Lumos Diagnostics

Lumos Diagnostics is pleased to announce an agreement to expand the scope of work under its Development Agreement covering the new fetal fibronectin (fFN) test for leading women’s health company, Hologic, Inc. The expanded scope of work relates to Phase 3 of the Development Agreement, which focuses on delivery of the system prototype. This phase will now include incorporating additional hardware features into the proprietary reader technology, with an additional fee to Lumos of between US$0.6 – US$0.8 million. Lumos Diagnostics Managing Director, Doug Ward, said: "We are extremely pleased with the progress of the Hologic fFN project. Phase 2 of the project is progressing well and is expected to complete around April 2025, triggering the second of the Phase 2 milestone payments, worth US$0.3 million.[SD1]  In collaboration with the Hologic team, Phase 3 will now deliver a more feature rich product."   Read the ASX release 👉 https://lnkd.in/gnTvRu6b $LDX #LDX #Lumos #diagnostics #womenshealth #innovation

🗓️ Investor Briefing | Monday 3 March at 1pm AEDT Lumos Diagnostics (ASX:LDX) has this week released its half yearly report for FY25, highlighting solid revenue growth, and significant progress across a number of pivotal commercial and development milestones. Join Lumos CEO and MD, Doug Ward, and Chief Financial Officer, Barrie Lambert, for an online investor briefing at 1:00pm AEDT on Monday 3 March. They will share an overview of the results and recent progress milestones, followed by a Q+A session. Register to attend 👉 https://lnkd.in/gP56axBF $LDX #LDX #Lumos #pointofcare #diagnostics #innovation #healthcare #antimicrobialresistance #AMR #invest

📰 𝐒𝐭𝐨𝐜𝐤𝐡𝐞𝐚𝐝 A recent Stockhead article by Nadine McGrath has highlighted Lumos' successful approach to business growth by leveraging strategic partnerships that drive innovation in point-of-care diagnostics, enabling us to expand our manufacturing capabilities and advance our platform development. Here's an excerpt: "𝘊𝘩𝘪𝘦𝘧 𝘵𝘦𝘤𝘩𝘯𝘰𝘭𝘰𝘨𝘺 𝘰𝘧𝘧𝘪𝘤𝘦𝘳 𝘚𝘢𝘤𝘩𝘢 𝘋𝘰𝘱𝘩𝘦𝘪𝘥𝘦 𝘵𝘰𝘭𝘥 𝘚𝘵𝘰𝘤𝘬𝘩𝘦𝘢𝘥 𝘓𝘶𝘮𝘰𝘴 𝘢𝘭𝘴𝘰 𝘩𝘢𝘴 𝘢 𝘭𝘢𝘳𝘨𝘦 𝘴𝘦𝘳𝘷𝘪𝘤𝘦𝘴 𝘴𝘪𝘥𝘦, 𝘸𝘩𝘦𝘳𝘦 𝘪𝘵 𝘱𝘢𝘳𝘵𝘯𝘦𝘳𝘴 𝘸𝘪𝘵𝘩 𝘣𝘶𝘴𝘪𝘯𝘦𝘴𝘴𝘦𝘴 𝘰𝘧 𝘷𝘢𝘳𝘪𝘰𝘶𝘴 𝘴𝘪𝘻𝘦𝘴 𝘵𝘰 𝘭𝘦𝘷𝘦𝘳𝘢𝘨𝘦 𝘪𝘵𝘴 𝘪𝘯𝘵𝘦𝘭𝘭𝘦𝘤𝘵𝘶𝘢𝘭 𝘱𝘳𝘰𝘱𝘦𝘳𝘵𝘺, 𝘱𝘭𝘢𝘵𝘧𝘰𝘳𝘮𝘴 𝘢𝘯𝘥 𝘬𝘯𝘰𝘸-𝘩𝘰𝘸.  “𝘛𝘩𝘦 𝘣𝘶𝘴𝘪𝘯𝘦𝘴𝘴𝘦𝘴 𝘸𝘦 𝘸𝘰𝘳𝘬 𝘸𝘪𝘵𝘩 𝘰𝘧𝘵𝘦𝘯 𝘥𝘰𝘯’𝘵 𝘸𝘢𝘯𝘵 𝘵𝘰 𝘪𝘯𝘷𝘦𝘴𝘵 𝘪𝘯 𝘢 𝘱𝘳𝘰𝘫𝘦𝘤𝘵 𝘵𝘩𝘦𝘮𝘴𝘦𝘭𝘷𝘦𝘴 𝘧𝘳𝘰𝘮 𝘵𝘩𝘦 𝘣𝘦𝘨𝘪𝘯𝘯𝘪𝘯𝘨 𝘢𝘯𝘥 𝘢𝘳𝘦 𝘦𝘪𝘵𝘩𝘦𝘳 𝘭𝘰𝘰𝘬𝘪𝘯𝘨 𝘵𝘰 𝘱𝘢𝘳𝘵𝘯𝘦𝘳 𝘸𝘪𝘵𝘩 𝘢 𝘤𝘰𝘮𝘱𝘢𝘯𝘺 𝘸𝘩𝘪𝘤𝘩 𝘢𝘭𝘳𝘦𝘢𝘥𝘺 𝘩𝘢𝘴 𝘵𝘩𝘦 𝘵𝘦𝘤𝘩𝘯𝘰𝘭𝘰𝘨𝘺, 𝘮𝘢𝘵𝘶𝘳𝘦 𝘱𝘭𝘢𝘵𝘧𝘰𝘳𝘮 𝘢𝘯𝘥/𝘰𝘳 𝘬𝘯𝘰𝘸-𝘩𝘰𝘸 𝘵𝘰 𝘤𝘶𝘴𝘵𝘰𝘮𝘪𝘴𝘦 𝘵𝘰 𝘵𝘩𝘦𝘪𝘳 𝘯𝘦𝘦𝘥𝘴,” 𝘴𝘩𝘦 𝘴𝘢𝘪𝘥." Take a look 👉 https://lnkd.in/gp57yFvc $LDX #Lumos #LDX #pointofcare #diagnostics #healthcare #innovation

