informed treatment decisions at the initial point of care, supporting appropriate antibiotic stewardship and helping to combat the global challenge of antimicrobial resistance.
By aiding clinicians in faster, better decisions at the point-of-care, Lumos said FebriDx had the potential to improve patient outcomes, reduce unnecessary antibiotic prescriptions, and lower overall healthcare costs.
The World Health Organization has warned that the global surge in antibiotic resistance is undermining the effectiveness of commonly used antibiotics to treat widespread bacterial infections.
Lumos said in the US antibiotic-resistant infections caused ~2.8 million illnesses and 35,000 deaths each year.
'Encouraged by the progress'
Managing director Doug Ward said reaching the halfway mark in bacterial positive patient recruitment for its CLIA waiver clinical study was an important achievement for Lumos.
'We are encouraged by the progress of the study with the support of BARDA and remain focused on delivering a successful outcome that expands the availability of FebriDx to clinicians and patients across the US,' he said.
"A successful CLIA waiver would unlock access to a US total addressable market exceeding US$1 billion and significantly expand the commercial potential for FebriDx in point-of-care settings by up to 15 times our current available market opportunity."
He said the company continues to work closely with its clinical partners to complete enrolment and data collection in a timely manner.
Lumos recently announced it had Medicare reimbursement from six of seven Medicare administrative contractors, representing more than 85% of total US Medicare payment coverage.
This article was developed in collaboration with, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Originally published as Lumos passes milestone in CLIA waiver study for point-of-care respiratory test
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