World’s First Genetic Type 1 Diabetes Risk Test Enables Early Detection

Type 1 Diabetes (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. 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 program to detect these early, pre-symptomatic cases. Now, a pioneering genetic test sets a new standard for diabetes diagnosis and risk stratification.

Randox Laboratories (Ireland, UK), in collaboration with the University of Exeter (Exeter, UK), has developed the world’s first T1D risk test that uses 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.

Following regulatory UKCA approval in early 2024, the pioneering genetic test for T1D risk has now 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 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.

“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,” said Dr. Peter FitzGerald, Managing Director of Randox. “New treatments to prevent or delay T1D are on the horizon, and their success hinges innovations like the biochip to 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.”

Related Links:
Randox Laboratories
University of Exeter