MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support the diagnosis and treatment of cancer patients, and collaborator Ghent University, today announced the results from a large, epigenetic next generation sequencing based study that establishes a sensitive and cost-effective industry standard for genome-wide DNA methylation profiling. The results were published in the March 15 PLOS One Volume 8, Issue 3 (e59068). This study is an early result of the NXTGNT Center in Pharmaco (Epi)genomics, a joint collaboration between MDxHealth and the Ghent University first announced in November 2012.
Methyl Binding Domain (MBD)-based sequencing is currently the most cost-effective method for genome-wide identification of DNA methylation. Five commercially available kits for MBD enrichment, combined with Illumina-based next generation sequencing, were evaluated using inherent sequence data characteristics and most importantly, external validation data. Overall, the results obtained confirmed the need for quality control as the scientists found consistent large-scale differences in yield, sensitivity and specificity between the various kits.
"Although epigenetics and DNA methylation are playing and increasingly important role in clinical practice, most biomarkers in use today are the result of a candidate gene approach," noted Prof Dr. Wim van Criekinge, Chief Scientific Officer of MDxHealth. "As the field of epigenetics matures, it is clear that the development of clinically useful applications requires detailed and accurate information. The different next generation sequencing-based methods evaluated are indeed accurately measuring DNA methylation profiles on a genome-wide scale, however, as reported there are major differences in yield, sensitivity and specificity. The goal of this study was to compare and harmonize industry standards, so that individual testing and comparative analyses can be conducted more objectively. Interestingly, profiling resulted in a re-discovery and validation of established markers in addition to valuable insights in the constitution of the entire epigenome. At MDxHealth, we are already applying this cutting-edge knowledge in our development of next generation epigenetic sequence products and services both for clinical and pharmaco molecular diagnostics."
MDxHealth (mdxhealth.com) is a molecular diagnostics company that develops and commercializes advanced epigenetic tests for cancer assessment and the personalized treatment of patients. The company's first commercial product, the ConfirmMDx™ for Prostate Cancer test, has been shown to help distinguish patients who have a true-negative biopsy from those who may have occult cancer. MDxHealth helps to address a large and growing unmet medical need for better cancer diagnosis and treatment information. The company has a proprietary platform and a strong epigenetic product pipeline focused on the development of products for brain and lung cancers. The company is based in Irvine, California with a European headquarters in Liege, Belgium.
Mike Sinclair, Halsin Partners
UK: +44 20 7318 2955 - C: +44 7968 022075 - E: msinclair[.]halsin.com.
Seth Lewis, Trout Group
US: +1 646-378-2952 - E: slewis[.]troutgroup.com.
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