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An announcement from Lumos Diagnostics Holdings Ltd. ( (AU:LDX) ) is now available.
Lumos Diagnostics has secured a follow-on contract with New Jersey-based Aptatek Biosciences to manage an Institutional Review Board-approved multi-centre clinical study aimed at obtaining US Food and Drug Administration clearance for PheCheck, an aptamer-based in-home monitoring device for phenylketonuria (PKU). Valued at about US$0.4 million and scheduled to begin in the second quarter of calendar 2026 for roughly six months, the contract expands Lumos’s role beyond product development into full clinical and regulatory support, including study management, data analysis and preparation of the clinical report for FDA submission, and runs in parallel with ongoing product development and verification work; successful clearance could position Lumos for further revenue from test and reader manufacturing, strengthening its presence in the high-value rare disease diagnostics segment as PheCheck, which already holds FDA Breakthrough Device designation, targets a critical unmet need in at-home PKU monitoring.
The most recent analyst rating on (AU:LDX) stock is a Hold with a A$0.28 price target. To see the full list of analyst forecasts on Lumos Diagnostics Holdings Ltd. stock, see the AU:LDX Stock Forecast page.
More about Lumos Diagnostics Holdings Ltd.
Lumos Diagnostics Holdings Ltd is a Melbourne-based specialist in rapid, point-of-care diagnostic test technology that supports healthcare professionals in more accurately diagnosing and managing medical conditions. The company provides customized assay development and manufacturing services, proprietary digital reader platforms, and also develops, manufactures and commercializes its own Lumos-branded point‑of‑care tests focused on infectious and inflammatory diseases.
Average Trading Volume: 4,377,190
Technical Sentiment Signal: Buy
Current Market Cap: A$225.8M
For detailed information about LDX stock, go to TipRanks’ Stock Analysis page.