Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF" or the "Company")

Licensing agreement for kidney markers

EKF Diagnostics Holdings plc (AIM: EKF), a worldwide manufacturer of point of care in-vitro diagnostic devices, announces that it has signed an exclusive license agreement with the Joslin Diabetes Center ("Joslin"), a teaching, research and clinical care affiliate of Harvard Medical School, to license certain novel kidney biomarker technology. The licensed biomarkers were developed by Dr. Andrzej Krolewski, MD, PhD, Head of Section on Genetics and Epidemiology, and his laboratory team at Joslin.

The licence will provide EKF's wholly owned subsidiary, Argutus Medical Ltd, with exclusive rights to the Joslin's Intellectual Property surrounding two markers, Tumor Necrosis Factor Receptor 1 and 2, that, when found elevated in the blood stream, can help identify patients with Type 1 and Type 2 diabetes at increased risk of developing end stage renal disease up to ten years in advance. Clinical tests that are currently available cannot identify people at risk of end stage renal disease with a high level of precision. 

EKF will work in partnership with the Joslin Diabetes Center to further validate the findings for the two markers and develop clinical diagnostic tests to accurately identify diabetes patients with an increased risk of developing end stage kidney disease.

"We believe these biomarkers can be very useful predictors of early and late renal function decline in patients with diabetes," says Dr. Krolewski. "Working closely with the team at EKF, we hope to translate our scientific findings to improve clinical care for patients who are at risk of kidney damage."

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. Currently, there is no accurate non-invasive test to identify patients at high risk of end stage kidney disease.

Commenting, Julian Baines, CEO of EKF Diagnostics Holdings plc, said: "We are really excited at the prospect of working with the world's most prestigious diabetes centre to deliver a genuine and tangible benefit to patient management. We have focused on the delivery of high quality diagnostic tools at EKF and this license fits well with our existing development plans for point of care tests for acute kidney injury."

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About EKF Diagnostics Holdings plc

EKF Diagnostics Holdings plc was formed in July 2010 following the acquisition of EKF-diagnostic GmbH for €14.32m and refocused its strategy to one of building a substantial point of care diagnostics business. As part of this strategy, the Group has integrated three further acquisitions, Quotient Diagnostics Limited (acquired in October 2010 for a maximum of £5.41m), Argutus Medical Limited (acquired in December 2010 for £2.18m) and Stanbio Laboratory L.P. (acquired in June 2011 for a maximum of US$25.5m).

The Company, with its head office in Cardiff and operations in London, Germany, Poland, Russia, Ireland and the US, is a leading diagnostics business, focused on the development, production and distribution of chemical reagents and analysers for the testing of Glucose, Lactate, Haemoglobin, Haematocrit and HbA1c.

In May 2011 EKF entered into a distribution agreement with Alere Inc ("Alere"), a global diagnostics company, under which Alere was appointed the exclusive distributor of EKF's CLIA waived Hemo_Control device and cuvettes in the US, Canada and United Kingdom. The device is distributed in the US under the name HemoPoint H2. 

For more information please visit the website: www.ekfdiagnostics.com

About the Joslin Diabetes Center

Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes research and clinical care organization. Joslin is dedicated to ensuring that people with diabetes live long, healthy lives and offers real hope and progress toward diabetes prevention and a cure. Joslin is an independent, nonprofit institution affiliated with Harvard Medical School.

Their mission is to prevent, treat and cure diabetes. Their vision is a world free of diabetes and its complications.

For more information , visit www.joslin.org