Lumos Diagnostics

Lumos has commenced its FebriDx® CLIA-waiver pediatric study in the United States, with the first patient successfully enrolled.    The study will assess the use of the FebriDx device in children aged 2 to 12 years within CLIA-waived settings. It will be conducted across 20 clinical sites in the US. Between 500 and 800 patients are expected to be enrolled to achieve the required number of bacterial cases. The study is expected to run for approximately 12 months, following which a formal submission will be prepared for the FDA.    A successful outcome will support the expansion of FebriDx’s use as a diagnostic tool for differentiating bacterial from non-bacterial acute respiratory infections in the US, broadening its patient usage from ages 12 - 64 to 2 - 64 years.    Doug Ward, CEO of Lumos Diagnostics, said:   “The commencement of this study marks an important milestone for FebriDx and our commitment to aiding healthcare professionals in improving infection diagnosis in children. A successful outcome would represent a significant step forward in helping healthcare professionals quickly and confidently differentiate bacterial and non-bacterial acute respiratory infections in children aged 2 to 12 years, supporting better treatment decisions and antibiotic stewardship.”    🔗 Read the ASX release: https://bit.ly/47gQgJo    $LDX #LDX #Lumos #diagnostics #pointofcare #respiratoryhealth #healthcare #rapidtest 

🖋️ New Agreement   Lumos Diagnostics has today announced that it has entered into agreement with WellStreet Urgent Care to advance testing and reimbursement for FebriDx® through WellStreet’s joint venture with Piedmont Healthcare in Atlanta, Georgia.     FebriDx testing will occur at a Piedmont Urgent Care location handling approximately 50 patients per day presenting with respiratory infections, providing volume and operational insight.     WellStreet will procure the FebriDx® test through PHASE Scientific. Pro-spectus will oversee data management and reimbursement outcomes. Lumos CEO Doug Ward said:     “We are excited to partner with WellStreet to bring FebriDx® into a high-throughput, clinically integrated setting. This agreement will greatly assist in laying the groundwork for a scalable national roll-out, pending CLIA waiver. We also greatly value the role of PHASE Scientific and Pro-spectus in aiding in the rollout of this program.”    The program is expected to commence in October 2025.    Read the ASX release 👉 https://bit.ly/4hjdq6I     $LDX #LDX #Lumos #pointofcare #rapidtest #diagnostics #FebriDX 

Lumos Diagnostics is pleased to participate in the AMMA Medtech Showcase 2025, following our completion of MTPConnect’s Pathway to Market – Medtech Capability Uplift Program. This initiative has provided invaluable opportunities to strengthen our Austalian commercial channel and connect with health system leaders, manufacturers and clinicians committed to advancing Australian medical technologies. We’ll be at the Showcase this Thursday 16 October at PARKROYAL Monash Melbourne, where we’ll be highlighting FebriDx® - our clinically validated rapid test that supports more informed and timely diagnostic decisions for patients with acute respiratory infections. If you’re attending, visit our booth to meet the Lumos team and learn more about how FebriDx can support better, faster diagnostic decisions in primary and acute settings. Register here 👉 https://bit.ly/3JaP2aA $LDX #LDX #Lumos #diagnostics #AMMA #MedtechShowcase #AustralianManufacturing #BetterHealthMadeHere #HealthProcurement MTPConnect BioMelbourne Network Amelia Vom Sarah King-Smith

Independent research firm Sandstone Insights recently released a new report on Lumos, noting that Lumos’ successful clinical study and CLIA waiver submission have the potential to significantly expand our US market opportunity.     “Lumos Diagnostics has completed its clinical study and submitted a CLIA waiver application to the US FDA for its FebriDx test. This test showed over 98% concordance between trained and untrained operators, highlighting its simplicity and ease of use. Approval could significantly expand its market opportunity in the US.”    The report assigns Lumos a valuation of A$0.22 per share, reflecting confidence in our near-term growth opportunities and the commercial potential of FebriDx®.    Read the full report 👉 https://bit.ly/4oeEruj   $LDX #LDX #Lumos #pointofcare #diagnostics #invest 

Last week, Lumos’ CFO Barrie Lambert spoke with Fouad Haidar at Proactive to discuss the Company’s near-term priorities.     In this interview, he discusses Lumos’ upcoming paediatric study designed to expand FebriDx® access to younger patients, our recent CLIA waiver submission which, if approved, will open access to more than 270,000 clinics and 80 million annual patient visits in the United States, and our ongoing collaboration with Hologic, one of the world’s leading diagnostic companies.    Take a look: https://lnkd.in/euzZ26vP     $LDX #LDX #Lumos #pointofcare #diagnostics #invest  