🩺 Australian Doctor   General practitioners (GPs) routinely assess conflicting symptoms of respiratory illness in their patients - and on the balance of available information and clinical judgement, often prescribe antibiotics on the spot. Journalist Rachel Fieldhouse has written an article for Australian Doctor - ‘New point-of-care tests promise to pick the patients who actually need antibiotics' - featuring Lumos’ FebriDx® rapid point-of-care diagnostic test, which is now approved and ready to help in Australia. FebriDx® enables healthcare professionals to distinguish between bacterial infections and non-bacterial etiology, supporting informed decisions about antibiotic prescriptions. Lumos Non-Executive Chair, Sam Lanyon, was interviewed and reflected on Lumos’ consultation with the Australian medical community. “A fast, cost-effective point-of-care test would be useful to help them provide the evidence to a patient that they don’t need antibiotics and they’re not going to be effective,” he said. “In the Australian and US context, we had exactly the same feedback. [Doctors] all articulate the same problem.” See the article here: https://bit.ly/LDX_AusDoc $LDX #LDX #Lumos #innovation #diagnostics #pointofcare #AMR #antimicrobialresistance

Investor Webinar   Lumos CEO and MD, Doug Ward, and CFO, Barrie Lambert, this week presented the Company's Q2 FY25 quarterly performance. The presentation covers recent achievements including BARDA funding for clinical trials, progress on major partnerships, and updates on product development initiatives too. Take a look: https://lnkd.in/gyGAmicE $LDX #LDX #Lumos #innovation #diagnostics #pointofcare #AMR #antimicrobialresistance

2024 was a remarkable year of achievements for Lumos Diagnostics, and we're building on this momentum in the year ahead. Check out Stockhead TV for an exclusive look at our exciting plans and future direction 👉 https://lnkd.in/gXXEUmAE $LDX #LDX #Lumos #pointofcare #medicaldevice #innovation

Take a look at this special report in Stockhead outlining Lumos' recent partnership announcement with MedPro, and the progress our Company is making to tackle the overuse of antibiotics. It's worth a read 👉 https://lnkd.in/g_yXPHt4 $LDX #LDX #Lumos #pointofcare #medicaldevice #innovation

🤝 New Partnership Lumos Diagnostics has announced a partnership with MedPro Associates to provide national contract sales coverage for FebriDx® across hospital and primary care markets in the United States. MedPro's team of more than 60 territory representatives will support sales, training and in-servicing for FebriDx®, the only point-of-care diagnostic test to distinguish between bacterial and non-bacterial infections. Lumos CEO and Managing Director, Doug Ward, commented: "We are thrilled to be working alongside MedPro to bring our products to the US Market. Their familiarity with US healthcare markets coupled with their strong customer relationships and business development expertise makes them an excellent partner." Read the ASX release 👉 https://lnkd.in/gm8-rGAS $LDX #LDX #Lumos #FDA #medicaldevice #pointofcare #invest #innovation #health #biotech #medtech #AMR

Lumos Diagnostics (ASX: LDX) has successfully launched its pivotal FebriDx® CLIA Waiver study in the United States this week, marking a significant step forward for the Company. This study will evaluate the use of the FebriDx device by untrained users in a CLIA waived setting compared to trained professionals. It will be conducted in multiple CLIA Waived clinical sites across the United States. Between 500 and 800 patients are expected to be enrolled for the study. It is anticipated to run through the US spring season 2025, after which a formal submission will be prepared for the FDA. The study, backed by BARDA's strong commitment of US$3M in funding, has already achieved its first two milestones, triggering payments to the value of US$925,217. In addition to funding, BARDA is providing study support, regulatory expertise, and support for the application to obtain a CLIA waiver from the US FDA. Lumo Managing Director, Doug Ward, commented: "We are very pleased to commence this pivotal clinical study, particularly with BARDA's invaluable support. Achieving CLIA-waived status would enable FebriDx to reach a broader market and empower healthcare providers with a reliable tool for delivering accurate and objective health insights to their patients." Read the ASX release 👉 https://lnkd.in/ggKearnp $LDX #LDX #Lumos #diagnostics #pointofcare #healthcare #rapidtest #AMR

🔹 FebriDx™ Milestone 🔹 Lumos Diagnostics has today announced that it has received approval from the Centers for Medicare and Medicaid Services (CMS) Panel for the FebriDx PLA (0442U) code to be reimbursed at a rate of US$41.38/test. The FebriDx PLA code will be published on the Clinical Lab Fee Schedule and take effect January 1,2025. The PLA code, issued by the American Medical Association, will play a vital role in securing reimbursement for FebriDx from both government and private insurers. This approval is a critical step toward enhancing FebriDx’s accessibility and adoption and is expected to facilitate broader use of the test over time, by making it more affordable. Lumos Diagnostics Managing Director, Doug Ward, commented: "This reimbursement pathway is another important step towards removing barriers to access and potentially benefitting millions of Americans.” Read the ASX release 👉 https://bit.ly/LDX-CPT-PLA $LDX #LDX #Lumos #pointofcare #diagnostics #rapidtest #innovation