EKF Diagnostics, the global point-of-care diagnostics business, will showcase a novel test to accurately identify diabetic patients at high risk of progression to end stage renal disease (ESRD) up to 10 years in advance of currently available tests. EKF’s new sTNFr1 test is an ELISA assay that has the potential to significantly improve diabetic patient management and outcomes. It will be highlighted at The American Diabetes Association (ADA) – 73rd Scientific Session, Chicago, Stand 982.
Currently available clinical tests cannot identify people at risk of ESRD with a high level of precision. EKF’s new sTNFr1 test accurately and reliably detects circulating levels of Soluble Tumor Necrosis Factor receptor 1 (sTNFr1) in patient samples. Recent research  has demonstrated that high circulating levels of sTNFr1 are strongly associated with progression to ESRD in patients both with and without overt nephropathy.
EKF’s ground-breaking test results are a follow up to last year’s license agreement with the prestigious Joslin Diabetes Center, Boston, USA, for the exclusive rights to its novel kidney biomarker intellectual property (TNFr1 and 2). Since the signing of last year’s agreement, EKF has worked in partnership with Joslin and other European diabetic research centres to further validate the findings [2, 3] for the two markers and to develop the new clinical diagnostic test.
The sTNFr1 test is an easy-to-use microtitre plate assay requiring minimal training. As an ELISA-based assay, standard laboratory equipment can be used to analyse just 50 µL of blood serum or plasma. It uses monoclonal antibodies to give accurate and reliable results in a few hours. Furthermore, it has minimal interference and no cross reactivity with sTNFr2.
Julian Baines, Group Chief Executive Officer of EKF Diagnostics, commented, “Our new sTNFr1 test adds greatly to information provided by standard clinical criteria and provides accurate long term prognostic information for ESRD with the potential to streamline diabetic patient management, reduce time and costs and improve patient outcome.”
Kidney complications are one of the most life-threatening complications of diabetes. About a half a million people in the US have end stage kidney disease, which requires treatment through dialysis or kidney transplantation. Nearly 44% of these cases are due to diabetes. Until the launch of EKF’s sTNFr1 test, there has been no accurate non-invasive test to identify patients at high risk of end stage kidney disease.
At ADA 2013, EKF will also be demonstrating its STAT-Site M meter for quantitative determination of ß-Hydroxybutyrate (β-HB). The STAT-Site® M ß-HB system is composed of a reflectance photometer and dry-reagent strip for rapid and accurate detection of ß-HB which is largely recognised as the standard of care in ketone testing. Since it accounts for approximately 78% of the three ketone bodies, knowing exact β-HB levels offers useful clinical information for monitoring diabetic ketoacidosis (DKA) in newly-diagnosed patients and for reducing time and cost in an intensive care unit.
This release can be viewed online at: http://www.ekfdiagnostics.com/news.aspx?id=97. For more information on EKF Diagnostics’ range of diabetes related tests and point-of- care devices, visit www.ekfdiagnostics.com.
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.
Risk of ESRD and All Cause Mortality in Type 2 Diabetes According to Circulating Levels of FGF-23 and TNFR1. Jung Eun Lee, Gohda T, Walker W, et al. PLoS One. 2013;8(3):e58007.
Baseline Markers of Inflammation Are Associated With Progression to Macroalbuminuria in Type 1 Diabetic Subjects. Lopes-Virella M, Baker N, DCCT/EDIC Research Group, et al. Diabetes Care. 2013 Mar 20 [ePub ahead of print].