Renalytix’s KidneyIntelX Marks a New Era in Chronic Kidney Disease Management
Renalytix plc. has recently shared promising results from a Real World Evidence (RWE) study, showcasing the effectiveness of KidneyIntelX. Its advanced in vitro prognostic tool, in managing chronic kidney disease (CKD) among patients with Type 2 diabetes and diabetic kidney disease (DKD). The study monitored 2,569 patients over a 12-month period and found that KidneyIntelX’s integration into patient care was linked to significant improvements in disease management and diabetes control.
The research, executed within a leading US health system, highlighted a diverse patient group, including 27% black patients. The study revealed that when KidneyIntelX results were made available through electronic health records to primary care physicians, there was a notable 61% increase in preventative drug prescriptions for patients at high risk. This uptick in proactive care was accompanied by enhanced specialist referrals, which are known to potentially lower care costs and improve patient outcomes. Furthermore, the high-risk group experienced a rise in the number of patients achieving blood pressure control, a critical factor for cardiovascular health in CKD.
In June 2023, the Food and Drug Administration (FDA) acknowledged the potential of KidneyIntelX by granting it a de Novo Marketing Authorization for its dkd version. This endorsement points to the test’s capacity to aid roughly 14 million patients suffering from adult diabetes and kidney disease. The test has also secured extensive insurance payment coverage, including Medicare, Medicaid and Blue Cross Blue Shield programs.
Michael J. Donovan, PhD, MD, Chief Medical Officer of Renalytix, highlighted the one-year benefits of early risk assessment with KidneyIntelX and its central role in preventive medicine. He also highlighted the positive impact on cost control and health outcomes. CEO James McCullough echoed these sentiments, emphasizing the importance of integrating KidneyIntelX into the primary care framework to better manage chronic diseases that affect millions of people.
The study participants were characterized by several high-risk factors for disease progression, including a median baseline age of 68 years, a median BMI of 30 and widespread hypertension. The majority were treated by primary care physicians. The results of the RWE study showed that patients with a high risk KidneyIntelX score benefited from more frequent clinical management visits, better adherence to medication guidelines and more appropriate specialist referrals compared to patients at lower risk.
Renalytix is committed to releasing additional data in the coming months to further demonstrate the utility of KidneyIntelX as a source of actionable information that promotes preventive care and improves healthcare outcomes.
The RWE study conducted by Renalytix has demonstrated the transformative impact of KidneyIntelX on the management of chronic kidney disease and type 2 diabetes. The seamless integration of this prognostic test into electronic health records has led to improved clinical outcomes and represents a potential paradigm shift in chronic disease management. The results underscore the importance of early prevention and the potential for more effective healthcare delivery. As Renalytix continues to share additional data, the healthcare community expects to gain further insight into the benefits of this innovative approach to patient care.
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