Latest news with #FebriDx
West Australian
18-07-2025
- Business
- West Australian
ASX Runners of the Week: Lumos, Tali Resources, Osteopore & ClearVue
New record highs on the ASX? Yawn. Market speculators are at it again, betting big on an 'inevitable' August interest rate cut after Australian employment figures came in softer than a summer breeze. The Reserve Bank is being cautious and still wants to eyeball the quarterly inflation data before it jumps. But the market's already off to the races, soaring more than two per cent from Thursday morning like it's got somewhere to be. Tech and healthcare sectors were the week's winners, gaining 2.5 and 2 per cent respectively, while more importantly snagging three of the four Runners spots this week. The world's biggest miner BHP was also smashing records as its newest South Flank mine amazingly ran above nameplate capacity in its first year. The company says it has also pumped out some 2 million tonnes of copper group-wide, a record haul for the red metal that's flying thanks to United States President Donald Trump and his favourite word – tariffs. DroneShield soared on the week as defence stocks continue to boom in 2025. The counter-drone technology company stacked 30 per cent onto its share price on the announcement that its Sydney-based production facility will expand. At the smaller and more exciting end of the market, the long underperforming small caps sector is stirring from its nearly three-year hibernation. Just 29 new listings were made in 2024 – the lowest number in 20 years. This week saw two resources companies hit the boards and fly off the shelves: Gold play Ballard Mining ran up 80 per cent on the week and West Arunta hopeful Tali Resources spiked 125 per cent on day one of its listing Friday. This week's Bulls N' Bears Runners list includes a promising mix from the booming tech and health sectors and the exciting West Arunta newcomer Tali Resources, with the top spot snagged by an innovative diagnostics player scoring big in the promised land of healthcare – the US. LUMOS DIAGNOSTICS (ASX: LDX) Up 176% (2.9c – 8c) Bulls N' Bears' Runner of the Week is healthcare solutions company Lumos Diagnostics, which shot out of a cannon after announcing it had signed a pivotal, exclusive US distribution and supply agreement with PHASE Scientific International, valued up to US$317 million (A$487 million). Lumos is a leader in rapid point-of-care (POC) diagnostic technologies and specialises in developing and commercialising tests to help doctors accurately diagnose and manage infectious diseases. Its flagship product, FebriDx, is a rapid test that differentiates bacterial from viral respiratory infections in just 10 minutes using a finger-stick blood sample. Importantly, the technology could help address antibiotic overuse by providing clear clinical guidance for prescriptions. With operations in the US, mainland China and Hong Kong, PHASE is a multi-billion-dollar player delivering novel diagnostic tools and services for cancer and infectious diseases using proprietary technologies. The agreement is for the exclusive distribution of FebriDx for six years in the juicy US market - news that saw Lumos' share price skyrocket 176 per cent to a high of 8 cents on Wednesday on a massive $6.5 million in stock traded. The agreement comprises a US$1 million (A$1.54 million) non-refundable exclusivity payment on signing and an additional US$7.5 million in non-refundable prepaid purchase orders, payable in three tranches. Punters are betting in droves on Lumos's potential to transform respiratory diagnostics in the world's largest healthcare market. This deal isn't just about dollars and cents, it aligns Lumos with PHASE Scientific's established US network and its proven brand track record of more than 100 million test sales. With antibiotic resistance a growing global concern, Lumos's tech could save healthcare systems billions, while improving patient outcomes. This week's share price surge could be a mere appetiser for what's to come if the US Food and Drug Administration gives a green light. TALI RESOURCES LTD (ASX: TR2) Up 125% (20c – 45c) Diving late at the line to finish a close second is ASX newcomer Tali Resources, which has seen the greatest day-one listing performance in years. The company's share price shot up a massive 120 per cent on Friday after the names behind the West Arunta darling and 100-bagger WA1 Resources moved while the iron is hot to raise $7.5 million to chase giant copper deposits in the red-hot West Arunta region. The West Arunta region, near the Western Australian-Northern Territory border, is Australia's latest geological frontier. Tali, which was spun out of Agrimin Limited and is led by WA1 Resources director Rhys Bradley, says it controls a massive 4000 square kilometres of tenements in the coveted region. The tenements are adjacent to WA1's Luni niobium-rare earths discovery. Tali's mission is strategic exploration to identify large-scale mineral deposits and replicate its previous success, this time with copper as the primary target. Punters clearly see Tali's potential to repeat WA1's success, with its vast tenement package and focus on copper, a metal in red-hot demand for the global clean energy transition. The feeding frenzy on the first day of trading was evident as more than $1 million in stock was traded for to a high of 45c per share from a raising price of 20c.. The $7.5 million war chest gives Tali the firepower to launch aggressive exploration, with drilling plans set to test high-priority targets across its sprawling tenure. Its share price got off to a hot start, already doubling on day one, but Tali still has a long way to go to live up to WA1's dream 2022 IPO. OSTEOPORE LTD (ASX: OSX) Up 100% (1c – 2c) Taking out bronze on this week's Runners of the Week list was regenerative medicine company Osteopore Limited. The company shot out of the gates early after it locked in lucrative market approval for its 3D-printed implants in