MDxHealth Outlines New Strategy
Focus on molecular diagnostic testing for personalized medicine in oncology
MDxHealth, formerly known as OncoMethylome Sciences, announced further details regarding its revised business strategy. For the past several months, MDxHealth’s management has worked very closely with the Board of Directors to define a strategic path to accelerate growth and monetization of the Company’s proprietary DNA methylation platform. MDxHealth will leverage its technologies to position itself at the forefront of the burgeoning molecular diagnostics market, providing physicians with tools to diagnose and better evaluate a patient’s cancer.
The cornerstone of MDxHealth’s new strategy is the development and commercialization of high-value molecular diagnostic, prognostic, and predictive tests, advancing personalized medicine for cancer patients. This new direction will move MDxHealth away from its historical focus on discovery and out-licensing of biomarkers for screening applications. The foundation of the new strategy is to build a company that can determine its own fate, is less dependent on priorities and timelines of licensing partners, and operates in a space with high-end service products in terms of value creation, pricing, and reimbursement. Management and the Board of Directors believe that this will enable the Company to reap the benefits of its innovative methylation platform by developing DNA-biomarkers as stand-alone diagnostic products. The Board is confident that this new direction will create improved shareholder value in the future and represents a more practical and expedient path for successful growth.
The role of DNA methylation patterns in carcinogenesis, and the full impact of these patterns on clinical cancer practice have been gaining in importance over the past five years. Rarely has a fundamental finding moved so expeditiously from research to clinical diagnostic products and applications. While basic research is continuing, the number of clinical studies and publications in the field of methylation has risen exponentially. MDxHealth’s unique and extensive intellectual property portfolio in this field puts the Company in a strong position to develop clinically meaningful cancer diagnostics expeditiously.
Specifically, MDxHealth will focus its efforts on the commercialization of proprietary assays in three major cancers, namely prostate, colon, and lung cancer. MDxHealth’s DNA-methylation biomarkers, alone or in combination with other methodologies, constitute very powerful tools to help address significant unmet medical needs. These assays will help identify the presence of cancer (diagnosis) assess the tumor aggressiveness and risk of cancer recurrence (prognosis), and help stratify patients with respect to response to therapy (prediction). The initial commercialization of these high-value tests will be carried out in collaboration with established clinical laboratories with a strong presence in the U.S. market.
Additionally, MDxHealth intends to expand its existing expertise and capabilities by offering assay development, clinical trial, and companion diagnostic test development services to pharmaceutical and major biotechnology companies developing cancer therapeutics. The Company’s biomarkers are well suited to aid in stratification of patients, which can reduce drug development costs, timelines, and increase efficacy by identifying those patients who are most likely to respond to new therapies. MDxHealth has many promising companion diagnostics biomarkers in brain, breast, lung, and colon cancer and has partnered with companies such as Merck Serono and GlaxoSmithKline Biologicals.
Through 2011 the Company intends to focus its efforts on product development and validation and the establishment of a US sales channel in the form of a service offering via a CLIA licensed laboratory. Based on the current stage of development, MDxHealth expects to focus first on the development and commercialization of a molecular test for prostate cancer in the U.S. Results from ongoing validation studies show excellent performance of MDxHealth’s prostate test compared to technologies and products currently on the market. Next, the Company plans to launch a lung cancer recurrence assay for which data has already been published in the New England Journal of Medicine. Lung cancer represents a large underserved market, in which MDxHealth’s methylation profiles may have a positive impact. In addition, MDxHealth is developing a methylation test to predict response to therapy in colorectal cancer. Furthermore, the Company’s first companion diagnostic test is currently in a Phase III FDA trial with Merck Serono’s drug cilengitide for brain cancer. MDxHealth has several other co-development projects in place with pharmaceutical companies for the development of companion diagnostic tests. The combined products of MDxHealth will be addressing a market with a revenue potential of over $1 billion per year.
To implement the new strategy MDxHealth has strengthened its management team and Board of Directors. Following the appointment of Jan Groen, Ph.D., as Chief Executive Officer to bring relevant development, commercial, operational and U.S. experience, the Company has appointed Christopher Thibodeau as Vice President Commercial Operations, Melissa Thompson as Vice President Regulatory and Quality Affairs and, most recently, James Clark, Ph.D., as Vice President Research & Development. All of these executives have a track record of over 15 years each in developing and commercializing innovative life science products and diagnostics with leading companies such as US Labs-Esoterix (now a division of LabCorp), Ventana Medical Systems (now a division of Roche), Johnson & Johnson, Inverness, GlaxoSmithKline Biologicals, and Affymetrix. Furthermore, several new, highly experienced independent directors have been appointed to the Board of Directors, including Edward L. Erickson, Mark D. Myslinski, and Hilde Windels, all of whom bring substantial management and diagnostic industry operating experience to the Board, including experience in commercializing novel cancer assays in both large and emerging companies and providing services through CLIA licensed laboratories.
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Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
