MDxHealth establishes US CLIA laboratory in Irvine, CA, and makes key hires to expand US team
DURHAM, NC, and LIEGE, BELGIUM - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized medicine, announced today that it has signed a lease agreement for a state-of-the-art laboratory and office facilities in Irvine, CA and has filed for CLIA certification of the US site. In addition, MDxHealth has filed for CLIA certification of its Liege facility.
The two-pronged commercialization strategy of the company is built on the development of companion diagnostics with top tier pharmaceutical companies, and on developing its own proprietary diagnostic, prognostic and predictive assays for a number of cancer indications to be commercialized through its CLIA laboratories. MDxHealth expects to launch its first assay for prostate cancer in 2012.
In conjunction with identifying a prime 13,448 square foot location in Irvine, MDxHealth has hired Miriam Reyes, as Senior Director Laboratory Operations, and Beth Davis as Senior Director Managed Care. Both bring extensive experience in molecular cancer diagnostics to MDxHealth. MDxHealth is building a world class scientific and commercial team for its US operations and plans further expansion in the months ahead. In September 2010, the company already announced the appointments of Dr. Melissa A. Thompson as Vice President Regulatory Affairs and Quality Assurance, and of Christopher Thibodeau as Vice President Commercial Operations.
“Establishing a US infrastructure that includes CLIA certification will allow us to penetrate the US market more efficiently and is key to our long-term business strategy,” said Dr. Jan Groen, CEO of MDxHealth. “Irvine is a hotbed for the healthcare industry and an excellent location for our company to attract the best and brightest talent, and our site is large enough to accommodate our growth over the next few years. I am also very pleased that we were able to attract two highly experienced industry professionals to manage laboratory operations and reimbursement.”
In the US, the Centers for Medicare & Medicaid Services (CMS) regulates laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing. A CLIA lab is a laboratory that operates under CLIA supervision. In total, CLIA covers approximately 200,000 laboratory entities. Unlike in Europe, in the US almost 70% of laboratory testing is outsourced to commercial CLIA labs. This constitutes a highly attractive commercial market, as one CLIA lab can service the entire US.
MDxHealth is a leading molecular diagnostics company that develops and commercializes oncology-based molecular diagnostic testing and companion diagnostics for personalized medicine. The company’s numerous cancer tests are based on proprietary gene methylation technology and assist physicians with the diagnosis of cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. MDxHealth collaborates with leading cancer research centers such as Johns Hopkins University, Harvard Medical School, Beth Israel Deaconess Medical Center, Cleveland Clinic, Duke University, University of California Los Angeles, Lovelace Respiratory Research Institute, University of Colorado Medical Center, and major European academic medical centers. The company has a number of commercial and collaborative partnerships with LabCorp, Merck & Co./Schering Plough, GlaxoSmithKline Biologicals, Roche, Merck KGaA, Qiagen, Pfizer and other industry leaders.
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation
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