Switzerland under the European Union's medical device regulations. Osteopore's patent-protected scaffolds are made using a proprietary manufacturing technique with a polymer that naturally dissolves over time as it is replaced by healthy, new growth bone tissue. The bio-resorbable implants stimulate natural bone healing and can be used in neurosurgery, orthopaedics and craniofacial applications to significantly reduce post-surgery complications commonly associated with permanent bone implants. Operating globally, including in Europe, Asia and the US, Osteopore partners with giants such as Zimmer Biomet to distribute its innovative implants. The company's share price doubled on Monday to close at 2c per share up from a close last week of 1c on a handy $1 million in traded stock. The company says its high-value implant range provides market leader Zimmer Biomet with opportunities to offer high-value implants to the Swiss and greater European markets to complement its range of off-the-shelf neurosurgical and craniofacial implants. This week's milestone follows Osteopore's 2023 transition and a 2024 exclusive distribution deal with Zimmer Biomet, completing its portfolio for off-the-shelf and custom implants targeting Europe's US$527.6 million cranial implant market. The market is projected to hit $26.7 billion for custom implants by 2029. Investors jumped on the news, seeing Osteopore's Swiss clearance as a gateway to broader European adoption, especially with Zimmer Biomet's clout driving sales in high-value markets. Osteopore's tech is simple but brilliant in a world where traditional implants just needed a tech facelift. With Europe's custom implant market looking at explosive growth, this week's share price surge reflects what could lie ahead for the struggling biotech. CLEARVUE TECHNOLOGIES LTD (ASX: OSX) Up 93% (14c – 27c) Snagging our final Runners' spot and absolutely flying this week is green-tech company ClearVue Technologies , which says it is ready to roll out its full range of breakthrough solar façade products that promise to transform a glazed building into a solar photovoltaic array. The company recently underwent a management refresh and on Wednesday announced that its fully certified range of vacuum-integrated solar glazing products, including cladding and spandrels, was ready for order and immediate deployment in projects. The innovative company plays in the building-integrated photovoltaic (BIPV) sector, developing solar glazing that generates electricity while lowering energy usage and maintaining glass transparency for aesthetic building design. Its vacuum-insulated glazing (VIG) units, developed with LandGlass Technology's LandVac, integrate solar technology into windows and façades, targeting sustainable construction and net-zero buildings. Operating primarily in Australia with a focus on Asian markets such as Hong Kong, ClearVue's solutions meet stringent fire safety standards for high-rise and high-risk environments. The company has been turning heads this week, and saw its share price surge 93 per cent to a 27c close on Friday, after ClearVue released stellar results from a trial of its VIG units in the headquarters of Hong Kong's Electrical and Mechanical Services Department. The trial showed a 4.6-year payback period (2.6 years with subsidies) and the potential to offset 74-125 per cent of a 40-storey building's energy needs. With certifications in place and a new Hong Kong subsidiary plus an R&D joint venture with LandVac, investors piled in to bet on ClearVue's ability to capitalise on Asia's sustainable building boom. The company says its technology is a perfect fit for urban centres racing toward net-zero carbon goals, especially in Asia where high-rise construction is booming. With its Hong Kong trial success, coupled with a U-value of 0.58 – trouncing standard windows – ClearVue is well positioned as a leader in energy-efficient building design. With Hong Kong's government endorsement and plans for further R&D, the company is poised to turn skyscrapers into power plants, making this week's share price jump a tantalising hint of the green revolution ClearVue could unleash globally. Is your ASX-listed company doing something interesting? Contact:
News.com.au
16-07-2025
- Business
- News.com.au
Why $487 million US distribution deal is a ‘watershed moment' for skyrocketing biotech Lumos
Lumos signs six-year exclusive deal valued at up to US$317 million with PHASE Scientific for distribution of FebriDX in US subject to CLIA waiver US$2 million payable immediately, comprising US$1 million exclusivity fee and US$1 million pre-paid purchase order Further US$1.5 million pre-paid purchase order will become payable on FebriDx CLIA waiver application to US FDA, expected within three months Lumos Diagnostics (ASX:LDX) has skyrocketed more than 150% after inking a landmark six-year distributor deal worth hundreds of millions of dollars to sell its rapid point-of-care diagnostic in the US market. The FebriDx product is a simple test able to differentiate between bacterial and non-bacterial acute respiratory infections. A lucrative US licencing deal with Hong-Kong based PHASE Scientific could see Lumos net up to to US$317m (~A$487m), and has been described as one of the largest distribution deals of its type to be done by an ASX-listed point-of-care diagnostics company. It's all positive for investors including Tenmile, a wholly-owned subsidiary of billionaire backers Andrew 'Twiggy' and Nicole Forest's private investment vehicle Tattarang. Tenmile is the largest shareholder of Lumos, holding 19.9% of the stock. PHASE backs cutting-edge test The deal assigns exclusive distribution rights to PHASE for the point-of-care blood test, which helps clinicians differentiate between a bacterial or viral respiratory infection within about 10 minutes. The agreement includes a US$1 million non-refundable exclusivity payment upon signing, along with an additional US$7.5m in non-refundable prepaid purchase