NEWS RELEASE IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CET, February 14, 2019 - MDxHealth SA (Euronext: MDXH.BR) today announces that it has signed an exclusive distribution agreement with LifeLabs to make SelectMDx ® , the Company's non-invasive liquid biopsy prostate cancer test, available in Canada. LifeLabs is a leading Canadian company that performs over 100 million laboratory tests per year to help diagnose, treat, monitor and prevent diseases, supporting over 19 million patient visits annually.
Under the terms of the partnership agreement, LifeLabs will serve as an exclusive distributor for SelectMDx in Canada. Liquid biopsy samples will be tested in MDxHealth's state-of-the-art clinical diagnostic laboratory in Irvine, California, and LifeLabs will reimburse MDxHealth for all testing services performed.
SelectMDx, the only non-invasive liquid biopsy diagnostic test available to selectively identify patients at increased risk of aggressive prostate cancer on the basis of two RNA urine biomarkers, has been shown to have a significant impact on initial prostate biopsy decision-making. Today, the standard of care to identify patients with prostate cancer is based on invasive, and often painful, prostate biopsies. However, these procedures are often inaccurate and unnecessary, with 80% of men undergoing a biopsy having no cancer detected, of which about 25% are expected to harbor indolent cancer missed by the procedure. .
In Canada, about 60,000 prostate biopsies are performed annually, resulting in about 24,000 newly diagnosed prostate cancer patients per year, while leaving about 1.4 million at-risk Canadian men living with increased prostate-specific-antigen (PSA) levels. The Canadian Cancer Society estimates that, by 2030, the number of patients diagnosed each year with prostate cancer will increase to 42,000 from 24,000 today, mainly driven by an ageing population and lifestyle. "We are very excited to partner with MDxHealth and to provide SelectMDx to our customers across Canada," stated Charles Brown, CEO of LifeLabs. "By making this innovative, non-invasive test available, we are improving the quality of prostate cancer diagnosis and delivering healthier outcomes for Canadians." "With over 25,000 US patients tested with SelectMDx to date, the test is clearly gaining momentum to become the standard of care in diagnosing patients with increased risk for aggressive prostate cancer," said Dr. Jan Groen CEO of MDxHealth . "This partnership agreement with LifeLabs demonstrates our commitment to making SelectMDx widely available in North America and to offering a valuable and accurate alternative for patients at risk for prostate cancer."
About SelectMDx® for Prostate Cancer Of the nearly 2 million prostate biopsies performed each year, less than a third identify cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated complications and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive liquid biopsy method to assess a patient's risk for prostate cancer. SelectMDx helps identify men at increased risk of harboring aggressive, potentially lethal, prostate cancer who may benefit most from a prostate biopsy and earlier detection. The test delivers a negative predictive value (NPV) of 98% for clinically significant disease, helping to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby reducing healthcare costs. The test has been included in the 2018 European Association of Urology (EAU) clinical guidelines.
About LifeLabs LifeLabs is a Canadian-owned company with over 50 years of experience providing laboratory testing services to help healthcare providers diagnose, treat, monitor, and prevent disease in patients. In communities across British Columbia and Ontario, LifeLabs delivers cost-effective, convenient access to laboratory testing services essential for optimal outcomes in healthcare. LifeLabs employs approximately 5,400 professionally trained staff and delivers over 100 million laboratory tests, supporting over 19 million patient visits annually. In 2013, LifeLabs acquired BC Biomedical in British Columbia and CML HealthCare in Ontario making LifeLabs the largest community laboratory in Canada. LifeLabs is indirectly owned by OMERS Administration Corporation, whose interest is managed by OMERS Infrastructure Management Inc. In addition to being the first community lab to conduct non-invasive prenatal testing in Canada, LifeLabs is the first lab to provide online appointment booking for patients, non-fasting protocols and secure, online access to lab results for patients.
About MDxHealth ® 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, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company's European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth , facebook.com/mdxhealth and linkedin.com/company/mdxhealth .
For more information:
| MDxHealth Dr. Jan Groen, CEO US: +1 949 812 6979 BE: +32 4 257 70 21 info@mdxhealth.com | Consilium Strategic Communications David Daley, Chris Welsh, Jonathan Birt UK: +44 20 3709 5701 mdxhealth@consilium-comms.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.
NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AssureMDx, PredictMDx and UrNCollect are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.
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