Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF", the "Company")

Selah update

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care, central laboratory and molecular diagnostics business, provides an update to shareholders on reimbursement levels received by recently acquired Selah Genomics, Inc.

Palmetto GBA, the J11 Medicare Administrative Contractor ('MAC'), has revised reimbursement levels for the states where Palmetto is the MAC, namely North Carolina, South Carolina, West Virginia and Virginia. As a result, reimbursement by Medicare for Selah's drug metabolism genetic biomarkers ('DME') panel, has been reduced to US$495 per sample from US$941.

Selah's DME panel is one of a number of molecular tests in the Selah portfolio and the Directors believe the commercial rationale behind the acquisition is unaffected given the considerable opportunity for Selah to continue to add market share. As a result, the reduction in the Medicare reimbursement level for the DME panel has no impact on management's expectations for EKF as a whole.

Julian Baines, CEO of EKF commented:

"Whilst we would clearly have preferred reimbursement levels to have remained higher we are confident that Selah's overall portfolio will deliver an enhanced return to our shareholders. Selah's sales force has established relationships with over 300 physicians, a six-fold increase since October 2013, and we expect to see a considerable increase in revenues from Selah through the rest of this year and beyond."

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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 for a total consideration of $4.0m (c.£2.4m). 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.