New Study Shows MDxHealth's SelectMDx Test is Cost-Effective for Biopsy Selection

NEWS RELEASE / REGULATED INFORMATION / INSIDE INFORMATION

IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CEST, April 10, 2017 - MDxHealth SA (Euronext: MDXH.BR) today announced BJU International published a study demonstrating that its SelectMDx(TM) for Prostate Cancer test can reduce overdiagnosis and overtreatment of men at risk of prostate cancer versus PSA testing alone, leading to a reduction in total cost per patient and a quality of life improvement.¹

PSA testing is the current standard of care to determine if a patient should be selected for a prostate biopsy. However, since the test has a low-specificity for prostate cancer, it can lead to a considerable number of unnecessary, invasive procedures some of which find clinically insignificant tumors.

Researchers from leading universities in Belgium and The Netherlands used a decision-tree and mathematical model to evaluate diagnostic strategies that used SelectMDx versus PSA testing alone, to identify patients for transrectal ultrasound-guided biopsy (TRUSGB) procedures.¹ Findings indicated that a diagnostic strategy that used SelectMDx with a cut-off sensitivity of 95.7% for high-grade prostate cancer, resulted in savings of €128 and a gain of 0.025 quality-adjusted life year (QALY)* per patient compared to using PSA alone.¹

"We know from our clinical validation studies that SelectMDx is a powerful predictor of high-grade prostate cancer and can help stratify patients for biopsy," said Prof. Wim Van Criekinge, study investigator, Ghent University, Belgium and Chief Scientific Officer of MDxHealth. "However, it was interesting to see that adding SelectMDx on top of the current standard of care actually lowered healthcare costs."

Patients selected for TRUSGB using PSA testing alone had a probability of 77% to undergo an unnecessary procedure versus 36% when using SelectMDx. Therefore, 41% of these unnecessary biopsies could be prevented. The probability to find a low-grade prostate cancer was also reduced by 7%.¹

*QALY is a calculation to assess a medical intervention's impact on a person's quality of life. One QALY is equal to 1 year of life in perfect health. It is often used in economic analyses to assess a cost-benefit.

About SelectMDx for Prostate Cancer

Of the more than 2 million prostate biopsies performed each year in the US and Europe, less than a third find 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 man'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 unnecessary MRI procedures and invasive prostate biopsies by approximately 50%, thereby reducing healthcare costs.

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 Twitter at: twitter.com/mdxhealth.

For more information:

Shalon Roth, EVP Corporate Communications
MDxHealth
UK: +44 (0)7393 906278
@ShalonRoth
[email protected]

Reference:

1. Dijkstra S, et al. (2017) Cost-effectiveness of a new urinary biomarker-based risk score compared to standard of care in prostate cancer diagnostics - a decision analytical model. BJUI. [advance e-publication] doi: 10.1111/bju.13861.

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.

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/4b59c48c-6b2e-43ea-8bf1-c4c8268a1c53