QuidelOrtho Corporation announced a refocusing of its molecular diagnostics strategy, including the intent to acquire full ownership of LEX Diagnostics upon U.S. FDA 510(k) clearance for approximately $100 million. LEX Diagnostics expects to submit dual 510(k) and CLIA-waiver applications to the FDA in the coming days, with 510(k) clearance anticipated in late 2025 or early 2026.
The LEX Diagnostics Velo molecular platform is designed to deliver ultra-fast results, reporting positive results in approximately six minutes for a respiratory panel (Flu A, Flu B, and COVID-19) and negative results in about 10 minutes. This platform offers a low-cost profile for both the instrument and cartridges, along with a direct swab option and room temperature reagents.
Concurrently, QuidelOrtho plans to discontinue the development of its Savanna platform, a decision based on recent clinical trial data, investment requirements, and the significant market opportunity presented by LEX Diagnostics. Despite this strategic pivot, the company reaffirmed its full-year 2025 financial guidance.
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