Latest news with #LumosDiagnostics
News.com.au
21-07-2025
- Business
- News.com.au
Health Check: On Lamington Day, biotechs serve up their chocolate-dipped quarterly morsels
Today's news is all sweet on trial progress, revenue and cash Amplia to raise capital after runaway share performance Tryptamine starts binge eating 'magic mushie' trial Today is National Lamington Day and biotechs are serving up a solid sponge-like base of news encased in chocolate and coconut – occasionally interspersed with a jam layer. Hold the cream and pink jelly though – it just doesn't work. Like so many drug discoveries, the lamington had serendipitous origins. The story goes that one of Queensland governor Lord Lamington's maids was serving up a yellow sponge, but accidentally dunked it into molten chocolate. Lord Lammo recommended the squares to be rolled into coconut shavings for ease of eating – and the rest is history. As is this non-sequitur. Now onto the biotech news. Lumos glows after last week's mega deal Point-of-care diagnostics house Lumos Diagnostics (ASX:LDX) reports revenue of $12.4 million for the year to June 30, up 12%. June quarter revenue declined 26% to $2.6 million, owing to the end of the US flu season. Lumos reported cash outflows of US$1.7 million for the quarter, taking June 30 cash to US$2 million. Investor interest has focused on last week's mega US distribution deal with Phase Scientific, which could deliver Lumos up to US$317 million ( $487 million) over six years. This pertains to the company's bacterial-versus-viral rapid lateral flow test, Febridx. Lumos has also signed a term sheet for a $5 million loan facility, proffered by shareholders Tenmile Ventures (Andrew Forrest) and Ryder Capital. At its discretion, Lumos can draw down the facility over the next 12 months. Cleo eyes FDA approval for ovarian cancer assay Still on diagnostics, Cleo Diagnostics (ASX:COV) says it aims to submit a US Food & Drug Administration (FDA) marketing approval application for its ovarian cancer assay next year. The company is on track to complete a supportive US trial in the December quarter. Thanks to government grants and tax incentives, Cleo reported cash inflows of $38,000, taking end of quarter cash to $6.46 million. Turning to drug development, genetic disease specialist PYC Therapeutics (ASX:PYC) reports cash outflows of $17.6 million. At quarter's end the company still had cash of $153 million. The company has dosed the first patient in a combined phase 1a/2b trial for polycystic kidney disease. PYC has achieved 'alignment' with the FDA on the structure of a registrational trial for its lead program, the blinding eye disease retinitis pigmentosa type 11. The company believes the regulator will require only a phase II trial. Tryptamine BEDS down eating disorder trial Psychedelic medicines house Tryptamine Therapeutics (ASX:TYP) has started recruiting patients for a world-first binge eating disorder (BED) study. In the open-label trial, 12 patients will be administered intravenously infused psilocybin, combined with psychotherapy. Melbourne's Swinburne University is undertaking the study, with first dosing this quarter and top line results due by the end of the year. BED is the most common eating disorder in the US and second most prevalent in Australia here. The condition can result in depression, anxiety, post-traumatic stress disorder and compulsive behaviour. Amplia passes the hat Meanwhile Amplia (ASX:ATX) shares this morning entered trading halt, ahead of a share placement and share purchase plan. Amplia thus continues the rich tradition of companies leveraging clinical trial results, in this case its stunning data for hard-to-treat pancreatic disease. Amplia has reported 17 'partial response' rates in it Accent trial, in 17 out of 55 advanced disease patients. A confirmed partial response is tumour shrinkage of more than 30%, sustained for two or more months with no new cancerous lesions detected. Amplia is testing AMP-945 (narmafotinib). AMP-945 appears to inhibit the protein FAK, which is overexpressed in pancreatic cancers. Amplia shares have surged 376% in the past 12 months, but investors still value the company at a modest $110 million. As of the end of March, Amplia had cash of $10.8 million. 'Perplexed' Imugene laments soft-as-a-sponge share price Imugene (ASX:IMU) chairman Paul Hopper hopes the company's lamington-soft share price will 'do an Amplia' (our words) and reflect the company's progress with its multiple cancer trials. The company last Monday announced its phase 1b study for an aggressive blood cancer had resulted in two additional 'complete responses' (that is, the tumours disappeared). Imugene is trialing Azer-cel, its allogeneic Car-T drug made from healthy donor T-cells rather than the patient's. Naturally, Imugene announced a $22.5 million and share purchase plan for up to $15 million. On reinstatement, the shares lost 4.5 cents, or 10%, taking the loss over the past year to around 80%. This allows for a one for 34 share consolidation. 