• New drugs are emerging for type 1 diabetes (T1D), but they can only be given before a person has a clinical diagnosis
• Now countries across the world are looking at introducing the first global screening programmes to identify who is at high risk of developing the disease, to prescribe before it is too late
• A new biochip by Randox, developed with the University of Exeter, is the first in the world to use genetics to quickly identify who is at high risk of developing T1D, filtering who should go forward for further testing and accelerating access to treatment where needed.

A new test that uses genetics to help predict who is at high risk of developing type 1 diabetes is now publicly available for the first time, following research that aims to help people across the globe access new drugs that can modify the disease.

The test could help develop new screening programmes for type 1 diabetes, as new drugs emerge which must be prescribed at early stages to be effective. The new test will also help determine type 1 from type 2 diabetes, further improving clinical decision making and treatment.

The test, developed by UK diagnostics company Randox using research from the University of Exeter, could help introduce public health screening in the UK and across the world, supporting those with a high genetic risk of developing type 1 diabetes. Now, the test has received UK regulatory approval – the first such approval issued globally. This means it will be available to consumers in the UK, through Randox Health clinics, and can be ordered online for sample collection at home and returned to Randox’s laboratories for testing.

Type 1 diabetes has a significant inherited risk. The new test is conducted on a Randox biochip which can simultaneously identify up to 10 genetic variants linked to risk for type 1 diabetes. An algorithm is then applied to assess the risk associated with the identified variants for each individual, to calculate a genetic risk score. Previous trials have shown that genetic risk scores are particularly effective in predicting risk for type 1 diabetes. This score will help identify people who don’t have diabetes but are at high risk of developing the disease in the future and can be referred for autoantibody testing to give a definitive diagnosis. The Randox biochip can also be used after diagnosis, to help identify what type of diabetes a person has, which is crucial to ensuring they get the best possible treatment and care.

Identifying those at high risk is particularly topical, as new drugs emerge that can reduce the impact of type 1 diabetes – and they can only be given at the earliest stages, before a clinical diagnosis is given. In November 2022, the US Food and Drug Administration (FDA) approved the use of teplizumab – the first disease-modifying treatment for type 1 diabetes. It can only be prescribed pre diagnosis, yet there is currently no screening programme anywhere in the world to identify early pre-clinical type 1 diabetes. The drug is not yet approved for use in the UK, however, health services globally are now considering how best to introduce public health screening programmes. Diabetes clinician Professor Richard Oram, of the University of Exeter, developed the genetic risk score based on a decade of research, and has worked with Randox on developing the new biochip. He said: “The world is waking up to the value of screening programmes for type 1 diabetes because of new drugs which must be given at the earliest stages of disease. Our new biochip is a pioneering example of how understanding a person’s background genetic risk can help identify those at highest risk, ensuring they have further antibody screening so we can efficiently identify type 1 diabetes early enough for treatment to be effective. The Randox biochip could aid in speeding up decisions

around who should be monitored and tested further, making public health screening cost effective and improving lives by increasing access to treatment.”

Type 1 diabetes affects more than eight million people worldwide, and numbers are projected to rise significantly. The disease causes the body’s own immune system to attack the beta cells which regulate blood sugar. Although the disease is primarily caused by genetics, only around one in ten people with type 1 diabetes have a family member affected, making the other nine in ten difficult to identify. Currently, they are often referred for autoantibody tests when symptoms start to show – but that can be too late to mean they are eligible for treatment.

The new fingernail-sized biochip works by applying DNA extracted from a patient’s blood sample to the biochip surface, upon which copies of the high-risk type 1 diabetes genetic variants are fixed. If a match occurs, the patient’s DNA will bind to the fixed risk variants and emit light. The pattern of positive genetic variants indicates genetic risk and an algorithm is then applied, factoring the significance of each gene variant. The higher the genetic score, the greater the risk that the individual will develop the disease. Those at high risk can then be monitored and put forward for autoantibody screening, while those at low risk need not be screened, which saves money.

Dr Lucy Chambers, Head of Research Communications at Diabetes UK, said: “We’re delighted to see that research supported by Diabetes UK has informed the development of an innovative new tool to find people at high risk of type 1 diabetes. New treatments to prevent or delay type 1 are on the horizon, and their success hinges on establishing effective screening methods to pinpoint those at higher risk. We are continuing to fund research into type 1 screening and are pleased to see new innovations that have the potential to improve lives.”

Hilary Nathan, Director of Policy and Communications at JDRF UK: “For too long, type 1 diabetes has lain silent and undetected to subsequently devastate lives and cause chaos from the first days of diagnosis. This new biochip from Randox and the University of Exeter is exciting, as the test could provide a new way to predict who is at risk from developing type 1. This knowledge then unlocks the opportunity to provide education and intervene at the earliest stages, enabling us to reduce the number of people being diagnosed with diabetic ketoacidosis, which can have traumatic and potentially fatal consequences. We are also on the cusp of a wave of transformative treatments, which can delay the onset of type 1, offering people invaluable years of life free from its burdens.”

Dr Peter FitzGerald MD of Randox said: “We’re delighted to have worked with the University of Exeter on this project to provide a screening tool to assess the genetic risk of type 1 diabetes which, aligned with autoantibody testing, can greatly improve diagnosis, patient care and access to therapeutics. As a result of our regulatory UKCA approval we will, as a world first, be providing this test through our Randox Health clinics, including within certain John Lewis stores, to private individuals in the UK from7th March. We are also releasing the test via a home-based sample self-collection kit. This test is a game-changer in the diagnosis and treatment of type 1 diabetes and we look forward to deploying the test to support public and private healthcare providers globally.”