Studies Validate EKF Diagnostics’ Early Stage Test for Progressive Diabetic Kidney Disease

EKF Diagnostics, the global diagnostics company, today confirms the growing weight of independent scientific evidence as validation that soluble TNF Receptors 1 and 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.

Since signing an exclusive license agreement for this novel kidney biomarker technology with the prestigious Joslin Diabetes Center (Boston, USA) in 2012, EKF Diagnostics has worked in partnership with Joslin and other key 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 new high impact studies have now been published. These independently corroborate 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 ^{1, 2}. This newly published data from eminent European research centers in France (SURDIAGNE Study Group)³ and Finland (FinnDiane Study Group)⁴ add to the expanding data set underpinning the value of sTNFR1/2 biomarkers; leading to improved diabetic patient management and outcomes through early intervention. Independently, work published from Sweden (PIVUS and ULSAM Study Groups)⁵ confirm and extend the findings to a community-based setting and to non-diabetic patients.

Highlights of the findings include:
• “For patients with sTNFR1 levels in the highest quartile, the risk of progression to ESRD was nearly 80% in 12 years” [1]
• “Our findings not only confirm the deleterious role of TNFR1 on kidney function but also point to a clear association with all-cause mortality” [3]
• “Circulating levels of sTNFR1 are independently associated with incidence of ESRD. This association is both significant and biologically plausible and appears to provide added value as a biomarker” [4]
• “Findings confirm and extend previous studies to the community-based setting supporting that sTNFRs are relevant biomarkers for kidney damage and dysfunction” [5]

This research 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 can be performed with only 50 µL of blood serum or plasma.

With the incidence of diabetes increasing globally, largely due to the dramatic increase in type 2 diabetes, it is now the leading cause (44%) of ESRD in Western Countries, requiring treatment through dialysis or kidney transplant. Since up to 40% of diabetic patients develop DKD, accurate and early identification of patients at the highest risk of progression from DKD to ESRD will enable early initiation of protective renal 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.”

References:
1. Circulating TNF Receptors 1 and 2 Predict ESRD in Type 2 Diabetes. Niewczas M, Gohda T, Skupien J, et al. J Am Soc Nephrol. 2012 Mar;23(3):507-15.
2. Circulating TNF Receptors 1 and 2 predict stage 3 CKD in Type 1 Diabetes. Ghoda T, Niewczas M, Ficociello L et al. J Am Soc Nephrol. 2012 Mar;23(3):516-24.
3. Association of Serum Concentration of TNFR1 With All-Cause Mortality in patients with Type 2 Diabetes and Chromic Kidney Disease: Follow-up of the SURDIAGENE Cohort. Saulnier, P.J. et al. Diabetes Care 2014 [In Press]
4. Added Value of Soluble Tumor Necrosis Factor Alpha Receptor-1 as a Biomarker of ESRD Risk in Patients with Type 1 Diabetes. Forsblom, C. et al. Diabetes Care 2014 [In Press]
5. Soluble TNF Receptors and Kidney Dysfunction in the Elderly. Carlsson, A.C. et al. J Am Soc Nephrol 25:…-…, 2014. Published online ahead of print February 7, 2014.