'We are very disappointed with the share price performance,' Hopper says. 'We are perplexed why we had such a lukewarm reception to the earlier data at the start of year.' Cashed up for pivotal trial But with the share raising in train, Imugene investors should no longer fear that such a dilutionary event is around the corner. Post raising Imugene should have cash of $64 million, with management costing a 60-80 patient pivotal trial at $30-40 million. If approved, Azer-cel would be the first commercial allogenic Car-T treatment, enabling mass produced, off-the-shelf therapies. 'We are in active discussions with partners on the strategy for developing the drug and getting it approved,' Hopper says. Shares settle in orbit after last week's Meso-blast off Mesoblast (ASX:MSB) shares have taken a breather after Friday's 35% surge on the back of initial US sales of its first US-approved stem cell product. The company reported unaudited June quarter revenue of US$13.2 million ($20.3 million) for Ryoncil, its treatment for childhood graft-versus-host disease. The FDA approved Ryoncil in December last year. Mesoblast founder and CEO Prof Silviu Itescu points to higher sales in the current quarter, given US Centres for Medicare and Medicaid Services coverage became effective on July 1. The company has signed up more than 25 transplant centres and hopes to enlist all 45 priority centres by October. Bell Potter analyst John Hester says the sales were in line with the firm's expectations. 'The figure is inclusive of sales to the distributor, nevertheless it represents a reasonable proxy for hospital demand.' The firm values Mesoblast at $3.50 a share, implying 55% of upside.
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
16-07-2025
- Business
- Yahoo
PHASE Scientific Expands INDICAID® Respiratory Portfolio with Exclusive U.S. Launch of Novel FebriDx® Test
FebriDx® is a first-in-class rapid test that differentiates between bacterial and non-bacterial respiratory infections, offering significant potential to address critical unmet needs in patient care by enabling more informed antibiotic use and aiding in the reduction of antimicrobial resistance. Introduction of FebriDx will enhance PHASE Scientific's INDICAID® portfolio and strengthen its leadership in point-of-care respiratory diagnostics. Partnership underscores PHASE Scientific's proven commercial execution in the U.S. market with its extensive nationwide clinical network, building upon its strengths in R&D innovation. GARDEN GROVE, Calif., July 15, 2025 /PRNewswire/ -- PHASE Scientific, a fast-growing biotech company known for its science-driven innovation and commitment to improving healthcare outcomes, today announced that it has entered into an exclusive U.S. distribution agreement with Lumos Diagnostics for FebriDx®, a rapid point-of-care (POC) test that aids in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial etiology in approximately 10 minutes using a single drop of blood. With strong product differentiation, FDA 510(k) clearance, and an anticipated CLIA waiver application within the next three months, FebriDx® is poised to transform how clinicians diagnose and manage respiratory infection. FebriDx® will become part of PHASE Scientific's INDICAID® portfolio – a trusted brand for high-quality, accessible rapid diagnostics. The partnership marks a significant milestone in PHASE's commercial expansion in the United States, building upon a nationwide network of urgent care centers, clinics, and healthcare providers and a proven track record of distributing over 100 million INDICAID® tests. "We are thrilled to partner with Lumos, a company that shares our commitment to shaping the future of healthcare through innovation and collaboration, and support them with our scalable go-to-market strength in North America," said Dr. Ricky Chiu, Founder and CEO of PHASE Scientific. "A powerful complement to our INDICAID® respiratory portfolio, FebriDx® is a first-in-class diagnostic that perfectly aligns with our mission to bring fast, actionable diagnostics to the frontlines of care. We are confident this will unlock synergistic opportunities, further advancing our impact on antimicrobial stewardship and clinical decision-making across the U.S. As we continue to expand the INDICAID® brand, we remain dedicated to strengthening our leadership in point-of-care solutions, empowering clinicians, and improving access to high-quality healthcare." Doug Ward, CEO of Lumos Diagnostics, commented, "This distribution agreement reflects a pivotal moment in