EKF biomarker identifies likely development of Diabetic Nephropathy

EKF Diagnostics, the global in vitro diagnostics company, announces that new data has been presented in support of soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) as a biomarker to predict progression of Diabetic Nephropathy (also referred to as Diabetic Kidney Disease).

This new data was recently presented at Kidney Week, the world’s premier nephrology meeting, organized by the American Society for Nephrology (ASN) and is now available to view online at EKF Diagnostics’ website - www.ekfdiagnostics.com/stnfr1.html.

The study from the Joslin Diabetes Center, one of the world’s leading diabetes research institutes, includes sTNFR1 data on 1335 patients followed over a four to six year period. This study was part funded by EKF and is co-authored by EKF Diagnostics, Pfizer, Eli Lilly and leading researchers from the Joslin Diabetes Center.

The data clearly highlights the role that sTNFR1 can play in identifying diabetic patients for inclusion in clinical trials of novel therapeutic interventions to prevent or delay progression to End Stage Renal Disease (ESRD).

The current practice of clinical trial recruitment is typically limited to patients with high levels of urinary albumin excretion (or proteinuria) who may not in fact progress towards ESRD.

The study describes how the use of the novel biomarker sTNFR1 from EKF can help target patients who are most likely to exhibit progressive Diabetic Nephropathy during a clinical trial and therefore will benefit most from new treatments.

There have been several other recent publications demonstrating that elevated circulating sTNFR1 levels are strongly associated with the subsequent development of advanced Diabetic Kidney Disease (DKD) in Type I and Type 2 diabetic patients.

Consequently, this data further supports and validates use of EKF’s sTNFR1 test which is a microtitre plate, ELISA-based assay using monoclonal antibodies. The test accurately and reliably detects circulating levels of sTNFR1 in patient samples in just a few hours with minimal interference and cross-reactivity. The test is easy-to use with standard laboratory equipment and can be performed with only 50 µL of blood serum or plasma.

Diabetic Nephropathy is the leading cause of ESRD worldwide and early identification of those most at risk of progression remains a significant unmet need. The growing awareness and utility of sTNFR1 as a biomarker of progressive Diabetic Nephropathy is evident.

This large and exciting new data set confirms our own findings both here at EKF and with other collaborators. Having such impressive data presented at ASN puts us in front of the world’s leading kidney specialists and will pave the way to the adoption of sTNFR1 as a routine test in the management of Diabetic Nephropathy.”

Julian Baines, CEO of EKF Diagnostics

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