New Insights on DNlite™ from CREDENCE Trial Presented at ADA Scientific Sessions
New Insights on DNlite™ from CREDENCE Trial Presented at ADA Scientific Sessions
Bio Preventive Medicine Corp. and Precision Diabetes, Inc. made a significant leap in diabetes management by unveiling new findings regarding their biomarker DNlite™ at the American Diabetes Association (ADA) 86th Scientific Sessions. This presentation brought to light the outcomes of the landmark CREDENCE trial, showcasing DNlite™ as a revolutionary tool for early renal risk assessment in patients suffering from type 2 diabetes and chronic kidney disease (CKD).
The CREDENCE trial has been pivotal in demonstrating the benefits of SGLT2 inhibitors in managing diabetic kidney disease, underscoring the importance of innovative diagnostic tools like DNlite™. This assay measures the levels of urinary post-translationally modified Fetuin-A (uPTM-FetA), a novel biomarker that correlates with kidney stress and inflammation, which could lead to progressive renal damage if left unmonitored.
In the analysis presented at the ADA, DNlite™ exhibited the ability to independently forecast adverse renal outcomes, even after adjusting for traditional renal markers such as albuminuria and estimated glomerular filtration rate (eGFR). The results indicated a clear trend: as the uPTM-FetA levels increased, so did the renal risk among the participants. i The retrospective cohort consisted of 2,429 CREDENCE trial participants, encompassing both placebo and canagliflozin-treated groups, further solidifying the assay's clinical relevance.
Key Findings from the CREDENCE Analysis
- - Independent Prediction: The DNlite™ test independently predicted adverse renal outcomes after adjusting for various variables.
- - Progressive Risk Stratification: Analysis revealed a progressive increase in renal risk corresponding to uPTM-FetA tertiles and quartiles.
- - Kaplan-Meier analyses: These analyses highlighted significant risk stratification for patients within both the treatment and placebo groups.
- - Beyond Conventional Markers: The assay provided prognostic insights that surpassed traditional metrics, including Urinary Albumin-to-Creatinine Ratio (UACR) and eGFR.
Karen Tseng, CEO of Bio Preventive Medicine, remarked, "DNlite™ reflects a unique aspect of kidney stress biology that is not fully captured by traditional renal markers. The consistency of our findings across various patient populations strengthens our confidence in the utility of this biomarker platform." She further emphasized the necessity for advanced diagnostic capabilities in addressing residual renal risk in type 2 diabetes and CKD patients.
Emeritus Investigator Ele Ferrannini from the National Research Institute of Clinical Physiology stressed that even with advancements in therapies like SGLT2 inhibitors, renal risk persists among diabetic patients. The findings suggest DNlite™ can effectively enhance renal risk assessment and improve patient outcomes by identifying those at higher risk earlier in their disease trajectory.
A Tribute to a Scientific Leader
It is with great sadness that the community acknowledges the passing of Professor Ele Ferrannini shortly before the ADA presentation. His extensive contributions to diabetes and metabolic disease research were instrumental in shaping this study. Both Bio Preventive Medicine and Precision Diabetes are dedicated to honoring his legacy and advancing this critical research.
The Future of Kidney Disease Diagnostics
As Bio Preventive Medicine and Precision Diabetes continue their mission, the companies view the DNlite™ assay as a next-generation biomarker approach that could significantly alter the landscape of diabetic kidney disease management. By enabling earlier detection and improved risk stratification, DNlite™ may very well pave the way for personalized treatments that can better cater to high-risk patients.
This development marks a major stride in diabetes care, highlighting the need for innovative solutions to identify and manage chronic conditions effectively.KEY TAKEAWAY: With DNlite™, we can potentially redefine how diabetes-related kidney risks are assessed and managed, offering hope for better outcomes in patients facing these chronic conditions.
Topics Health）
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