British health data start-up Gendius has received a UKCA mark for its digital pre-screening technology, the CKD Screening Prioritizer (CSP).
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The CSP, which is now a registered medical device in the UK, uses readily available data to predict whether a patient is likely to be experiencing kidney dysfunction or not. This allows clinicians to risk stratify people with type 2 diabetes for undiagnosed CKD so that patients at higher risk can be prioritised for screening and diagnosed earlier.
This is the first time that a CKD risk calculator has received UK approval as a medical device.
As the global chronic disease burden continues to grow, intelligent, healthcare systems increasingly need digital solutions like the CSP to enable personalised care and smarter use of resources. The number of people with type 2 diabetes is continuing to grow rapidly and universal screening for CKD will not keep up with spiralling demand, resulting in too many missed or delayed diagnoses. Using technology to pre-screen large populations allows for more efficient targeting of screening resources through prioritisation based on risk.
Lead data scientist at Gendius, Dr Camilla Sammut-Powell, said: “We know that people with type 2 diabetes are at a higher risk of developing CKD and that CKD is often diagnosed late when it’s more difficult to change the course of the disease. Screening programs are there to enable early identification of CKD but we know that they are underperformed and too many people continue to have undiagnosed CKD. We developed the CSP to help identify these people and found that we could accurately predict which people with type 2 diabetes were likely to be experiencing abnormal kidney function.
“Our work to validate the CSP on global datasets, which is awaiting publication in a peer-reviewed journal, allowed us to demonstrate that it was applicable and relevant across the global type 2 diabetes population. Developing the first globally scalable solution for pre-screening CKD, specific to people with type 2 diabetes, is an innovation that is ahead of the curve. Its use is already needed in many areas of the world to support earlier identification of CKD and we expect that it will become commonplace, supporting healthcare services to handle the ever-increasing burden of type 2 diabetes.”
Ali Borazjani, head of regulatory, added: “Having the UKCA mark proves that the CSP complies with all applicable regulations and standards as well as the scientific validity of the patient benefit. To demonstrate that the CSP is a safe and reliable medical device, we tested performance, safety, and usability. We will keep an eye on the CSP's performance and safety during its use, and we anticipate receiving CE approval—the European counterpart of UKCA—in the coming months.”
People with diabetes are at particularly high risk of developing CKD, and diabetes is the leading cause of kidney failure across the world. A quarter of the 537 million adults living with diabetes will develop CKD in their lifetime. However, despite this well-understood risk and national screening programmes in many countries, recent research found that almost one in two people with CKD are undiagnosed and so, untreated.
