The development of a diagnostic biochip to assess the genetic risk of individuals developing type 1 Diabetes, is the result of a successful partnership between leading diagnostics company, Randox and the University of Exeter.

The following case study has been prepared on the dynamic biochip’s development. With significant potential for further advancements in research and diagnostics, this active collaboration highlights how industry and academia can work together to accelerate healthcare innovation.

As a professor in Diabetes at the University of Exeter Medical School, Dr. Richard Oram specializes in the study of the biology of beta cell loss in type 1 diabetes and the clinical impact of persistent beta cell function. Working alongside Professor Michael Wheedon and Professor Andrew Hattersley, in 2014, Dr. Oram developed a method of assessing genetic risk as a single number – a genetic risk score (GRS) – that can be used to help classify what type of diabetes people have and predict future typ1 1 diabetes but to deliver a clinical test, the research would need a collaborative partnership with a global innovator in healthcare diagnostics.

Unlocking the potential of a type 1 diabetes GRS

Dr. Oram’s early research on type 1 Diabetes included studying people with varying levels of  beta cell destruction and the study of extreme early-onset type 1 diabetes diagnosed in infants under a year old. One key question was whether aggregating data for someone’s genetic risk for type 1 diabetes could be turned into a single number – a genetic risk score  and could be used to help understand the disease process or even correctly identify the type of diabetes someone had.

In parallel, it’s become increasingly apparent that there is a significant issue of incorrect classification of type 1 diabetes, affecting treatment and complications risk. Dr. Oram asked that if a ‘person’ sits in the overlap of whether they might have type 1 or type 2 diabetes, can their genes be used to help understand the disease process or even correctly identify the type of diabetes someone had.

Revolutionizing diagnosis with the type 1 diabetes GRS diagnostic tool

With the common confusion and misdiagnosis of type 1 or type 2 diabetes, it’s estimated that up to half of people with diabetes receive the wrong treatment. This information was a good indicator that a diagnostic test would be a simple method of correct diagnosis. But alongside accurate type 1 and type 2 diabetes diagnosis, the GRS research and classification model can also help:

● Identification diagnostics to understand which people with diabetes may have a genetic mutation causing it and need genome sequencing to make the diagnosis

● Predictive diagnostics to learn whether someone will develop diabetes in the future

All research showed that it was relatively easy to generate a GRS for Richard and the team’s studies and that it was clinically valuable. The next step was to translate the research into a user-friendly and affordable diagnostic test that can be widely adopted worldwide – and find a healthcare diagnostics company that could make it a reality.

Industry and academia partnerships to accelerate innovation

Together, both Randox and the University of Exeter highlight the continued importance of improving disease prediction and prevention, the collaboration showcases the power of interdisciplinary partnerships between industry and academia in advancing healthcare.

Over a four-year period, Randox developed a biochip that uses genetic markers and a robust algorithm to assess an individual’s genetic risk for type 1 diabetes accurately. Randox’s expertise in the development, manufacture, and regulatory approval of the biochip made it a reality all driven by discovery research and a clinical understanding from Dr. Oram.

With neither team being able to achieve the same results without the other, recognizing the strengths both sides can offer to accelerate healthcare innovation is the key to a successful industry/academia partnership.
As a first-generation type 1 diabetes biochip, Dr. Oram continues collaborative research with Randox to advance its potential. And to further the partnership, Randox has committed a research grant of over £2m to study genetic risk scores for other autoimmune diseases, including coeliac disease and multiple sclerosis.

For more information please visit: www.medicine.exeter.ac.uk/clinical-biomedical/business-engagement-innovation

Posted on 19th October 2023 at 11:31 am.

Written by Jordan Doherty

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