Benzinga | Apr 5, 2021 07:11AM EDT

Multi-Center Study Finds KidneyIntelX 72% More Effective Than Current Standard of Care In Identifying Early-Stage Patients at High Risk for Kidney Disease Progression and Failure

RenalytixAI plc (LSE: RENX) (NASDAQ:RNLX), announced today that KidneyIntelX(tm) more accurately predicted progressive kidney function decline and kidney failure in a multi-center, diverse cohort of 1,146 type 2 diabetes patients with early-stage (stages 1, 2, and 3) kidney disease versus the current standard of care. The results of the study, which is the second peer-reviewed clinical validation study on KidneyIntelX, have been published in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD).

Strong performance of the KidneyIntelX platform is attributed in part to its proprietary, blood-based biomarker technologies, exclusively licensed from the Joslin Diabetes Center and the Mount Sinai Health System.

Notably, KidneyIntelX was observed to be highly effective at both ends of the risk spectrum. In the study, KidneyIntelX more accurately identified and segmented patients into three risk categories (low, intermediate and high) when compared to clinical models, including the current standard of care, the KDIGO risk stratification algorithm. When guideline-recommended urine albumin to creatinine ratio testing was performed, the positive predictive value (PPV) for progressive decline in kidney function was 69% for those scored as high-risk by KidneyIntelX versus the 40% identified as highest-risk by KDIGO categorization. This is a 72% improvement compared to standard of care. In addition, only 7% of those scored as low-risk by KidneyIntelX experienced progression (i.e., negative predictive value of 93%).

"Diabetes is one of the leading causes of kidney failure in the United States. Appropriate treatment for kidney disease is a significant challenge in type 2 diabetes patients," said Dr. Marina Basina, Clinical Professor, Medicine - Endocrinology, Gerontology, & Metabolism, Stanford Medicine and Medical Director of Inpatient Diabetes, Stanford Health Care. "Data from the KidneyIntelX risk assessment platform could significantly improve the care path for diabetes patients and delay the severe consequences of diabetic kidney disease. Identifying the risk for kidney disease complications in diabetic patients in the earlier stages of the disease is essential to improving kidney health and reducing health care costs."

Accurate segmentation of patient groups based on risk will yield benefits from targeted clinical care plans. High-risk patients identified earlier in the disease cycle can be prioritized to receive precision medicine and optimized care management to slow or arrest progressive kidney disease, while low-risk patients can avoid unnecessary treatments, follow-up visits and anxiety. KidneyIntelX has the potential to uniquely inform health care providers, insurance payors and population health managers about the expected rate of progression and risk of failure in early-stage kidney disease patients. KidneyIntelX is expected to support optimization of care delivery, improve patient outcomes and reduce the $120 billion annual cost of kidney disease to the United States Medicare system.1

"Given these additional clinical study findings, we are confident that KidneyIntelX will be adopted as part of the standard of care in assessing the risk of progressive kidney decline in individuals with early-stage diabetic kidney disease," said Michael J. Donovan, MD, Ph.D., Chief Medical Officer, RenalytixAI. "These results published in Diabetologia further validate our rigorous scientific and clinical approach, which is focused on early detection and aggressive clinical intervention for those found to be at the highest risk."

The Diabetologia article entitled, "Derivation and validation of a machine learning risk score using biomarker and electronic patient data to predict progression of diabetic kidney disease," is available at https://link.springer.com/article/10.1007/s00125-021-05444-0.