New data have been presented in support of the use of soluble tumor necrosis factor receptor 1 (sTNFR1) as a biomarker for predicting the progression of diabetic nephropathy, also referred to as diabetic kidney disease.

The study from the Joslin Diabetes Center, Philadelphia, includes sTNFR1 data from 1335 patients who were followed over a 4- to 6-year period.1 The data highlight 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).

In recruiting patients for participation in clinical trials of potential ESRD therapies, the current practice is to select only patients with high levels of urinary albumin excretion, or proteinuria. But such patients may or may not actually progress toward ESRD. The new study describes how use of the sTNFR1 test from EKF Diagnostics, Cardiff, UK, can help target patients who are most likely to exhibit progressive diabetic nephropathy during a clinical trial, and will therefore benefit most from potential new treatments.

EKF’s sTNFR1 test is a microtiter plate, ELISA-based assay using monoclonal antibodies. The test detects circulating levels of sTNFR1 in patient samples in a few hours, with minimal interference and cross-reactivity. Easy to perform using standard laboratory equipment, the test requires only 50 µL of blood serum or plasma.

Photo Baines Julian_crop500

Julian Baines, EKF Diagnostics.

“Diabetic nephropathy is the leading cause of ESRD worldwide, and early identification of those most at risk of progression remains a significant unmet need,” says Julian Baines, CEO of EKF Diagnostics. “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.”

The study was funded in part by EKF, and is coauthored by researchers from EKF Diagnostics; Pfizer, New York; Eli Lilly and Company, Indianapolis; and the Joslin Diabetes Center.

For more information, visit EKF Diagnostics.


  1. Smiles A, Major M, Yamanouchi M, et al. Recruitment for clinical trials of interventions to prevent ESRD in T2D patients [poster]. San Diego: American Society for Nephrology, Kidney Week, November 3–8, 2015. Available at: Diabetes Exhibition Poster – sTNFR1.pdf. Accessed December 9, 2015.