New real-world data measuring the use of FebriDx® in GP practices, urgent care settings and acute respiratory infection hubs has shown a compelling reduction in antibiotic prescribing, improved patient experience, cost savings and more. These insights were shared in a poster - “Evaluating a rapid viral vs bacterial point of care test (CRP + MxA) to support diagnosis and appropriate antibiotic prescribing in Calderdale, West Yorkshire ICB” - presented at the Primary Care Respiratory Society (PCRS) Annual Conference in Telford, England. It was awarded the Most Patient Centred Poster by the PCRS patient reference group too. Lumos SVP of Commercial Operations, Paul Kase, said: "This paper underscores what we’ve seen on the ground: when given rapid, reliable, viral versus bacterial confirmation, clinicians are more confident in their decisions. This drives patient benefit and health system savings. We’re grateful to Muzammel, the Calderdale team and all those involved in reporting these important findings." Learn more here: https://lnkd.in/g_6_vDeh #LDX #Lumos #diagnostics #pointofcare #healthcare #innovation

Lumos Diagnostics was proudly showcased in the ASX SMIDcaps Conference in Sydney today - alongside ASX-listed small and mid-cap company peers and a vast network of investors. Lumos CFO Barrie Lambert shared compelling Company highlights: ⭐ First in Class Product FebriDx® Nearing Major US Breakthrough ⭐ > US$1.0 Billion p.a. TAM for FebriDx®  ⭐ US$317M (A$487M) Distribution Deal with Phase Scientific ⭐ Revenue Growth and Margin Strength ⭐ Strong Funding Partnerships, No Debt, No Royalties Payable ... and much more. Interested to learn more about investing in Lumos Diagnostics (ASX:LDX)? Visit our investor centre: https://bit.ly/ASXSMIDCaps $LDX #ASX #Diagnostics #Invest

Lumos Diagnostics has signed a new distribution agreement with Amtech, part of the YesGroup alliance, to expand access to its flagship rapid diagnostic test, FebriDx®, across Australia and New Zealand. YesGroup is a major Australasian medical and safety supplies alliance, that brings together two trusted brands, Yes Medical, and Amtech Medical. YesGroup employs over 150 team members and offers a portfolio with more than 25,000 product lines across multiple brands. Doug Ward, CEO of Lumos Diagnostics said: “We are delighted to expand FebriDx® distribution in Australia and New Zealand through this new partnership with YesGroup. With their reach and long-standing presence in the local healthcare market, alongside our existing agreement with Henry Schein, we are well positioned to make FebriDx® more widely accessible to clinicians.” Read the ASX release 👉 https://lnkd.in/eWRG-HDy $LDX #LDX #Lumos #pointofcare #diagnostics #rapidtest #healthcare #innovation

Lumos Diagnostics has secured a follow-on contract with Aptatek Biosciences to advance the PheCheck™ in-home monitoring device for phenylketonuria (PKU). Valued at US$1.5 million, the engagement will progress PheCheck™ through formal verification and validation studies, moving it closer to clinical trials and regulatory submission. PKU is a rare inherited disorder affecting around 1 in 12,000 newborns, and Lumos is proud to support Aptatek in developing an at-home monitoring solution that has the potential to transform disease management for patients and families Apatek Biosciences CEO, Michael Boyce-Jacino said:  “We are delighted to have selected Lumos once again as our partner in bringing the PheCheck aptamer-based in-home monitoring platform to market. PKU is a challenging condition for patients and families, and a reliable at-home monitoring tool has the potential to transform how it is managed.” Read the ASX release 👉 https://bit.ly/LDX_Aptatek $LDX #LDX #Lumos #diagnostics #pointofcare #healthcare #innovation

Lumos Diagnostics has announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded US$6.2 million in non-dilutive funding to support a new U.S. paediatric study of our flagship FebriDx® test. This study will evaluate the use of FebriDx® in children aged 2–12 years across CLIA-waived settings. Commencing in Q3 CY2025, it will form the basis of a dual 510(k)/CLIA waiver submission.  If granted, CLIA waiver expansion could increase our U.S. total addressable market more than fifteen-fold to over US$1 billion, providing access to 270,000 clinical sites and covering 80 million annual acute respiratory consultations Lumos Diagnostics CEO Doug Ward said:   “We greatly appreciate BARDA’s continued support—both in the recently completed CLIA waiver study and now in advancing this important paediatric study. We look forward to working closely with BARDA once again to deliver this study and further expand the accessibility of FebriDx® to paediatric patients across the United States.” Read the ASX release 👉 https://lnkd.in/g3ZgecBH $LDX #LDX #Lumos #diagnostics #pointofcare #paediatrics #healthcare #innovation