Latest news with #FebriDx
Herald Sun
6 days ago
- Business
- Herald Sun
Lumos passes milestone in CLIA waiver
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. 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
The Australian
23-04-2025
- Business
- The Australian
Medicare coverage advances for Lumos's FebriDx
Lumos secures reimbursement coverage for FebriDx from two additional Medicare Administration Contractors US reimbursement coverage now achieved with four of seven Medicare Administration Contractors Momentum continues with negotiations in process with remaining three Special Report: Lumos Diagnostics is continuing to advance the US reimbursement pathway for its FebriDx test, a rapid point-of-care diagnostic designed to differentiate between bacterial and non-bacterial acute respiratory infections. Lumos Diagnostics (ASX:LDX) has announced it has received confirmation of Medicare reimbursement coverage from two additional Medicare Administrative Contractors (MACs), First Coast Service Options (FCSO) and Noridian Healthcare Solutions (Noridian). The company said FebriDx would be added to the Medicare fee schedules at of FCSO and Noridian, with coverage backdated to April 1, 2025. FCSO is responsible for managing Medicare payments in the state of Florida. Noridian provides coverage across a wide geographic region that includes California, Nevada, Oregon, Washington, Idaho, Montana, Utah, Arizona, Wyoming, North Dakota, South Dakota, Alaska and Hawaii. The inclusion of the two MACs adds to coverage from Novitas and Palmetto announced last week. Lumos said it now had Medicare reimbursement from four of the seven MACs, representing over 55% of the total US Medicare payment coverage. Pic: Lumos Diagnostics Set reimbursement rate for FebriDX Coverage by the MACs follows the Centers for Medicare & Medicaid Services (CMS) including FebriDX in the 2025 Clinical Lab Fee Schedule (CLFS). Under the CLFS, a proprietary laboratory analyses (PLA) code (0442U) was set for FebriDX to be reimbursed at a rate of US$41.38 per test from January 1. Lumos said the CMS set PLA code was a pivotal milestone in securing reimbursement for FebriDx from both government and private insurers. Momentum in its commercialisation efforts significantly expands Lumos' access to the Medicare patient population. Medicare adoption often sets a precedent for private insurers, paving the way for broader reimbursement acceptance. The company said reimbursement coverage, particularly from private payors, traditionally followed real-world use. Addressing antibiotic resistance FebriDx enables point-of-care differentiation between bacterial and non-bacterial infections – a critical capability given that most acute respiratory infections are viral in nature and do not require antibiotics. Despite this, antibiotics are still prescribed in up to 50% of these cases, fuelling the growing challenge of antibiotic resistance. The World Health Organization has warned that the global rise in antibiotic resistance poses a major threat to public health, reducing the effectiveness of commonly used antibiotics against widespread bacterial infections. Managing director Doug Ward said securing additional Medicare coverage from FCSO and Noridian for FebriDx reinforces its commitment to developing a POC diagnostic solution that benefits patients, but also integrates seamlessly into care pathways and delivers value to the broader health system. 'Lumos remains committed to securing adoption from the remaining three MACs and pursuing reimbursement coverage from private payors, with the goal of achieving nationwide access for patients and supporting broad clinical adoption of FebriDx,' he said. This article was developed in collaboration with Lumos Diagnostics, 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.
