Non-invasive, urine-based prostate cancer assay available as a laboratory developed test
IRVINE, CA, and HERSTAL, BELGIUM – March 17, 2016 – MDxHealth SA (Euronext: MDXH.BR), today announced the commercial launch of its SelectMDx(TM) for Prostate Cancer test in the United States as a laboratory developed test (LDT). Testing will be conducted at MDxHealth’s state-of-the-art CAP and CLIA accredited laboratory facilities in Irvine, California.
The proprietary SelectMDx test has been validated as a urine-based, non-invasive ‘liquid biopsy’ method to identify men at risk for aggressive, potentially lethal, prostate cancer who may benefit from an initial prostate biopsy or magnetic resonance imaging (MRI) and early detection. With a negative predictive value (NPV) of 98% for high-grade disease, SelectMDx also helps identify men at very low risk for clinically significant cancer, and could reduce unnecessary invasive biopsies by approximately 50%, thereby decreasing healthcare costs.
“Following the successful European launch of SelectMDx in late 2015, we are excited to introduce the test in the US market, complementing our existing ConfirmMDx® tissue based diagnostic test for repeat biopsy,” stated Dr. Jan Groen, Chief Executive Officer of MDxHealth. “This marks another key milestone in our commercial strategy to provide the urology community with well-validated and powerful molecular diagnostic solutions which address unmet medical needs for cancer patients.”
SelectMDx will be marketed in the US through MDxHealth’s direct national sales force of over 37 representatives and managers to the Company’s established and growing customer base of urologists and managed care providers.
About SelectMDxTM for Prostate Cancer
Of the nearly 2 million prostate biopsies performed each year, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated side effects and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive ‘liquid biopsy’ method to identify patients at low risk for prostate cancer, helping to both reduce unnecessary prostate biopsy procedures with their associated complications and expense and to identify those men at increased risk of harbouring high-grade disease who may benefit most from earlier detection.
MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company’s tests are based on proprietary genetic and epigenetic (methylation) molecular technologies and assist physicians with the diagnosis of urological cancer, prognosis of recurrence risk, and prediction of response to a specific therapy. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth.
| For more information: Dr. Jan Groen, CEO MDxHealth US: +1 949 812 6979 BE: +32 4 364 20 70 info@mdxhealth.com |
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Amber Fennell, Chris Welsh, Hendrik Thys (PR & IR) Consilium Strategic Communications UK: +44 20 3709 5701 Cell: + 44 7739658783 mdxhealth@consilium-comms.com |
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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.
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.
