EKF diagnostic GmbH Release: Novel EKF Biomarker Identifies People Likely To Develop Diabetic Nephropathy
New data paves way for adoption of sTNFR1 as a routine test for Diabetic Nephropathy management
Cardiff, UK – 1st December 2015 – EKF Diagnostics, the global in vitro diagnostics company, announces that new data has been presented in support of soluble Tumour Necrosis Factor Receptor 1 (sTNFR1) as a biomarker to predict progression of Diabetic Nephropathy (also referred to as Diabetic Kidney Disease). This new data [1] was recently presented at Kidney Week, the world’s premier nephrology meeting, organised 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.
Julian Baines, CEO of EKF Diagnostics commented: “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.”
Reference:
1. Adam Smiles et al. Recruitment for Clinical Trials of Interventions to Prevent ESRD in T2D Patients. Kidney Week, American Society for Nephrology, San Diego, California (3-8 November 2015).
For more information on EKF Diagnostics, please see www.ekfdiagnostics.com.
Editors’ notes
About EKF Diagnostics - www.ekfdiagnostics.com
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.
Molecular Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics following the acquisition of UK-based 360 Genomics. EKF Molecular Diagnostics’ technology, PointMan™, is capable of detecting mutant genes from tiny biopsy and blood samples and has recently entered a partnership with the world renowned cancer research center at Massachusetts General Hospital, USA.
EKF Diagnostics’ strengths lie in its multi-national research and manufacturing facilities, teams of experienced analysts and engineers in Germany, Ireland, USA and the UK, and a board led by some of world’s foremost authorities in medical diagnostics.
Cardiff, UK – 1st December 2015 – EKF Diagnostics, the global in vitro diagnostics company, announces that new data has been presented in support of soluble Tumour Necrosis Factor Receptor 1 (sTNFR1) as a biomarker to predict progression of Diabetic Nephropathy (also referred to as Diabetic Kidney Disease). This new data [1] was recently presented at Kidney Week, the world’s premier nephrology meeting, organised 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.
Julian Baines, CEO of EKF Diagnostics commented: “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.”
Reference:
1. Adam Smiles et al. Recruitment for Clinical Trials of Interventions to Prevent ESRD in T2D Patients. Kidney Week, American Society for Nephrology, San Diego, California (3-8 November 2015).
For more information on EKF Diagnostics, please see www.ekfdiagnostics.com.
Editors’ notes
About EKF Diagnostics - www.ekfdiagnostics.com
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.
Molecular Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics following the acquisition of UK-based 360 Genomics. EKF Molecular Diagnostics’ technology, PointMan™, is capable of detecting mutant genes from tiny biopsy and blood samples and has recently entered a partnership with the world renowned cancer research center at Massachusetts General Hospital, USA.
EKF Diagnostics’ strengths lie in its multi-national research and manufacturing facilities, teams of experienced analysts and engineers in Germany, Ireland, USA and the UK, and a board led by some of world’s foremost authorities in medical diagnostics.