QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs, and transfusion medicine, today 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.

The new CEO of LEX Diagnostics, Ed Farrell, has spoken of the Melbourn Science Park-based company’s ambition: ‘Revolutionising molecular point-of-care diagnostics with a step change in speed, sensitivity, and cost’. LEX was incubated by the TTP Group on Melbourn Science Park. For more than 20 years, TTP had been developing a series of successful point-of-care instruments across immunology, histology and diagnostics. In 2017, TTP, realising that mass adoption of molecular diagnostics at the point-of-care needed a step-change improvement, initiated an internal development programme to optimise PCR (polymerase chain reaction) hardware for point-of-care applications. In 2018, the group completed development of a low-cost PCR system for consumer genetic advice for London-centred DnaNudge. Following the successful technology demonstration, TTP Group invested core intellectual property and key staff into a dedicated company with a mission to commercialise an ultrafast point-of-care diagnostic for respiratory viruses: LEX Diagnostics was founded in 2020 as a privately-held UK molecular diagnostics company. The mission LEX was entrusted with involved developing a 5-minute multiplex PCR test designed to enhance patient care by delivering clinical insights within minutes and at the time they are most valuable. After being founded in February 2020, LEX spent the rest of the year expanding the scientific team and building new facilities, focusing on custom reagent development, bioinformatics and the manufacture of medical consumables. From left at LEX Diagnostics on Melbourn Science Park are Chairman of the Board Andrew Baker-Campbell and new CEO Ed Farrell. Picture: Keith Heppell