Randox has announce that its pioneering genetic test for type 1 diabetes (T1D) risk has received CE marking, the first regulatory approval of its kind anywhere in the world. The test, developed by Randox in collaboration with the University of Exeter, received regulatory UK Conformity Assessed (UKCA) approval in early 2024.
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.
New drugs designed to delay or modify the onset of T1D, such as teplizumab, must be administered during the earliest stages of the disease, prior to clinical diagnosis. Yet no country currently operates a public screening programme to detect these early, pre-symptomatic cases.
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.
Dr Peter FitzGerald, Managing Director of Randox, said: “This test is a game-changer in the diagnosis and treatment of T1D. Its CE marking represents a major global milestone, enabling an opportunity to deploy this technology at scale within public and private healthcare systems worldwide. New treatments to prevent or delay T1D are on the horizon and have enormous potential to change lives. With early knowledge comes the opportunity for education, monitoring and timely intervention, potentially preventing life-threatening complications like diabetic ketoacidosis at diagnosis. We are proud to deliver the world’s first regulatory approved genetic risk test for T1D.”
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.
T1D affects more than eight million people worldwide, with numbers expected to rise sharply. While most cases are genetically driven, only one-in-ten patients has a family history, making early identification extremely difficult under current models of care.
The CE-marked biochip provides a scalable, cost-effective foundation for national screening programmes, enabling health systems to prioritise resources by screening out those at low risk and focusing monitoring on those most likely to develop the disease.