MDxHealth, Inc. Release: SelectMDx Outperforms PCA3 Stratifying Men For mpMRI

Published: Sep 11, 2017

Test Reduces Unnecessary Invasive Procedures

NEWS RELEASE

IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CEST, September 11, 2017 - MDxHealth SA (Euronext: MDXH.BR) today announced results from a retrospective study published in The Prostate, demonstrating that SelectMDx® for Prostate Cancer, a non-invasive liquid biopsy test, correlates with multiparametric MRI (mpMRI) and outperforms the PCA3 test.

Early diagnosis of clinically significant prostate cancer is important to choose the optimal treatment plan. Current methods such as PSA and mpMRI are helpful, but do not provide information on the biology underlying the cancer. Recent studies with the SelectMDx test have shown it can correctly identify men most likely at risk for aggressive prostate cancer.

"mpMRI has been a fast-growing technology for the detection of prostate cancer among the urology community worldwide. Studies have shown that negative predictive value of mpMRI varies between 67% and 85%. Like histopathology the interpretation and scoring of the scan heavily relies on the experience of the radiologist," said Prof. Peter Mulders, MD, PhD, Chairman of the Department of Urology at Radboud University Medical Center Nijmegen, the Netherlands. "Although more data are needed, the SelectMDx biomarker liquid biopsy test with a NPV of 98% for clinically significant cancer is a valuable diagnostic test to identify men that will most likely benefit from an mpMRI or prostate biopsy."

This retrospective study, conducted by researchers from the Radboud Medical Center, evaluated the correlation between SelectMDx and PCA3 results with mpMRI PI-RADS scores in 172 patients. One hundred (58%) patients had prostate cancer detected upon biopsy, of which 52 (52%) had high-grade disease correlated with a significantly higher SelectMDx score (p<0.01). There was a statistically significant difference in the SelectMDx score between PI-RADS 3 and 4 (p<0.01) and between PI-RADS 4 and 5 (p<0.01). The PCA3 test showed contradictory results regarding the correlation between PCA3 and mpMRI. The researchers concluded that the SelectMDx risk score could guide clinicians in identifying patients at risk for significant prostate cancer and selecting patients for further mpMRI diagnostics to reduce unnecessary procedures.

About SelectMDx 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 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 the need for MRI procedures and invasive prostate biopsies by up to 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 social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth.

For more information:

Shalon Roth, EVP, Corporate Communications & Public Affairs
MDxHealth
+44 (0)7393 906278
shalon.roth@mdxhealth.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.

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/c8205f28-6061-4f93-bc19-0af355bb4cfd

Back to news