Ekf Diagnostics Regulatory News (EKF)

EKF Diagnostics Holdings plc

("EKF", the "Company")

PointMan™ at the core of successful liquid biopsy research

EKF Diagnostics Holdings plc (AIM: EKF), the AIM listed point-of-care, central laboratory and molecular diagnostics business, announces that results from a study involving EKF's PointMan DNA enrichment technology have been accepted for publication in Clinical Cancer Research, a journal of the American Association for Cancer Research which focusses on innovative clinical cancer research studies.

The study, which brings together experts from four major US cancer centres (Massachusetts General Hospital, Harvard Medical School, The University of Texas, and Weill Cornell Medical, NY) used PointMan DNA enrichment technology for the detection of genetic variations in circulating tumour cells (CTCs) or circulating tumour DNA (ctDNA) in blood samples from lung cancer patients.

In September 2014, EKF announced a two year research collaboration with Massachusetts General Hospital  to develop PointMan assays that can effectively detect treatable cancer mutations in blood samples, and this study shows that subject to further clinical validation, liquid biopsy (tumour typing using blood as the sample source) is a realistic diagnostic opportunity with significant advantages over tissue biopsy.

The study, entitled "Detection of T790M, the acquired resistance EGFR mutation, by tumor biopsy versus non-invasive blood-based analyses", focused on identifying the epidermal growth factor receptor (EGFR) T790M mutation, which is associated with resistance to certain cancer drug treatments, using alternative methods to invasive tissue biopsies. The study identified the T790M mutation from a standard lung biopsy and then compared these results with tests on blood samples containing CTCs or ctDNA from the patient's cancer. The T790M mutation from the CTC samples was enriched using EKF Molecular Diagnostics' PointMan EGFR T790M DNA enrichment kit to enhance the sensitivity of the test procedure allowing accurate genotyping to take place.

A successful outcome of this research would be key for those developing novel EGFR inhibitors capable of overcoming T790M associated resistance, whereby clinicians will be able to use regular blood tests to monitor progress rather than painful and intrusive lung biopsies.

Julian Baines, CEO of EKF Diagnostics said: "This is the first published article to feature PointMan and, importantly, the authors are primarily from four US cancer centres that are instrumental in the 'Stand Up to Cancer' programme. These results show that liquid biopsy is well on the way to becoming a realistic diagnostic alternative to tissue biopsy, particularly when several samples need to be taken during the treatment period. Importantly this study shows that PointMan enrichment technology could become an essential part of routine blood tests for cancer diagnosis and treatment monitoring."

The article can be viewed here:

http://clincancerres.aacrjournals.org/content/early/2015/10/07/1078-0432.CCR-15-1031.abstract?sid=92fd4483-c733-4004-aaf5-4e8ff00eaabe)