Gendius, a British health data startup, has achieved a significant milestone with its digital pre-screening technology, the CKD Screening Prioritizer (CSP), receiving a UKCA mark. This recognition establishes the CSP as a registered medical device in the UK. By utilizing readily available data, the CSP can predict whether patients with type 2 diabetes are likely to be experiencing kidney dysfunction. This allows clinicians to prioritize individuals at higher risk for screening and earlier diagnosis of chronic kidney disease (CKD). The approval of the CSP as a medical device marks the first time a CKD risk calculator has received such recognition in the UK, showcasing the growing importance of medical technology in the healthcare sector.
Ranked fourth in the MedTech 50 list, Gendius is at the forefront of developing innovative solutions for personalized care and optimized resource utilization in the face of the global chronic disease burden. As the number of individuals with type 2 diabetes continues to rise rapidly, universal screening for CKD may fail to keep pace with the increasing demand, resulting in missed or delayed diagnoses. The CSP addresses this challenge by leveraging technology to pre-screen populations, enabling more efficient allocation of screening resources based on risk.
Lead data scientist Dr. Camilla Sammut-Powell emphasized the need for early identification of CKD in individuals with type 2 diabetes, as late diagnosis hinders the ability to alter the disease’s course. The CSP was designed to identify individuals at risk of abnormal kidney function accurately. Through validation on global datasets, soon to be published in a peer-reviewed journal, Gendius demonstrated the applicability and relevance of the CSP across the global type 2 diabetes population. This groundbreaking, globally scalable solution for pre-screening CKD in people with type 2 diabetes is primed to become a ubiquitous tool supporting healthcare services globally as they tackle the mounting burden of the disease.
With diabetes being a leading cause of kidney failure worldwide, individuals with diabetes face a heightened risk of developing CKD. Despite the existence of national screening programs in many countries, nearly half of those with CKD remain undiagnosed and untreated. Ali Borazjani, head of regulatory at Gendius, expressed the significance of the UKCA mark in highlighting the compliance of the CSP with relevant regulations and standards while ensuring patient safety. Gendius expects to obtain CE approval, the European equivalent of UKCA, in the upcoming months, further cementing the CSP’s status as a safe and reliable medical device.
Transitioning to business focus, the CSP represents a breakthrough in the field of medical technology. By providing advanced predictive capabilities and prioritizing high-risk individuals for screening, the CSP empowers healthcare systems to deliver personalized care efficiently while optimizing resource utilization. As Gendius continues to innovate and address the challenges posed by chronic diseases, their achievements and recognition in the industry position them as a leading player in the MedTech sector.
