In early 2024, Randox, in collaboration with the University of Exeter announced regulatory UKCA approval for their T1D risk test, developed by Randox using research from the university. Today, Randox is proud to further announce the pioneering genetic test for T1D risk has received CE marking, marking the first regulatory approval of its kind anywhere in the world. The certification paves the way for the test to be deployed across Europe and internationally.
The test is the first globally to use genetics to rapidly identify individuals at high risk of developing T1D. The breakthrough allows clinicians to determine who should progress to further testing, accelerating access to emerging early-intervention therapies that must be delivered before symptoms appear.
By providing a fast, accurate genetic risk score based on up to 10 diabetes associated variants, the Randox test identifies those at greatest risk before autoantibodies develop or symptoms emerge. Individuals with elevated scores can then be referred for confirmatory antibody testing and monitoring, paving the way for effective, targeted early-stage treatment.
The biochip can also support clinical decision-making after diagnosis by helping distinguish Type 1 from Type 2 diabetes, a persistent challenge with significant consequences for treatment choice and long-term care. The CE-marked biochip provides a scalable, cost-effective foundation for national screening programs, enabling health systems to prioritize resources by screening out those at low risk and focusing monitoring on those most likely to develop the disease.
Read Randox's announcement here
