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Irvine, CA, United States, 2013/07/10 - MDxHealth SA announced that the New York State Department of Health (NYSDOH) has certified and granted approval for the ConfirmMDx™ for Prostate Cancer test - MDxHealth.com. NYSE Euronext: MDXH
MDxHealth SA, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support the diagnosis and treatment of cancer patients, today announced that the New York State Department of Health (NYSDOH) has certified and granted approval for the ConfirmMDx™ for Prostate Cancer test. This approval by NYSDOH completes MDxHealth's list of state licensures, allowing the Company to offer the test in all 50 states. The ConfirmMDx for Prostate Cancer test is performed on tissue obtained from a previous negative prostate biopsy to help distinguish patients who have a true-negative result and may forego an unnecessary repeat biopsy from those at high risk for missed cancer.
"The NYSDOH approval of the ConfirmMDx for Prostate Cancer test is a major milestone for MDxHealth. The Department's independent technology assessment for laboratory developed tests, which are also regulated at the federal level, is widely regarded as the most rigorous review process due to stringent quality standards. With the New York State approval and clinical laboratory license, ConfirmMDx for Prostate Cancer is now available to patients and urologists throughout the U.S. This licensure opens one of our largest potential domestic markets within the U.S., with an estimated 65,000 prostate biopsy procedures performed annually." said Dr. Jan Groen, MDxHealth's CEO. "The NYSDOH approval completes our state licensing requirements and allows us to fully execute on our U.S. commercialization strategy for this clinically significant prostate cancer test."
About ConfirmMDx for Prostate Cancer
Over 975,000 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 greater than 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. 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 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 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.
Contact: Mike Sinclair - Halsin Partners
T: +44 20 7318 2955 / C: +44 7968 022075 - E: msinclair[.]halsin.com.
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. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws.
The MDxHealth logo, MDxHealth, MDxHealth Laboratories of California, ConfirmMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners. The Company offers its services within the State of New York as MDxHealth Laboratories of California (dba).