QuidelOrtho Corporation announced a refocusing of its molecular diagnostics strategy.
This strategy includes the intent 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 $100 million and plans to discontinue the Company's Savanna platform development.
In December 2023, QuidelOrtho 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 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.
