About us
LEX Diagnostics is a privately held molecular diagnostics company developing products designed to enhance patient care by delivering clinical insights within minutes and at the time they are most valuable. Delivering a high-speed molecular test will redefine point-of-care diagnostics.
Our ultra-fast thermal cycling technology delivers sensitive PCR results directly from a swab sample in a user-friendly system. The LEX Diagnostics system fits seamlessly into primary care workflows, bringing the sensitivity of PCR to urgent care centres, physician’s office labs and pharmacies and at a much lower cost per test than competing molecular offerings.
History
LEX Diagnostics Ltd was founded in 2020 and joined QuidelOrtho in 2026.
We are based on the Melbourn Science Park, near Cambridge, UK.
2026
February 2026 – FDA clearance
LEX receives 510(k) clearance and CLIA waived status for its VELO Respiratory Test from U.S. Food and Drug Administration (FDA)
2025
June 2025 – FDA Application
LEX submits Dual Applications to U.S. Food and Drug Administration (FDA) seeking 510(k) clearance and CLIA waived status for its VELO system
May 2025 – ISO 13485:2016 Certification
LEX receives ISO 13485:2016 Quality Management System Certification for Design, Development and Manufacture of molecular point of care in vitro diagnostic medical devices for the diagnosis of infectious diseases
2024
December 2024 – LEX starts a clinical trial in the United States
Spring 2024 – LEX takes delivery of final pre-production prototypes
Spring 2024 – Team size increasing with focus on completing development and preparations for clinical studies
2023
Winter 2023 – LEX secures significant funding with a third party investor
November 2023 – LEX takes delivery of its near final prototypes
July 2023 – LEX appoints Heather Danks as its CTO
January 2023 – LEX appoints Ed Farrell as its new CEO
Building the team for the next stage in our journey.
2022
August 2022 – Commences ISO13485 certification activities
Appoints experienced Quality Manager to guide and support the team as we prepare for ISO13485 certification.
April 2022 – Reagent production laboratory and lyophilisation capacity expanded
Enhances in-house reagent lyophilisation capacity to support the demand of a growing R&D programme.
2021
September 2021 – LEX receives core patent grant from USPTO
The core innovation making 5 minute sample-to-answer possible is secured.
May 2021 – LEX establishes 100k/yr manufacturing line for its consumables
Secures supply for development and clinical studies and starts the journey towards high volume manufacturing.
2020
September 2020 – LEX expands the scientific team and builds new facilities
Grows and brings in-house key capabilities including custom reagent development, bioinformatics and the
manufacture of medical consumables.
February 2020 – LEX Diagnostics Ltd founded as an independent company within the TTP Group
Following successful technology demonstration TTP Group invests core intellectual property and key staff into a dedicated company with a mission to commercialise an ultrafast point-of-care diagnostic for respiratory viruses.
2018
July 2018 – Invention of ultra-fast thermal cycling technology
An internal TTP project invents a low cost, rapid thermocycling technology based on the understanding that PCR speed is not limited by biology, but by thermal cycling speed