Studies Validate Early-Stage Test for Progressive Diabetic Kidney Disease

Scientific evidence from independent clinical validation studies has confirmed that novel sTNFR1/2 biomarkers can predict end-stage renal disease well in advance.

EKF Diagnostics (Cardiff, UK) has confirmed the growing weight of evidence as validation that soluble TNF Receptors 1 and 2 (sTNFR1/2) are strong biomarkers of progressive diabetic kidney disease (DKD). EKF affirms that the markers can be reliably used as diagnostic tests to predict end-stage renal disease (ESRD)—one of the greatest mortality risks in diabetics—up to 10 years in advance.

The evidence also supports and validates EKF’s sTNFR1 test—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 requires only 50 µL of blood serum or plasma.

Since signing an exclusive license agreement in 2012 for this novel kidney biomarker technology with Joslin Diabetes Center (Boston, MA, USA), EKF Diagnostics has worked with Joslin and other diabetic research centers to further validate clinical utility and develop its sTNFR1 test kit. Both sTNFR1/2 biomarkers have consistently been shown to predict risk of advanced DKD and associated renal decline with greater accuracy than other available clinical tests.

Resulting from this joint work, several important studies have now been published, independently corroborating the original research by Joslin, which reported the strong association of elevated sTNFR1/2 levels with the subsequent development of advanced DKD in Type 1 and Type 2 diabetic patients. The newly published data from research centers SURDIAGNE Study Group (France) and FinnDiane Study Group (Finland) add to the expanding data set underpinning the value of sTNFR1/2 biomarkers. Independently, work published from PIVUS and ULSAM Study Groups (Sweden) confirm and extend the findings to a community-based setting and to nondiabetic patients, supporting the relevance of these biomarkers for kidney damage and dysfunction.

Additional highlights include: For patients with sTNFR1 levels in the highest quartile, the risk of progression to ESRD was nearly 80% in 12 years; Findings not only confirm the deleterious role of TNFR1 on kidney function but also point to a clear association with all-cause mortality. Circulating levels of sTNFR1 are independently associated with incidence of ESRD.

Accurate and early identification of patients at the highest risk of progression from DKD to ESRD will enable early initiation of protective therapies with subsequent reduction in costs and improved patient outcomes. “The growing volume of newly published high-impact scientific papers certainly serves to highlight the growing awareness and value of sTNFR1/2 as biomarkers of progressive DKD,” commented Julian Baines, CEO, EKF Diagnostics; “Currently there is no accepted gold standard for the diagnosis and progression of DKD. That said, our sTNFR1 test has already been shown to add greatly to information provided by standard clinical criteria, allowing clinicians to pinpoint patients who need the most care as early as possible.”

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