Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF", the "Company")

PointMan™ collaboration with ANGLE plc

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care, central laboratory and molecular diagnostics business, announces that it has agreed a collaboration with specialist medtech company ANGLE plc (AIM: AGL), to investigate the combination of ANGLE's Parsortix circulating tumour cell (CTC) harvesting platform with EKF's PointMan™ DNA enrichment technology as a liquid biopsy.

The collaboration will initially work on colorectal cancer and then expand to cover other cancer types. CTCs will be harvested from cancer patients' blood using ANGLE's Parsortix system and then analysed using PointMan™ DNA enrichment technology (EKF Molecular Diagnostics) to identify genetic variation in the cancer. 

ANGLE believes that the combination of ANGLE's Parsortix system with EKF's PointMan™ technology may be advantageous for two reasons. Firstly, the PointMan™ system preferentially amplifies variant sequences of interest whilst suppressing amplification of the wild type i.e. normal DNA. As a result it has the potential to identify all mutations in gene sequences associated with clinical utility of targeted cancer therapies. In contrast competing genetic analysis systems generally amplify only those areas which may be predicted to be mutant and therefore may miss unexpected mutations. Secondly, the system is highly sensitive with the ability to work with very low levels of target material, potentially as low as one CTC. The high purity of the Parsortix harvest (low white blood cell contamination) and its epitope independence (does not use antibody capture) may enable the combined system to be widely deployed across different cancer types and stages of disease.

Cancer patient blood samples will in the first instance be processed under ANGLE's existing research collaboration with the University of Surrey and the Royal Surrey County Hospital. The University of Surrey Oncology Department has already processed 20 colorectal cancer patient samples with the Parsortix system and stored the harvested cells for analysis. This bank of samples is ready for analysis and should enable the collaboration to make rapid progress towards initial proof-of-principle.

If the collaboration is successful, ANGLE and EKF will explore ways to offer their respective systems as a combined solution addressing first the pharmaceutical drug trial and research use market and then, as patient data are developed, the clinical market.

ANGLE's patented Parsortix system can harvest very rare CTCs in cancer patient blood - even when there is less than one CTC in one billion healthy cells. The resulting liquid biopsy (simple blood test) enables the investigation of mutations in the patient's cancer for personalised cancer care. The Parsortix system is "open-source" and has been designed to work with all existing analytical procedures in the same way that the existing solid biopsy provides cancer cells for a wide variety of analytical procedures.

ANGLE's commercialisation strategy is to establish a series of partnerships with multiple leading diagnostic companies to offer a complete solution to the oncologist. ANGLE believes this is the optimal approach for unlocking the multi-billion dollar worldwide market available to the Company and its potential strategic partners. 

Partners will be selected for their specialist technical capabilities enabling new high medical utility applications and/or their market strength and existing installed base of diagnostic systems enabling accelerated market adoption of the Parsortix system.

Julian Baines, CEO, EKF Diagnostics Holdings plc, commented:

"Our PointMan™ DNA enrichment technology has demonstrable performance in the detection of ultra-low level mutations. The high purity of the CTCs harvested by ANGLE's Parsortix system and the absence of immunomagnetic beads gives us confidence that it will be effective with the Parsortix harvested CTCs providing rapid molecular information to the oncologist."

ANGLE's Founder and Chief Executive, Andrew Newland, commented:

"We are delighted to announce this collaboration with EKF. The combination of ANGLE's Parsortix system with EKF's PointMan™ system has the potential to provide a complete solution for the oncologist. We look forward to an early proof-of-principle." 

Enquiries:

For more information about EKF Molecular and PointMan™ please visit: www.ekfmolecular.com

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.

About ANGLE plc - www.angleplc.com

ANGLE is a specialist medtech company commercialising a disruptive platform technology that can capture cells circulating in blood, such as cancer cells, even when they are as rare in number as one cell in one billion blood cells, and harvest the cells for analysis.

ANGLE's cell separation technology is called the Parsortix system and it enables a liquid biopsy (simple blood test) to be used to provide the cells of interest. Parsortix is the subject of two granted US patents and three extensive families of patents being progressed worldwide. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The Parsortix system is established with strong positive evaluations from leading cancer research centres and is working with these cancer centres to demonstrate key applications. Parsortix has a CE Mark for Europe and FDA authorisation is in process for the US.

The analysis of the cells that can be harvested from patient blood with ANGLE's Parsortix system has the potential to help deliver personalised cancer care offering profound improvements in clinical and health economic outcomes in the treatment and diagnosis of various forms of cancer.

The increase in cancer to a 1 in 3 lifetime incidence is set to drive a multi $billion clinical market. The Parsortix system is designed to be compatible with existing major medtech analytical platforms and to act as a companion diagnostic for major pharma in helping to identify patients that will benefit from a particular drug and then monitoring the drug's effectiveness.

Now that the Parsortix system has been developed, ANGLE is focused on its commercialisation in the market.

ANGLE has established formal collaborations with world-class cancer centres and is working with these cancer centres to demonstrate key applications for its Parsortix non-invasive cancer diagnostic system as a liquid biopsy. Details are available here http://www.angleplc.com/the-company/collaborators/

As well as cancer, the Parsortix technology has the potential for deployment with several other important cell types in the future.