Latest news with #pointofcare
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.
News.com.au
16-07-2025
- Business
- News.com.au
Health Check: Lumos shares 150pc brighter after company-making US diagnostics deal
Lumos Diagnostics says its US distribution deal is worth up to $487 million Impedimed's US device sales are on a roll Noxopharm treats its first lupus trial patient In one of the 'largest distribution deals of its type' by an ASX-listed point-of-care diagnostics company, minnow Lumos Diagnostics (ASX:LDX) has inked a US compact worth up to US$317 million ($487 million) over six years. The agreement is with the Hong Kong-based Phase Scientific and relates to Lumos's lateral-flow assay, Febridx. With a finger prick blood sample, Febridx enables clinicians to differentiate between bacterial and non-bacterial acute respiratory infections in around 10 minutes. Lumos expects to sell Febridx under a mechanism called the 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. Dissecting the deal As is always the case with such deals, the up-front amount is modest: US$2 million by way of a US$1 million exclusivity fee and a US$1 million pre-paid purchase order. Phase Scientific pays a further US$1.5 million from a further purchase order when Lumos lodges the CLIA waiver application. Investors should expect this within three months. There's then a further US$5 million pre-paid order if Lumos achieves the exemption. Between the second and sixth years, Phase's minimum order quantities gradually ramp up – and that's where the US$317 million comes into the picture. Put in context, Lumos was valued at a little over $20 million before this morning's 150% romp – handy pocket money for billionaire backers Andrew and Nicola Forrest, who hold 19.9% of LDX's stock. 'This agreement validates the value of the Febridx technology and provides a clear pathway to the US market, which we expect will accelerate rapidly,' says Lumos CEO Doug Ward. To support the requisite CLIA waiver application, Lumos is carrying out a supportive study which has enrolled 105 of the targeted 120 bacterial positive patients. Stretched US hospital funding is no impediment to Impedimed The US also is proving fertile ground for ImpediMed (ASX:IPD), with sales doubling in the June quarter. The maker of a lymphodema detection device called Sozo, Impedimed sold 44 units in the US in the quarter, compared with 22 in the March quarter. This included a nine-unit contract with Legacy Health, which has six hospitals and 70 primary care facilities across the east coast. Renewals during the quarter took total contract value (new and renewed contracts) to a record $6.3 million, 29% higher than the March stanza. 'Over the last year, Impedimed has seen a significant increase in leads and opportunities resulting from the initiatives implemented under the new leadership team,' the company says. Management expects a current level of sales in the current quarter, 'with improvement in subsequent quarters as the pipeline matures and additional internal initiatives take effect.' Lymphodema is swelling of the limbs, typically the arms and legs, usually caused by cancer treatments. Before Sozo came along, the condition was appraised with a tape measure. The sales uptick qualifies Impedimed for an additional US$5 million under a US$15 million debt facility, with specialist lender SWK Funding. Impedimed plans to release its quarterly numbers on July 31. Imugene targets $37.5 million equity raising Immuno-oncology play Imugene (ASX:IMU) has raised $22.5 million in an institutional placement and hopes for another $15 million by way of a share purchase plan. The whip 'round follows Monday's revelation of further strong clinical results from the company's phase 1b trial of its blood cancer therapy, Azer-cel. The funds will support a planned US pivotal trial. The company did the deal at 33 cents, a 22% discount to Monday's frozen price. Subscribers receive a free option on a three-for-four basis, exercisable at 43 cents after March next year. On exercise of those options, investors receive one-for-one piggyback oppies, exercisable at 86 cents. The raising takes Imugene's cash kitty to $64 million. Noxopharm hopes that HERACLES will slay lupus Noxopharm (ASX:NOX) has dosed the first patient in its first-in-human trial of its drug candidate for the painful autoimmune disease lupus. Dubbed HERACLES, the dose escalation study aims to evaluate the safety and tolerability profile of its candidate, SOF-SKN. Lupus affects about five million people globally – 90% of them women. The HERACLES trial targets cutaneous lupus erythematosus (CLE), the most common form. This is when body's immune system mistakenly attacks skin cells, causing inflammation and skin lesions and sores. SOF-SKN modulates inflammation at its source. 'The global lupus market is worth more than US$3 billion and is expected to grow significantly over the coming years,' Noxopharm CEO Dr Gisela Mautner says. SOF-SKN is an exponent of the company's core tech Sofra, acquired from the Hudson Institute of Medical Research. Noxopharm hopes to apply the core Sofra tech to rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease and dementia (which also is immune related). HERACLES stands for 'harnessing endogenous regulation against CLE study'. Heracles was famed in Greek mythology for his immense strength, courage and ability to slay monsters. Along with a bucket of money, these are all prerequisites for drug development. August 1 D-day for Trump tariff drug slug? It's hard to distinguish Donald Trump's genuine intentions from his brain farts, but it looks like the global pharma sector should expect some movement on his threatened pharma tariff by August 1. Trump told reporters that along with a tariff on semiconductors, he should announce the drug impost 'probably at the end of the month'. 'We're going to start off with a low tariff and give the pharmaceutical companies a year or so to build, and then we're going to make it a very high tariff,' the Prez said. Drug makers can avoid the tariff – mooted to be up to 200% – by moving drug manufacturing to US shores. As reported, CSL is the most likely ASX drug stock in the firing line. But given the maker of plasma derived therapeutics draws on US blood donors and has some US manufacturing, the repercussions are as clear as Trump's Ukraine peace plan.
