en.Wedoany.com Reported - Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has achieved initial progress in the U.S. commercialization of its FebriDx rapid respiratory infection test following the receipt of CLIA waiver from the U.S. FDA. Ahead of the 2026/27 flu season, the product is showing positive trends in customer adoption and reimbursement outcomes.
Currently, FebriDx has been promoted in over 100 healthcare institutions across 18 U.S. states. These institutions collectively conducted approximately 195,000 flu tests over the past year, laying the groundwork for broader application in respiratory infection management. In terms of reimbursement, over 90% of claims submitted to date have been paid, with average payment amounts exceeding the Medicare fee schedule benchmark ($41.38 per test). Lumos is leveraging the lower testing volume window during the U.S. spring and summer to build market awareness, attract new customers, advance pilot evaluations, and refine the reimbursement pathway in the CLIA-waived environment. Its commercial footprint has expanded into areas including urgent care, primary care, concierge medicine, and university health services, with progress in reimbursement from Medicare, Medicaid, and private payers.
Lumos plans to host an online investor briefing on June 11 at 10:30 AM (Australian Eastern Standard Time) to provide detailed updates on the latest commercialization progress of FebriDx. U.S. Sales Director Tommy Hall and PHASE Scientific Vice President of Commercial Operations Bob Gergen will outline the rollout since obtaining CLIA waiver status. Managing Director and CEO Doug Ward will also attend and participate in the Q&A session.
Company CEO Doug Ward stated: "Obtaining the CLIA waiver was a significant milestone, but successful commercialization also depends on demonstrating that providers can routinely use FebriDx and receive reimbursement. Although these reimbursement datasets are still in their early stages and not yet statistically significant, we are very pleased with the initial signals. They support the view that FebriDx can be embedded into routine workflows in urgent care and primary care, especially as providers prepare for the next flu season."
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