QuidelOrtho Corporation announced a strategic pivot in its molecular diagnostics portfolio, revealing plans to acquire LEX Diagnostics for approximately $100 million upon FDA clearance while discontinuing development of its Savanna platform. The move represents a significant realignment aimed at accelerating growth in the point-of-care molecular diagnostics market.
Strategic Acquisition of LEX Diagnostics
The acquisition builds on QuidelOrtho's December 2023 investment in LEX Diagnostics, which included an exclusive option to acquire the company following 510(k) clearance by the U.S. Food and Drug Administration. LEX Diagnostics expects to submit dual 510(k) and CLIA-waiver applications to the FDA in the coming days, with clearance anticipated in late 2025 or early 2026.
LEX Diagnostics has developed an ultra-fast molecular platform utilizing proprietary thermal cycling technology that combines exceptional speed with high sensitivity. The system can report positive results in approximately six minutes with a single multiplex test for the detection and differentiation of Flu A, Flu B, and COVID-19, while negative results are available in approximately 10 minutes.
"Our intended acquisition of LEX Diagnostics will strengthen and accelerate our presence in point-of-care molecular diagnostics—one of the largest and fastest-growing segments in the diagnostics industry," said Brian J. Blaser, President and Chief Executive Officer of QuidelOrtho.
Platform Performance and Market Integration
The LEX Diagnostics system is designed to integrate into point-of-care workflows, bringing PCR sensitivity to urgent care centers, physician office labs, hospitals, and other decentralized settings at a competitive price point. The technology addresses the critical need for rapid, accurate diagnostic results at the point of care, where treatment decisions are made.
Founded in 2020 as a subsidiary of TTP Group Limited and headquartered in Cambridgeshire, United Kingdom, LEX Diagnostics has focused on transforming point-of-care testing through its proprietary ultra-fast thermal cycling technology.
Savanna Platform Discontinuation
QuidelOrtho's decision to discontinue the Savanna platform development reflects a comprehensive strategic review comparing clinical trial data, investment requirements, and market opportunities. The company cited recent results from the Savanna RVP4X clinical trial as a contributing factor to the decision.
"In comparing the results of recent clinical trial data, investment requirements, and the significant market opportunity for both the Savanna and LEX Diagnostics platforms, we determined that LEX Diagnostics offers important performance advantages for customers and is better aligned with our strengths and opportunities for growth," Blaser explained.
The company plans to work closely with customers and partners to facilitate an orderly transition plan for the Savanna platform discontinuation.
Financial Outlook Maintained
Despite the strategic changes, QuidelOrtho reaffirmed its fiscal 2025 financial guidance provided on February 12, 2025. The company's current business outlook supports maintaining previously announced financial projections, with detailed assumptions available in the First Quarter 2025 Financial Results presentation.
The strategic realignment comes as QuidelOrtho continues its comprehensive review of operations following the business combination of Quidel Corporation and Ortho Clinical Diagnostics Holdings plc. The company positions itself as a world leader in in vitro diagnostics, offering expertise across immunoassay and molecular testing, clinical chemistry, and transfusion medicine.