Yahoo
17-06-2025
- Business
- Yahoo
Middle East & Africa Point-of-Care Diagnostics Market Analysis Report 2025-2032 - Telemedicine and POC Convergence Unlock New Opportunities
The Middle East and Africa point-of-care diagnostics market is set for transformative growth, driven by rising demand for rapid and accurate diagnostic solutions. Valued at US$ 3.18 billion in 2025, it's projected to reach US$ 6.9 billion by 2032 with a CAGR of 11.67%. Modernization of healthcare systems, increasing investments in rural areas, and technological advancements such as AI integration propel this growth, with Saudi Arabia and UAE leading. Despite challenges like limited healthcare spending in some regions, initiatives in telemedicine and AI-based solutions offer significant opportunities. Notable market players include QIAGEN, Danaher, and Abbott. Dublin, June 17, 2025 (GLOBE NEWSWIRE) -- The "Middle East & Africa Point-of-Care Diagnostics Market - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2032 - By Product, Technology, Grade, Application, End-user, Region: (Middle East & Africa)" report has been added to Middle East and Africa (MEA) point-of-care diagnostics market is undergoing a significant transformation, driven by increasing demand for rapid, accessible, and reliable diagnostic solutions. As healthcare systems across the region continue to modernize, the market is expected to grow from an estimated US$ 3.18 billion in 2025 to US$ 6.9 billion by 2032, registering a robust compound annual growth rate (CAGR) of 11.67% during the forecast point-of-care (POC) diagnostics market in MEA is gaining traction, supported by growing awareness of early disease detection, rising healthcare spending in key nations, and the integration of innovative technologies. Countries like Saudi Arabia and the United Arab Emirates are at the forefront of this growth, with government initiatives driving the adoption of modern healthcare technologies, including POC limited access to centralized diagnostic laboratories and high healthcare costs posed challenges to market expansion. However, recent advancements in portable diagnostic devices, along with rising healthcare awareness and increased mobile health adoption, have enabled POC solutions to become more widespread, especially in underserved and remote Market DriversPrevalence of Infectious and Chronic DiseasesThe MEA region continues to grapple with a high burden of infectious diseases like HIV, tuberculosis, and influenza, along with a sharp increase in non-communicable diseases such as diabetes and cardiovascular conditions. POC diagnostics have emerged as a vital tool in enabling timely and accurate diagnosis, helping healthcare providers address these challenges more for Rapid and Accurate Diagnostic ToolsThe increasing need for fast diagnostic results, especially in rural and resource-constrained environments, is fueling the adoption of POC technologies. These tools help in faster decision-making, efficient patient management, and improved treatment outcomes, especially during health emergencies and disease Digitalization and AI IntegrationTechnological advancements, including the use of artificial intelligence (AI) and machine learning in diagnostics, are enhancing the accuracy and speed of POC testing. These innovations allow for real-time data analysis and personalized diagnostic support, making diagnostics more precise and OpportunitiesTelemedicine and Mobile Health ExpansionThe convergence of POC diagnostics with telemedicine and mobile health applications is creating new avenues for growth. With the widespread use of smartphones and internet connectivity across MEA, healthcare delivery is becoming increasingly digitized, allowing patients in remote areas to access timely diagnostic services without visiting a in Rural and Underserved RegionsGovernments and non-governmental organizations are actively investing in healthcare infrastructure across rural regions. POC diagnostics are particularly beneficial in these areas, eliminating the need for long-distance travel to centralized labs and ensuring faster treatment initiation. These investments are likely to further unlock the market's growth of AI-Based POC SolutionsAI-powered diagnostic tools are revolutionizing how diseases are detected and managed at the point of care. Their integration with wearable devices and mobile platforms will enable real-time monitoring and predictive analytics, enhancing the overall value proposition of POC diagnostics. Market RestraintsDespite the promising growth outlook, the MEA point-of-care diagnostics market faces certain challenges. Limited healthcare spending in some African nations restricts access to advanced diagnostic technologies. The high initial cost and maintenance requirements of POC devices further hinder their adoption. Additionally, insufficient reimbursement frameworks and lack of trained professionals remain concerns in achieving broader market AnalysisSaudi Arabia remains the dominant player in the Middle East and Africa point-of-care diagnostics market. The country's healthcare modernization efforts, supported by strategic government policies, are leading to an increased demand for rapid and efficient diagnostics. The UAE also demonstrates a strong growth trajectory, driven by rising healthcare awareness and private sector contrast, several regions within Africa are still hampered by low healthcare spending and limited access to diagnostic tools. However, the growing focus on universal healthcare and global support for improving healthcare systems in these regions are expected to catalyze