MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the publication of the clinical utility of epigenetic diagnosis to improve the management of prostate cancer. The results were published in the Journal of Oncopathology 2013;1:29-32.
In this publication, researchers from the University of Gent, Johns Hopkins and MDxHealth reported on the imminent shift towards sequencing-based diagnostic technologies utilized in obtaining a clinical diagnosis of prostate cancer anticipated in the near future. Profiling and integrating genetic and epigenetic aberrations that are implicated in prostate cancer will allow for rapid identification and development of molecular diagnostic assays. By directing efforts toward the selection of known epigenetic and genomic targets, an immediate improvement tool in the diagnosis, treatment and long-term management of these patients can be expected.
"Technological advances in the field of sequencing are redefining the era of personalized disease profiling," noted Prof Dr. Wim van Criekinge, Head of the Laboratory of Bioinformatics and Computational Genomics at the University of Gent. "Previously, profiling was limited to one modality of gene regulation, e.g. the identification of somatic mutations, without considering other changes that are occurring concomitantly. Now genomic and epigenomic profiles of all, or a very large set of, genes known to be implicated in the onset of cancer, disease progression or the prediction of therapeutic efficacy, regardless of their frequency of occurrence, can be determined simultaneously."
"Combining comprehensive, integrated, molecular profiles with clinical and therapeutic outcomes serves as a powerful, evidence-based method for the identification of biomarkers," stated Dr. Jan Groen, CEO of MDxHealth. "Applying next generation and targeted deep sequencing technologies, MDxHealth has developed tests that improve the diagnosis and treatment of prostate cancer as well as other cancer types."
About ConfirmMDx™ for Prostate Cancer
Over 650,000 American men receive a negative prostate biopsy result each year; though approximately 25% of these men may still harbor occult prostate cancer. This well-documented risk of undetected cancer, often with clinically significant Gleason scores, leads to a high rate of repeat biopsies with over 40% of men receiving at least one repeat biopsy, and many receiving a 3rd and 4th biopsy. Today's gold standard diagnostic approach is the prostate biopsy procedure, collecting 10-12 needle core biopsy samples, however this sampling represents less than 1% of a man's prostate. ConfirmMDx for Prostate Cancer is an epigenetic assay to help urologists distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test is able to detect an epigenetic field effect or "halo" associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular "halo" around a cancer lesion can be present despite having a normal appearance under the microscope. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and helps rule in high risk patients who may require repeat biopsies and potential treatment.
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, ConfirmMDx for Prostate Cancer, has been shown to help distinguish patients who have a true-negative biopsy from those who may have undetected 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 prostate, brain and lung cancers. The company is based in Irvine, California with a European headquarters in Liege, Belgium.
Mike Sinclair, MDxHealth Halsin Partners
UK: +44(0)20 7318 2955 / Cell: +44(0)79 6802 2075 - E: msinclair[.]halsin.com.
Seth Lewis, The Trout Group
US: +1 646-378-2952 - E: slewis[.]troutgroup.com.
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