QuidelOrtho set to buy LEX Diagnostics for $100m after FDA approval trigger
QuidelOrtho, a global provider of in vitro diagnostic technologies based in San Diego, has announced an intention to buy LEX Diagnostics for $100m.
In December 2023, QuidelOrtho invested in LEX Diagnostics, which is based on Melbourn Science Park. The deal included an option to acquire the company up to or shortly after 510(k) clearance by the FDA, the US Food and Drug Administration.
That moment has now arrived: LEX will submit dual 510(k) and CLIA-waiver applications for its groundbreaking VELO system to the FDA in the coming days and expects to receive 510(k) clearance in late 2025 or early 2026, thereby triggering the buy-out option.
VELO is a molecular diagnostics platform designed to deliver ultra-fast PCR results for key respiratory pathogens from a swab in under 10 mins, advancing point-of-care testing with accurate, timely, and clinically actionable results. The system integrates into point-of-care workflows, bringing the sensitivity of PCR to urgent care centres, physician office labs, hospitals and other decentralised settings at a competitive price.
"Since joining QuidelOrtho one year ago, we have been engaged in a comprehensive, continuous review of our strategy to drive shareholder value," said Brian J Blaser, president and CEO of QuidelOrtho. “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.”
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 was founded in 2020 as a subsidiary of TTP Group.
