LEX Diagnostics bids for FDA clearance after $100m takeover offer
The submission follows the revelation by Nasdaq-quoted company QuidelOrtho, based in San Diego, California, that it intended to acquire LEX from Cambridge-based TTP Group following receipt of FDA clearance.
VELO is a molecular diagnostics platform designed to deliver ultra-fast PCR results for key respiratory pathogens from a swab in under 10 minutes, advancing point-of-care testing with accurate, timely, and clinically actionable results.
Based at Melbourn Science Park, LEX Diagnostics anticipates US market clearance in late 2025 or early 2026, in alignment with expected FDA review timelines.
The FDA submission represents a pivotal step in LEX Diagnostics’ strategy and underscores the company’s commitment to advancing point-of-care testing with accurate, timely, and clinically actionable results.
CEO Ed Farrell said: “This milestone reflects the strength of our R & D and clinical validation programs, as well as our broader mission to make molecular diagnostics faster, simpler, and more accessible.
“We believe the LEX VELO system will redefine point-of-care testing by equipping healthcare providers with lab-quality results in minutes, enabling faster clinical decisions and improved patient outcomes without compromising quality while improving workflow—an achievement that will set us apart in the marketplace.”
The LEX system supports multiplex testing for key respiratory pathogens, including Influenza A, Influenza B, and COVID-19, and is engineered to deliver PCR results in six to ten minutes, easily integrating into clinical workflows across primary care settings, urgent care clinics, pharmacies, physician office laboratories and decentralised acute settings.
Its proprietary cartridge-based design eliminates the need for external liquid handling, promoting ease of use and reliability. LEX recently completed clinical studies in the United States with the VELO system and the Influenza/Covid assay during the 2024/2025 respiratory season.
Earlier this week, LEX Diagnostics’ TTP Group stablemate Cellular Highways was acquired by Canadian biotech company STEMCELL Technologies for an undisclosed sum.
Cellular Highways specialises in advanced cell sorting technologies with applications in cell and gene therapy, drug discovery, and general cell research, especially where cells are fragile. The acquisition includes the Highway1 instrument, which uses Cellular Highways’ proprietary VACS™ (Vortex-Actuated Cell Sorting) technology.
Dr. Allen Eaves, President and CEO of Vancouver-based STEMCELL said: “Since entering the market in 2024, Highway1has proven to be the fastest GMP-ready cell sorter available and is designed and manufactured under ISO 13485 certification. We are pleased to welcome this powerful instrument, along with the entire Cellular Highways platform, to STEMCELL’s portfolio of advanced cell processing instruments.
“With this new complement to our existing cell isolation and culture product lines, we look forward to further supporting scientists with the tools they need to accelerate innovation in the development of life-changing cell and gene therapies.”
Dr. Alex Jones on behalf of Cellular Highways added: “Cellular Highways customers are in great hands with STEMCELL—a major player in the global biotechnology industry with a stellar reputation for its best-in-class products and customer service. With STEMCELL’s global reach, we are excited that this acquisition will help introduce Highway1 to even more labs around the world.”
