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Herald Sun
7 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
News.com.au
29-04-2025
- Business
- News.com.au
Biocurious: Lumos shines a light on the post-pandemic rapid diagnosis sector
Lumos is commercialising its FDA-approved Febridx test to distinguish between viral and bacterial infections The company's original Viradx flu assay was affected by a flood of cheap Chinese tests Lumos is also developing a test to predict – and prevent – premature births Lumos Diagnostics (ASX:LDX) CEO Doug Ward knows too well how quickly the competitive landscape for a medical device can change – and he has learnt some valuable lessons from the experience. A year ago, the point-of-care diagnostics house was riding its fortunes on the back of Viradx, its US Food & Drug Administration (FDA) approved test for Covid and influenza A and B. But a flood of Chinese and South Korean companies entered the US market, ahead of the last flu season. While users liked Viradx, Lumos was forced to drop its price from US$12 to test to US$9 – but the rivals were selling theirs for US$3. 'They are now selling at a third of what our product sold at last year,' says the US-based Ward. 'It's not a robust market for us.' Despite this aggressive pricing, Lumos reports new customer adoption owing to the severe US flu season. Tapping his healthcare experience over three decades, Ward has focused Lumos's attention on its Febridx test, which can distinguish between bacterial and viral infections in ten minutes. This is done by measuring two biomarkets simultaneously. Approved by the FDA in October 2023, Febridx targets the over-use of antibiotics which contributes to the huge problem of antimicrobial resistance. Let there be light Lumos is a spin-off from the Melbourne-based Planet Innovation, which has a sound reputation for medical device design and development. Lumos is chaired by Planet Innovation CEO Sam Lanyon. Meaning 'light', Lumos debuted at the height of the pandemic in July 2021, having raised $63 million. Lumos specialises in rapid point-of-care (POC) tests, to help healthcare professionals diagnose and manage medical conditions more accurately. The kits are lateral flow, which means the sample flows horizontally over a strip containing the test reagents. Lumos's offerings include customised assay development and manufacturing services for third-party POC tests, as well as proprietary digital reader platforms. Andrew and Nicola Forrest's Tenmile Ventures last year became a 19.9% Lumos shareholder, having acquired its stake from Planet Innovation. Let's be CLIA – it's important The FDA's Febridx approval came after the agency initially rejected Lumos's submission, in 2022. The agency opined that while the assay proved its chops at the bacterial-versus-viral bit, the agency was worried about false negative Covid results. 'The knock-back was a surprise because we met all the performance endpoints,' says Ward. There's a complexity, in that the company had requested a so-called CLIA (Clinical Laboratory Improvements Amendment ) waiver. The provision is for simple tests that have an insignificant risk of an erroneous result and can be used by less trained staff such as nurses and receptionists. 'It still needs to be in a healthcare setting, but that's it,' says Ward. Other examples of CLIA assays are blood glucose, urine pregnancy and bowel cancer poo tests. Currently, the FDA approval relates to 'moderate to complex' uses by a trained clinician. Ward says the current market accounts for only 5% of the US$1 billion a year addressable market. 'That's why a why a CLIA waiver is so important to us,' says Ward. 'It will transform the company, big time.' US government backed? You BARDA believe it In its quest for CLIA status, Lumos in December launched a supportive study, with 350 patients tested to date. The US disaster preparation agency, BARDA, is ponying up US$3 million to run the trial (contingent on various milestones). The agency is also contributing up to US$5.3 million for a paediatric study. While the trial is progressing well, there has not been enough bacteria-positive patients to power the study properly. One reason is the bad but late US flu season meant here was over-representation of viral patients. In its March quarterly report yesterday, the company reported that of the 351 patients tested to date, 37 had a bacterial infection, whereas a minimum 120 'bacterials' are needed to prove statistical significance. Fortunately, the FDA has allowed an 'enrichment' process, by which Febridx can confirm patients already known to have the streptococcal A bacterial infection. 'Hopefully that will move us along a lot quicker,' says Ward. The company targets study completion – and an FDA filing – in the December half. Febridx addresses the issue of rampant over-use of antibiotics. According to the US Centers for Disease Control and Prevention, more than 200 million antibiotic prescriptions are written each year. About half are for acute respiratory tract infections and about 40% are unnecessary. Women's health Lumos's s next foray is in women's health, in collaboration with the Massachusetts-based women's' health specialist, Hologic. The parties are developing a next-generation test for foetal fibronectin (FFN), a biomarker that points to a higher risk of pre-term births. Under a US$10 million agreement, Lumos has licensed its proprietary reader and POC tech to Halogic. Lumos also has dibs on up to US$5.5 million of milestone-based development payments from Halogic over two years. The assay would replace the Halogic's current ageing FFN test, which is the only one on the market. Lumos says the FFN work is 'progressing well', albeit about four months later than planned. Old friends In early 2023 the then cash-strapped Lumos vended some of the manufacturing equipment at its Carlsbad, California facility to Hologic, under a sale and leaseback arrangement. This resulted in a $5.9 million in non-dilutive funding. Hologic and Lumos know each other well, because Ward was business development manager for Hologic and Hologic was one of Lumos's biggest customers. 'There is a roadmap to develop other products with them as well,' says Ward. 'There's no point having a reader in a clinic only able to do one test, it takes up too much space.' Outside of the Hologic tie-up, Lumos is mulling its own suite of women's health tests, for conditions including urinary tract and yeast infections and vaginitis. 'Most of these tests are done and sent to the lab and it takes days for a turnaround,' says Ward. The company plans five to six tests, with the first two to be revealed in the December half. Getting paid As we've opined previously, regulatory approval amounts to a hill of beans without robust reimbursement in place. In April Lumos secured Febridx reimbursement coverage for four Medicare Administration Contractors (MACs), at US$41.38 per test. This takes coverage to four of the seven MACs, or 55% of total Medicare coverage. Management is confident of snaring the remaining three. 'Medicare adoption generally serves as a precedent for reimbursement decisions by private insurance payors,' notes Lumos. Febridx will drive growth Lumos posted March quarter revenue of $3.5 million, 21% better than the December quarter tally. Cash outflows were US$1.3 million, compared with a US$3.7 million deficit previously. Of the revenue, 80% was derived from contract services for drug, diagnostic, food and environmental testing companies. A company review in mid 2022 enunciated the services side as a key priority. Having said that, Febridx offers the strongest growth prospects in a world in which clinicians and patients want an answer now, rather than when the lab decides to return a result. Research platform MST Access says: 'the global healthcare system increasingly is prioritising rapid diagnostic solutions, particularly in infectious disease management and antibiotic stewardship. 'Lumos's proprietary technology addresses this need with point-of-care solutions that reduce the time to diagnosis and treatment.'
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.
