Comparative study of tumor biopsy v noninvasive blood-based analyses published
Cardiff, UK – 15th October 2015 – EKF Diagnostics, the global in vitro diagnostics company, announces that results from a study involving EKF Molecular’s PointMan™ DNA enrichment technology have been published in Clinical Cancer Research [1], a journal of the American Association for Cancer Research which focusses on innovative clinical cancer research studies.
The study comparing tumor biopsy with noninvasive blood-based analyses brings together experts from four major US cancer centers involved in the ‘Stand Up to Cancer’ program - Massachusetts General Hospital, Harvard Medical School, The University of Texas, and Weill Cornell Medical, NY. PointMan DNA enrichment technology was used within the study for the highly sensitive detection of genetic variations in circulating tumor cells (CTCs) in blood samples from non-small cell 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. This study shows that, subject to further clinical validation, liquid biopsy (tumor 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 circulating tumor DNA (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 scientific paper to feature PointMan and, importantly, the authors are primarily from four US cancer centers that are instrumental in the ‘Stand Up to Cancer’ program. 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 scientific paper 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
For more information on EKF Diagnostics, please visit: www.ekfdiagnostics.com, or visit www.ekfmolecular.com for further details on PointMan DNA enrichment technology.
Reference:
1. Sundarasen TK, Sequist LV, et al. Detection of T790M, the acquired resistance EGFR mutation, by tumor biopsy versus noninvasive blood-based analyses. Clin Cancer Res clincanres.1031.2015; Published OnlineFirst October 7, 2015
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, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing 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.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.
Molecular Diagnostics: In March 2013 EKF set up a new division to focus on molecular and companion diagnostics following the acquisition of UK-based 360 Genomics. EKF Molecular Diagnostics’ technology, PointMan™, is capable of detecting mutant genes from tiny biopsy and blood samples and has recently entered a partnership with the world renowned cancer research center at Massachusetts General Hospital, USA.
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.
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