Lumos' evolution. We look forward to working with the PHASE Scientific team to ensure that FebriDx® secures adoption in the U.S. market, delivering tangible clinical and financial value to the broader healthcare system. This agreement also validates the value of the FebriDx® technology and provides a clear pathway to the U.S. market, which we expect will accelerate rapidly should we receive a grant for CLIA waiver from the FDA. Transforming Respiratory Infection Diagnosis FebriDx® fills this diagnostic gap with a rapid, point-of-care test that uses a unique combination of C-reactive protein (CRP) and Myxovirus resistance protein A (MxA) biomarkers to aid in the diagnosis of bacterial from non-bacterial respiratory infections after 10 minutes. Its lateral flow format requires only a fingerstick blood sample and has been validated in a pivotal clinical study and demonstrated good diagnostic performance that can, in turn, improve diagnostic confidence and antibiotic stewardship decisions. By enabling faster, more informed treatment decisions, FebriDx® supports more targeted care in busy patient settings – currently including urgent and emergency care. A CLIA waiver study is progressing well, with anticipated study completion and application submission expected within the next three months. This would expand access to FebriDx® across a broader range of outpatient environments, representing a market opportunity of approximately US$1.5 billion. Driving Antimicrobial Stewardship FebriDx® plays a critical role in aiding in addressing the global threat of antimicrobial resistance (AMR), which continues to strain public health systems and drive avoidable costs. By providing rapid, actionable results at the point of care, FebriDx® helps reduce unnecessary antibiotic prescribing – a key contributor to AMR – and improves clinical workflows by supporting more accurate triage and treatment. Clinical studies have demonstrated that integrating FebriDx® can lead to reduced antibiotic use, lower healthcare costs, and better patient outcomes. Its unique ability to guide appropriate prescribing makes it a valuable tool in everyday patient care. Strengthening U.S. Market Presence This agreement represents a major step in PHASE Scientific's strategy to reinforce its dual strengths in R&D innovation and commercial execution, as well as accelerate its leadership in the U.S. diagnostics market. Known for its proprietary PHASIFY™ technology and innovation pipeline in cancer and infectious disease diagnostics, PHASE Scientific is now demonstrating its scalable go-to-market strength in North America. About PHASE Scientific PHASE Scientific International Limited ("PHASE Scientific") is a fast-growing biotech company with a mission to inspire a new state of health through innovative diagnostics and healthcare solutions. With operations in the U.S., mainland China, and Hong Kong SAR, PHASE delivers novel diagnostic tools and services for cancer and infectious diseases using proprietary technologies, empowering better disease detection, diagnosis, and management. PHASE Scientific's products and services have received certifications from the U.S. Food and Drug Administration (FDA), the European Union CE, and regulatory agencies in various countries, providing over 100 million testing products and services in more than 30 countries worldwide. PHASE Scientific has recently completed a US$34 million Series A funding round, representing the largest Series A raise in Asia's diagnostic technology sector since 2019. Other supporters include Gates Foundation, and US governmental agencies National Science Foundation and National Institutes of Health. For more information, please visit About FebriDx® FebriDx® is a unique, rapid point of care test that helps clinicians differentiate between bacterial and non-bacterial acute respiratory infections through a simple fingerstick blood sample after 10 minutes. By aiding clinicians make faster, better decisions at the point-of-care, FebriDx® has the potential to improve patient outcomes, reduce unnecessary antibiotic prescriptions, and lower overall healthcare costs – all while addressing the urgent global challenge of antimicrobial resistance (AMR). About Lumos Diagnostics Lumos Diagnostics specializes in rapid and complete point-of-care diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions. Lumos offers customized assay development and manufacturing services for point-of-care tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercializes novel Lumos-branded point-of-care tests that target infectious and inflammatory diseases. For more information visit Media Contact PHASE Scientificpr@ FGS GlobalPhaseSci@ View original content to download multimedia: SOURCE PHASE Scientific
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
