Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF", the "Company")

Contract Win and Regulatory Approval

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care, central laboratory and molecular diagnostics business, announces that it has signed a new distribution contract in China and that one of its OEM partners has received further regulatory approval across several target territories.

Contract Win

The Company has signed a new distribution contract for Biosen C-Line, its glucose and lactate analyser, with Tianjin Multiclone Trading Company in China, which could significantly increase its installed user base. The initial contract is for 1,900 analysers worth approximately €4.0m over a two and a half year period, commencing immediately. The end customer will also need to purchase consumables for the analyser, and it is anticipated that this could generate a further €2.0m of revenue over the same forecast period. Furthermore, whilst these initial revenue expectations are extremely pleasing, it is expected that these instruments will have a useful life of up to 10 years, which would significantly increase the consumables revenue for EKF.

Regulatory Approval

Additionally, EKF announces that its global German partner has received regulatory approval in China and Japan for its CompoLab TS haemoglobin instrument, which is manufactured by Diaspect, a wholly owned subsidiary of EKF.

Julian Baines, Group CEO of EKF Diagnostics said, "We are delighted to have signed up Tianjin as a new distributer in one of the key territories for diagnostic companies, where the opportunity for rapid growth is clearly significant. We are also pleased that our global German partner, a worldwide provider of infusion, transfusion and clinical nutrition has expanded its sales reach, which paves the way for further growth across Asia."

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About EKF Diagnostics Holdings plc - www.ekfdiagnostics.com

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 September 2010), Argutus Medical Limited (acquired in December 2010) and Stanbio Laboratory L.P. (acquired in June 2011). In 2013 EKF established a new subsidiary, EKF Molecular Diagnostics Ltd, to focus on molecular and companion diagnostics and acquired 360 Genomics Ltd, a business that owns diagnostics technologies for cancer gene detection.

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

In March 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. 

In March 2014, EKF acquired Separation Technology, Inc., a Florida based manufacturer of in vitro diagnostics devices for the haematology testing market. In April 2014, EKF completed the acquisitions of Selah Genomics Inc., a US based developer of molecular diagnostics for personalised medicine and DiaSpect Medical AB., a Swedish based manufacturer of point-of-care haemoglobin analysers.