Lumos Diagnostics запускает масштабное расширение в США после получения одобрения FDA для теста FebriDx

Lumos Diagnostics sets up US growth push after landmark year for FebriDx Published: 20:27 25 Aug 2026 EDT Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has entered the new financial year with a significantly expanded US opportunity for its FebriDx rapid diagnostic test after securing regulatory, reimbursement and distribution milestones during the 12 months to June 30, 2026. Revenue for the year rose 6% to US$13.2 million, with FebriDx revenue surging 875%, while gross profit reached US$7.9 million at a margin of 60.1%. The adjusted EBITDA loss narrowed 19% to US$2.8 million from US$3.4 million, while the net loss after tax improved to US$5.0 million from US$7.2 million. FebriDx US opportunity expands The major development during the year was the US Food and Drug Administration granting FebriDx a Clinical Laboratory Improvement Amendments (CLIA) waiver in March. The waiver allows the test to be used in more than 300,000 CLIA-waived healthcare settings, including primary care clinics, urgent care centres, retail health outlets and community health facilities. Lumos estimates this expands the addressable US market for FebriDx by around 15 times to more than US$1 billion annually, covering more than 80 million patients. Commercial adoption has begun to build, with more than 170 healthcare locations across 24 US states ordering and using FebriDx by July 2026. Chief executive Doug Ward said reimbursement performance had also exceeded expectations, with more than 90% of claims paid. US$317 million distribution agreement Lumos also secured an exclusive US distribution agreement with PHASE Scientific valued at US$317 million over 6 years. The arrangement includes upfront payments, milestone-linked prepayments and escalating minimum purchase commitments, with Lumos receiving US$8.5 million in milestone and prepaid purchase-order payments to date. FebriDx also achieved Medicare reimbursement recognition across all seven US Medicare Administrative Contractor jurisdictions during the year. Lumos is now pursuing broader coverage through Medicare Advantage, Medicaid and private insurers as commercial adoption grows. Financial position strengthened The company's Services division generated US$8.9 million in revenue during the year, while point-of-care diagnostic product sales contributed US$4.3 million, compared with US$1.8 million a year earlier. Operating expenses increased to US$15.6 million, largely reflecting investment in the FebriDx CLIA waiver and paediatric studies and higher employee costs. Following the CLIA waiver, Lumos completed a A$20 million institutional placement and raised a further A$0.3 million through a share purchase plan, finishing June with US$15.4 million cash. Next steps Lumos will focus on translating its US regulatory and commercial progress into sustained revenue growth during the current year. Priorities include driving sales through PHASE Scientific, increasing healthcare provider adoption, expanding private payer reimbursement and scaling manufacturing capacity. The company will also progress its US paediatric FebriDx study, which is supported by US$6.2 million of non-dilutive funding from the Biomedical Advanced Research and Development Authority (BARDA). The study is assessing FebriDx in children aged 2 to 12 and, if successful, could expand the test's indicated patient population by around 20%.