orders, payable in three instalments including: US$1m upon signing of agreement US$1.5m upon submission of the FebriDx CLIA waiver application to the US Food and Drug Administration (FDA); and US$5m on granting of the US FDA CLIA waiver. Assuming PHASE achieves all payment milestones outlined and meets minimum order quantities, which are expected to "progressively ramp up", Lumos forecasts total value of the agreement reaching up to US$317m (~A$487m) over its six year duration. Lumos is currently undertaking a CLIA waiver study in the US to enable FebriDx to be used in a broader range of healthcare settings, including physician offices that do not operate under high-complexity laboratory certification. As of July 9, the study had enrolled 105 bacterial positive patients of the targeted 120 bacterial positive patient results required for the study. At the current accrual rate, the study is forecast to be completed during August with an FDA CLIA waiver application submitted about one month after completion. 'Watershed moment' Speaking with Stockhead from the US, Lumos managing director Doug Ward described the deal as transformational financially for the company, which listed on the ASX in July 2021. "I think this is a watershed moment for the business going forward," he said. "It will take hard work to realise everything but at the same time we have put ourselves in a great trajectory here to be very successful." As Lumos edges closer to wrapping up the CLIA waiver study, it has been quite the belle of the ball, attracting several suitors for its FebriDX distribution rights. "We selected PHASE for several reasons including they have a great understanding and experience in the US point-of-care market," Ward said. "While Hong Kong-based the majority of their sales are US based, and they know this point of care market very well." Ward said launching a brand-new product into the US market takes knowledge and experience of the landscape, but also financial commitment. "PHASE have made it clear of their intention to invest, and they just did a significant funding round in Hong Kong so have the means and commitment to make this happen," he said. "We also wanted to go with a company where we knew we were their primary focus so there were other companies which had more products in their bag, but we didn't want to be one of 50 or 100." Instead, Ward said he wanted to be one of small number of synergistic products for a distributor. "I think that hunger and focus is there, and PHASE should be very successful," he said. Non-executive chairman Sam Lanyon also praised PHASE and said he was confident the company would be a motivated partner to push the commercialisation of FebriDX in the US. Tapping into lucrative market opportunity Ward said in the US, point-of-care testing for respiratory illnesses like influenza and covid-19 represented a market worth more than US$1 billion, with strong demand for fast, accurate diagnostics in primary care and outpatient settings. "If you have a respiratory element to your sickness here in the US, you'll be immediately tested for covid or flu and we see FebriDX sitting side by side with those point-of care tests," Ward said. "The doctor can determine whether their patient does or doesn't have covid or flu and then whether their patient has a bacterial infection and needs antibiotics. "So, we don't need to teach doctors what we call a new care pathway but rather get them to be aware they can add FebriDX to their testing arsenal to assist with patient treatment." Lumos is tackling antimicrobial resistance (AMR) – the ability of microbes to resist the effects of medication – with FebriDX, which according to the World Health Organization is one of the top global public health threats. Ward said a significant contributor to the AMR crisis was the inappropriate prescribing of antibiotics, particularly for acute respiratory infections in primary care settings. "Our mission is to impact and improve the practice of medicine and we think FebriDX does that so we're very excited," he said. "It is something which is fresh, novel and should really improve care." Positioned to bring FebriDX to frontlines of care PHASE Scientific founder and CEO Dr Ricky Chiu said the company was proud to partner with Lumos as their exclusive US distributor for FebriDx, and to welcome the test into its INDICAID family, its trusted rapid diagnostics brand known for accessibility and quality. "With strong product differentiation and a CLIA waiver on the horizon, FebriDX is poised to transform the landscape of rapid respiratory diagnostics and clinical decision-making," Chiu said. "Backed by PHASE's record of having sold over 100 million INDICAID tests and a nationwide network of urgent care centres and clinics, we're uniquely positioned to bring this innovation to the frontlines of care — where speed, accuracy, and reliability matter most." At Stockhead, we tell it like it is. While Lumos Diagnostics is a Stockhead advertiser, it did not sponsor this article.
Herald Sun
18-06-2025
- Business
- Herald Sun
StockTake: Lumos Diagnostics
Stockhead's Tylah Tully unpacks the latest from Lumos Diagnostics (ASX:LDX), who have enrolled its 500th patient in a CLIA waiver study for FebriDx, its rapid point-of-care diagnostic test to differentiate between bacterial and non-bacterial acute respiratory infections. The company has a funding partnership with the US government's Biomedical Advanced Research and Development Authority (BARDA). Lumos has now received more than US$1.2 million in milestone payments from BARDA, which has pledged nearly US$3 million toward the study. Watch the video to learn more. This video was developed in collaboration with Lumos Diagnostics, a Stockhead advertiser at the time of publishing. This video does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as StockTake: Lumos enrols 500th patient in crucial respiratory diagnostic test study
Herald Sun
03-06-2025
- 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.
