EKF Molecular And Massachusetts General Hospital Announce Circulating Tumour Cell Clinical Research Collaboration

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Cardiff, UK – 23 September 2014 – EKF Diagnostics, the global diagnostics company, announces that it has entered into a two year research collaboration with Massachusetts General Hospital (MGH), a global leader in successfully bridging innovative science with state-of-the-art clinical medicine, to develop PointMan™ assays that can effectively detect treatable cancer mutations in blood samples.

The collaboration agreement has been signed following a detailed evaluation of PointMan DNA enrichment technology by MGH and will cover a two year long project focussing on lung, breast and skin cancer.

MGH will use PointMan DNA enrichment technology for the detection of genetic variation in circulating tumour cells (CTCs) isolated from a patient’s blood using MGH’s CTC-Chip instrument. CTCs are shed by primary tumors allowing the cancer to metastasise. CTCs are extremely rare in whole blood and their isolation and characterisation could offer clinicians a routine method with which to diagnose, treat and monitor the progress of various cancers. The main difficulty in successfully analysing CTCs has been the ability to detect low level mutations sufficiently and to create assays that are sensitive enough to provide meaningful data; difficulties which PointMan may be able to effectively overcome.

EKF Molecular will design and develop high sensitivity assays which will be utilised by MGH with a view to clinically validating PointMan in the detection of existing and novel mutations, a major step towards the improvement of patient outcomes in the hospital.

Andrew Webb, CEO of EKF Molecular Diagnostics Ltd, commented: “The results of an initial assessment, and now this two year collaboration, moves us even closer to the routine use of blood based tests for cancer rather than a tissue biopsy. The combination of MGH’s CTC-Chip instrument and the easy to use and quick to perform PointMan technology should make this approach to cancer detection and monitoring available, ultimately, to the majority of molecular testing laboratories.”

Dr Daniel A. Haber, Director at Massachusetts General Hospital Cancer Center and Kurt J. Isselbacher, Peter D. Schwartz Professor of Oncology, Harvard Medical School, commented: “We have been studying the sensitivity of DNA enrichment technology as a way to detect and monitor specific mutations in cancers from patients utilising circulating tumour cells isolated from a simple blood sample. I am hopeful that the combination of such technology with our CTC-Chip technology will have the potential to improve the clinical management of our patients.”

Dr Shyamala Maheswaran, of the Massachusetts General Hospital Cancer Center and Associate Professor of Oncology at Harvard Medical School, who was principal investigator for the collaboration, commented: “This study demonstrated incredible sensitivity for mutations that are relevant to lung cancer, breast cancer and melanoma. During the course of the two-year research collaboration, we will look for other potential target genes associated with these and other cancer types.”

The initial proof of concept data produced by Dr Shyamala Maheswaran’s research team at MGH using PointMan DNA Enrichment assays to detect EGFR sensitizing, as well as resistance (T790M), mutations associated with lung cancer and BRAF V600E associated with melanoma have proved enlightening. These experiments involved spiking as few as 3-10 tumour cells harbouring the appropriate mutations into white blood cells. PointMan enrichment assays reliably detected both T790M and V600E at a frequency of 10 mutant alleles (gene copies) in a background of 10,000 wild type (normal) alleles. Ongoing pilot studies have suggested an even more robust detection sensitivity of three mutant alleles in a background of 30,000 wild-type alleles.

For more information on EKF Diagnostics, please visit www.ekfdiagnostics.com.

Editors’ notes
About EKF Diagnostics
www.ekfdiagnostics.com

EKF Diagnostics Holdings plc which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, Separation Technology Inc, Diaspect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new Molecular division focuses on molecular and companion diagnostics. EKF products are sold in more than 100 countries around the globe, offering over 30 specialist product lines across its brand portfolio.

Point-of-care diagnostics: EKF Diagnostics’ expertise covers the entire in vitro diagnostics chain, from fermentation and enzyme production, to liquid reagent manufacture, design and building of world-class diagnostic devices, and distribution of rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.

Companion Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics - EKF Molecular Diagnostics develops technologies for cancer gene detection. Through its acquisition of UK-based 360 Genomics and by offering innovative products with the potential to change current DNA extraction and detection practices, EKF is addressing the fast growing companion diagnostics market.

EKF Diagnostics’ strengths lie in its multi-national research and manufacturing facilities, teams of experienced analysts and engineers in Germany, Ireland, USA and the UK, and a board led by some of world’s foremost authorities in medical diagnostics.

About PointMan™
PointMan™ provides a reliable and highly sensitive determination of the presence or absence of a mutation in the DNA sequence. Mutations are associated with diseases such as cancer and importantly the patient’s response to treatment, known as personalised healthcare.

PointMan™ works by targeting the PCR (polymerase chain reaction) towards the mutant sequence whilst suppressing the amplification of the non-mutated (wild type) sequence and this means that these enriched samples contain artificially high levels of mutated DNA, significantly enhancing detection. This drives the sensitivity of the PointMan™ technology far beyond existing PCR technology (PointMan™ can detect 1 mutant gene in 100,000 normal gene copies against the nearest technology that detects 1 in 100).

The efficiency of PointMan™ therefore maximises the use of smaller biopsy samples as well as allowing multiplexing of mutations in a single test rather than many individual tests as current competing technologies do.

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