IRVINE, CA, and HERSTAL, BELGIUM – January 12, 2016 – MDxHealth SA (Euronext: MDXH.BR), today provides a preliminary update on its year-end results, reporting that it has met its market guidance for 2015 (projected annual revenues of $16-20 million and case volumes of 15,000 to 17,000). Preliminary figures for ConfirmMDx test case volumes in Q4 2015 show a 50% increase to > 5,000 tests compared to > 3,300 tests in Q4 2014. Final fiscal year 2015 results are scheduled for release on February 18, 2016.
“Our continued focus on promoting broad-based adoption of ConfirmMDx in the U.S. is producing strong results. The sharp increase in case volumes is a good indicator of our performance trajectory, and further demonstrates that strategic investments in our managed care team and sales force over the last year has proved effective.” said Dr. Jan Groen, Chief Executive Officer of MDxHealth. “We will continue to build on this positive momentum as we establish MDxHealth as the worldwide leader in molecular diagnostics solutions for urological cancers.”
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) technologies and assist physicians with the diagnosis of urologic cancers, 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.
Over 975,000 American men are diagnosed with a negative prostate biopsy each year; however approximately 25-35% of those men receive false-negative results. Under the current standard of care, prostate biopsy procedures consisting of 10-12 needle biopsy cores only sample approximately 1% of a man’s prostate. This approach leaves men at risk of undetected cancer, leading to a high rate of repeat biopsies, even on cancer-free men. There is an unmet medical need for a clinically effective diagnostic test to address this dilemma. ConfirmMDx for Prostate Cancer is able to detect an epigenetic field effect or “halo” associated with the cancerization process at the DNA level. This “halo” around a cancer lesion can be present despite cells having a normal appearance under the microscope. Thus ConfirmMDx for Prostate Cancer aids urologists in identifying truly negative men who may forego an unnecessary repeat biopsy procedure. Performance of the proprietary ConfirmMDx genes and technology has been published in 45 studies on over 5,000 patients tested. The ConfirmMDx test has qualified for Medicare reimbursement as of November 3, 2014 and is also available to more than 152 million insured lives via private health insurance plans.
| For more information:
Dr. Jan Groen, CEO
US: +1 949 812 6979
BE: +32 4 364 20 70
Amber Fennell, Chris Welsh, Hendrik Thys (PR & IR)
Consilium Strategic Communications
UK: +44 20 3709 5701
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 and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.