Genetic test that predicts type 1 diabetes risk on sale in the UK

A £69 at-home test that predicts who is at risk of developing type 1 diabetes is now on sale in the UK.

Consumers will be able to pre-order the finger prick test kit online on diagnostics company Randox’s website from March 7.

It will also be available at selected John Lewis stores as well as through Randox Health clinics for £89.

The test, based on research by scientists at the University of Exeter, can identify up to 10 genetic variants linked to risk for type 1 diabetes.

The researchers said those found to be at high risk could then be prioritised for further testing.

Around 344,000 people in the UK are thought to be living with type 1 diabetes in the UK and many others remain undiagnosed as it can take months or years before symptoms are noticed.

It is an autoimmune disease where the body’s immune system mistakenly attacks and kills the cells in the pancreas that produce insulin.

There are certain genes thought to be associated with type 1 diabetes risk but having these genes alone is not enough to cause someone to develop the condition.

The researchers said people who get high scores on the test could seek further autoantibody testing for a definitive diagnosis.

Blood samples from at-home tests can be returned to Randox’s laboratories for testing where the company uses a biochip – developed with help from scientists at the University of Exeter – to identify the genetic variants linked to type 1 diabetes risk.

An algorithm is then used to calculate a genetic risk score, which may identify people at high risk of developing the disease.

The scientists said that identifying those at high risk could also help with pre-diagnosis treatment of type 1 diabetes with use of certain drugs such as teplizumab, which is yet to be approved in the UK but has been given the go-ahead in the US.

Diabetes clinician Professor Richard Oram, of the University of Exeter, 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.”

He added: “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.”

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.”

Dr Peter FitzGerald, MD of Randox, said: “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.”

The researchers said they are also working towards an NHS approval for the test to classify what type of diabetes a person has.

They added they are also working with partners, funded by National Institute for Health and Care Research, to assess how a genetic risk score test for type 1 diabetes may be used to perform population screening that could be delivered by the NHS.