Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF" or the "Company")

NICE guidance on type 2 diabetes risk identification

EKF Diagnostics Holdings plc (AIM: EKF), a worldwide manufacturer of point of care in-vitro diagnostic devices, announces that the National Institute of Clinical Excellence (NICE) have released public health guidance on the prevention of type 2 diabetes which recommend a two stage risk identification process including blood tests for glycated haemoglobin (HbA1c). The guidance is welcomed by EKF, in particular the recognition that HbA1c can be used in identifying adults at risk of diabetes.

Public Health Guidance 38 'Preventing type 2 diabetes: risk identification and interventions for individuals at high risk' is directed at all UK healthcare providers involved in identifying people at risk of type 2 diabetes and those involved in preventing or delaying the onset of this debilitating disease. Full details of the guidance are available online: http://guidance.nice.org.uk/PH38/Guidance/pdf/English

The guidance outlines diabetes risk assessment procedures, a two stage risk identification process including blood tests for haemoglobin A1c (HbA1c) and intervention strategies based on identified risk level. The guidance recommends that patients identified at potential high risk of developing type 2 diabetes are offered a blood test for HbA1c or a fasting plasma glucose test.

Julian Baines, CEO of EKF Diagnostics supported the NICE guidance saying:

"We welcome the NICE guidance, particularly the recognition that HbA1c can be used in identifying adults at risk of developing diabetes. Our Quo-Test and Quo-Lab range of HbA1c analysers will greatly aid UK health providers in identifying at risk individuals. The EKF analysers will also help in continuously monitoring at risk groups and monitoring disease and treatment status in patients who are diagnosed with diabetes.

 "The certified accuracy and ease of use of the Quo-Test and Quo-Lab analysers will allow care providers to rapidly establish preventative treatment programmes for at risk individuals. This rapid intervention reduces overall treatment costs, because in many at risk cases, simple lifestyle changes, to diet or physical activity levels for example, are sufficient to reduce the chances of disease onset.

"The EKF Quo-Test and Quo-Lab analysers provide easy and reliable measurement of HbA1c used in the detection and management of diabetes. The analysers use methodology traceable to DCCT and IFCC reference material and provide fast, accurate results in just four minutes from 4μl of blood using either finger prick or venous samples."

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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