growth in the long AnalysisThe competitive Analysis of the MEA point-of-care diagnostics market is marked by both global healthcare leaders and emerging regional players. Companies are increasingly focusing on strategic partnerships, mergers, and investments in innovative diagnostic technologies to expand their market players operating in the region include: QIAGEN Danaher Corporation F. Hoffmann-La Roche Ltd BD (Becton Dickinson) Abbott BIOMERIEUX Nova Biomedical Werfen Trividia Health, Inc. Siemens Healthcare Private Limited Market Segmentation By Product: Infectious Disease Glucose Monitoring Hepatitis C HIV Testing Sexually Transmitted Disease (STD) Influenza Respiratory Infection Tropical Disease Healthcare-Associated Infection (HAI) Pregnancy and Fertility Tumor/Cancer Marker Cardiometabolic Cholesterol Coagulation Hematology Urinalysis Other Infectious Diseases By Prescription Mode: Prescription-based Over-the-counter (OTC) By Type: Consumables and Kits Software and Services Devices Accessories By End User: Hospitals Ambulatory Care Settings Home Care Research Laboratories Others By Country: Kingdom of Saudi Arabia United Arab Emirates South Africa Rest of Gulf Cooperation Council Rest of Middle East and Africa For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Yahoo
14-06-2025
- Business
- Yahoo
Avricore Grants Options
VANCOUVER, British Columbia, June 14, 2025 (GLOBE NEWSWIRE) -- AVRICORE HEALTH INC. (TSXV: AVCR) (the "Company" or 'Avricore') today announces that the Company's board of directors has approved the granting of stock options (the 'Options') exercisable for a total of 4,100,000 common shares to its directors, officers, employees and consultants at an exercise price of CAD $0.05 per common share. All Options were granted pursuant to the Company's stock option plan and are subject to the terms of the applicable grant agreements and the requirements of the TSX Venture Exchange. The options shall vest quarterly commencing on the date of grant. The options expire 5 years from the date of the grant, subject to the optionees continuing to act as directors, officers, employees or consultants of the Company. About HealthTab™ HealthTab™ is a turnkey point-of-care testing solution that combines best-in-class point-of-care technologies with a secure, cloud-based platform for tackling pressing global health issues. With just a few drops of blood from a finger prick, the system generates lab-accurate results on the spot and data is reported in real time. The test menu includes up to 23 key biomarkers for screening and managing chronic diseases, such as diabetes and heart disease (e.g., HbA1c, Lipid Profile, eGFR). HealthTab™ has also recently added capabilities for bacterial and viral tests, such as strep and COVID-19. The HealthTab™ network model is unlike anything in pharmacy today. It gives knowledgeable and trusted pharmacists a greater role in primary care delivery, while empowering patients to take more control of their health. It also reduces costs and waiting times and provides many potential revenue streams including equipment leasing & consumables, direct access testing, disease prevention & management programs, sponsored health programs, decentralized clinical trials, real world data (RWD) sets, and third-party app integration through API. About Avricore Health Inc. Avricore Health Inc. (TSXV: AVCR) is a pharmacy service innovator focused on acquiring and developing early-stage technologies aimed at advancing pharmacy practice and patient care. Through its flagship offering HealthTab™, a wholly owned subsidiary, the Company's mission is to make actionable health information more accessible to everyone by creating the world's largest network of rapid testing devices in community pharmacies. Contact: Avricore Health Inc. Kiki Smith, CFO778-968-1176info@ Cautionary Note Regarding Forward-Looking Statements Information in this press release that involves Avricore Health's expectations, plans, intentions, or strategies regarding the future are forward-looking statements that are not facts and involve a number of risks and uncertainties. Avricore Health generally uses words such as "outlook," "will," "could," "would," "might," "remains," "to be," "plans," "believes," "may," "expects," "intends," "anticipates," "estimate," "future," "positioned," "potential," "project," "remain," "scheduled," "set to," "subject to," "upcoming," and similar expressions to help identify forward-looking statements. In this press release, forward-looking statements include statements regarding: the completion of the placement and the expected timing thereof and the Company's expected use of proceeds from the placement; the unique features that the HealthTab™ platform offers to pharmacists and patients. Forward-looking statements reflect the then-current expectations, beliefs, assumptions, estimates and forecasts of Avricore Health's management. The forward-looking statements in this press release are based upon information available to Avricore Health as of the date of this press release. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of Avricore Health and are subject to a few risks, uncertainties, and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations, including without limitation: failure to meet regulatory requirements; changes in the market; potential downturns in economic conditions; and other risk factors described in Avricore's public filings. These forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances, unless otherwise required to do so by law. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
