--- title: "Lumos Diagnostics Achieves BARDA Paediatric Study Milestone, Secures US$720k Payment" type: "News" locale: "en" url: "https://longbridge.com/en/news/276550245.md" description: "Lumos Diagnostics has achieved a milestone in its BARDA-funded paediatric study, receiving a US$720,000 payment, bringing total BARDA funding to US$1.92 million. The study aims to evaluate FebriDx for children aged 2-12, potentially expanding its market to over US$1 billion annually. The company has secured 100% Medicare reimbursement for FebriDx and has made significant commercial progress, including a US distribution agreement valued at US$317 million. However, regulatory approval and market penetration remain uncertain, with risks tied to study outcomes and FDA timelines." datetime: "2026-02-23T00:42:44.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/276550245.md) - [en](https://longbridge.com/en/news/276550245.md) - [zh-HK](https://longbridge.com/zh-HK/news/276550245.md) generator: "portal-rs" --- # Lumos Diagnostics Achieves BARDA Paediatric Study Milestone, Secures US$720k Payment Lumos Diagnostics has announced a significant milestone in its BARDA-funded paediatric study, triggering a US$720,000 non-dilutive payment and advancing its regulatory pathway for broader FebriDx use. This marks the sixth milestone payment received under the BARDA contract. The latest payment brings the total milestone payments received from **BARDA** to **US$1.92 million** to date. The total potential **BARDA** funding across all **12** milestones stands at **US$6.198 million**. The paediatric study is designed to evaluate **FebriDx** in children aged **two** to **12** years within **CLIA**-waived settings. **FebriDx Paediatric Market Expansion** The successful completion of the paediatric study is a crucial step. The company expects the study to take approximately **12 months** to meet its endpoints for subsequent **FDA** submission. This submission has the potential to allow the use of **FebriDx** across a broader paediatric population. Currently, **FebriDx** holds **FDA 510(k)** clearance for individuals aged **12-64** years. A paediatric **CLIA**-waiver expansion could significantly broaden the total addressable market (**TAM**) for **FebriDx** in the **US**. This expansion could reach over **US$1.0 billion** annually across approximately **270,000** sites. **Regulatory and Funding Context** The funding received from **BARDA** is non-dilutive, which means it provides financial support without requiring the issuance of new shares. This bolsters **Lumos's** financial resources as it progresses its regulatory and commercial goals. **BARDA** funding has previously supported **Lumos's CLIA** waiver study and the broader regulatory pathway for **FebriDx**. In a separate but related development, **Lumos** has also secured **100%** **Medicare** reimbursement for **FebriDx** across all **seven Medicare Administrative Contractors** (**MACs**), at **US$41.38** per test. The company aims for **FDA** submission for expanded paediatric use following the paediatric study's approximately **12-month** duration. **Broader Commercial Strategy** **Lumos Diagnostics' FY25 Annual Report** outlined significant progress in the commercialisation of **FebriDx**. This included a pivotal, exclusive **US** distribution agreement with **PHASE Scientific**, with a total potential value of **US$317 million** over its **six-year** term. The company has also expanded its distribution networks, partnering with key players like **Thermo Fisher**, **MedPro Associates**, **MediGroup**, and **Henry Schein**, including expansion into **Belgium**. Additionally, **Lumos** has an ongoing development agreement with **Hologic** for an **fFN** test, which holds potential for future revenue streams. To support these initiatives, **Lumos** strengthened its balance sheet with an **A$10 million** equity raise and a binding **A$5 million** loan facility, as noted in the **FY25 Annual Report**. **Outlook and Risks** This **BARDA** milestone payment provides important non-dilutive funding and advances **Lumos Diagnostics'** regulatory pathway for the **FebriDx** test in the paediatric population. While progress is encouraging, regulatory approval and successful market penetration remain contingent on continued study outcomes and execution of commercial strategies. Investors should be aware that regulatory approval and **CLIA**-waiver are not guaranteed, paediatric study outcomes and **FDA** timelines remain uncertain, and funding depends on continued milestone achievements. ### Related Stocks - [FBT.US](https://longbridge.com/en/quote/FBT.US.md) - [CODX.US](https://longbridge.com/en/quote/CODX.US.md) - [BBH.US](https://longbridge.com/en/quote/BBH.US.md) - [XHE.US](https://longbridge.com/en/quote/XHE.US.md) - [SBIO.US](https://longbridge.com/en/quote/SBIO.US.md) - [XBI.US](https://longbridge.com/en/quote/XBI.US.md) - [IHI.US](https://longbridge.com/en/quote/IHI.US.md) - [LDX.AU](https://longbridge.com/en/quote/LDX.AU.md) - [BIB.US](https://longbridge.com/en/quote/BIB.US.md) - [PBE.US](https://longbridge.com/en/quote/PBE.US.md) - [IBB.US](https://longbridge.com/en/quote/IBB.US.md) ## Related News & Research - [FDA grants priority review to Genentech’s Enspryng for MOGAD](https://longbridge.com/en/news/298539804.md) - [Co-Diagnostics Adjourns Annual Meeting, Sets New Date](https://longbridge.com/en/news/298047178.md) - [Co-Diagnostics launches integrated cloud, mobile infrastructure in India](https://longbridge.com/en/news/297919002.md) - [Co-Diagnostics Launches Integrated Cloud and Mobile Infrastructure in India | CODX Stock News](https://longbridge.com/en/news/297919373.md) - [Koala trial doses first patient with novel KMA‑targeting CAR‑T](https://longbridge.com/en/news/298021066.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**