QuidelOrtho to Acquire MDx Company LEX Diagnostics

QuidelOrtho intends to acquire full ownership of LEX Diagnostics after 510(k) clearance by the U.S. Food and Drug Administration (FDA) for consideration at closing of approximately USD 100 million. LEX Diagnostics is a molecular diagnostics company developing products designed to enhance patient care by delivering clinical insights within minutes and at the time they are most valuable. LEX Diagnostics' thermal cycling technology is designed to combine exceptional speed with high sensitivity, without compromising quality. LEX Diagnostics' ultra-fast molecular platform 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 can be reported in approximately 10 minutes. The LEX Diagnostics system integrates into point-of-care workflows, bringing the sensitivity of PCR to urgent care centers, physician office labs, hospitals and other decentralized settings at a competitive price.

In December 2023, QuidelOrtho, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, invested in LEX Diagnostics, which included the exclusive option to acquire the company up to or shortly after 510(k) clearance by the FDA. LEX Diagnostics expects to submit dual 510(k) and CLIA-waiver applications to the FDA in the coming days and expects to receive 510(k) clearance in late 2025 or early 2026, depending on FDA review timelines. QuidelOrtho also plans to discontinue its Savanna platform development. This decision reflects several factors, including the recent results of the Savanna RVP4X clinical trial. The company intends to work closely with its customers and partners to facilitate an orderly transition plan.

"Since joining QuidelOrtho one year ago, we have been engaged in a comprehensive, continuous review of our strategy to drive shareholder value. This afternoon we announced a significant step to realign our product portfolio to drive future growth. 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, QuidelOrtho. "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."

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QuidelOrtho Corporation
LEX Diagnostics