Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF", the "Company")

Selah to provide testing services for Women's Health

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care, central laboratory and molecular diagnostics business, announces that Selah Genomics, Inc., its wholly owned subsidiary, based in South Carolina, US, has signed an agreement with a US national sales organisation to provide testing services for a new suite of women's health focused molecular assays. The agreement will provide a new and reliable source of revenues from a panel of well-established reimbursed tests.

The US national sales organisation has an established customer base of clinicians who currently use tests from their panel of women's health tests. Under the agreement these women's health tests will now be tested using Selah's own CLIA certified laboratory in Greenville, South Carolina, and the panel will be expanded to include the Roche cobas® HPV Test which has been running in Selah's laboratory for the last two years. The Roche cobas® HPV Test, which tests for a DNA virus that can cause cervical cancer, is the only HPV test that is FDA approved for ASC-US triage, co-testing, and first-line primary cervical screening.

The women's health panel will offer clinicians the opportunity to test samples for HPV and PAP (used for cervical screening), as well as Chlamydia, Herpes, Trichomoniasis and Vaginosis/Vaginitis.

The addition of these new testing services adds a new line of revenue for Selah and is focussed on an area of women's health which enjoys FDA approved assays and stable reimbursement levels both by Medicare and private payers. The levels of reimbursement are expected to range between US$90 and US$450 per sample depending on how many tests within the panel are required by the clinician. The Company expects over 1,000 samples to be tested each month based on current run rates.

Julian Baines, CEO of EKF commented:

"Clinicians are increasingly turning to the power of molecular genetics for early and accurate diagnoses of disease and our CLIA certified laboratory is ideally suited to undertake these tests. Selah's molecular assays used in the area of women's health is an entirely new revenue stream for the Company and allows us to diversify into an FDA approved area that has a stable reimbursement model and is a further extension of our growing portfolio of tests that offer a blend of reimbursement revenue."

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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 March 2014, EKF also announced the intention to acquire 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. Completions of the acquisitions of Selah Genomics Inc. and DiaSpect Medical AB. are expected to occur on 17 April 2014.