IRVINE, Calif. and HERSTAL, Belgium, May 3, 2019 /PRNewswire/ -- MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today announced positive data demonstrating the accuracy and decision making value of ConfirmMDx and SelectMDx for Prostate Cancer diagnosis, to be presented at the American Urological Association Annual Meeting (AUA 2019), taking place in Chicago, Illinois from May 3-6, 2019.
- A clinical utility study demonstrates that ConfirmMDx had a significant positive impact on repeat prostate biopsy decision-making in a US community urology practice setting.
- In a 1,956-patient clinical validation study, SelectMDx demonstrated a high sensitivity and negative predictive value for the detection of clinically significant prostate cancer.
"The studies being presented at AUA's 2019 Annual Meeting demonstrate that urologists can rely on the results of ConfirmMDx and SelectMDx as highly-accurate precision medicine tools," said Michael McGarrity, CEO of MDxHealth. "These genomic tests should be considered the standard of care for men and help guide their prostate cancer journey."
Further details of the studies can be found below. Abstracts will be presented at Poster Sessions on Saturday, May 4 from 7:00-9:00AM CDT.
Clinical utility of ConfirmMDx for prostate cancer in a community urology practice
Summary: Investigators evaluated the impact of ConfirmMDx on management of patients being considered for repeat prostate biopsy and found that ConfirmMDx had a significant impact on the decision-making in a U.S. community urology setting. This clinical utility study found that repeat biopsy rates in ConfirmMDx positive patients were six-fold higher than in ConfirmMDx negatives.
Moderated poster: MP24-02. For full abstract and list of authors, click here.
MP24-04 - A 2-gene mRNA urine test for detection of high-grade prostate cancer prior to initial prostate biopsy
Summary: This study was conducted to ensure the generalizability of SelectMDx, a 2-gene, urine-based molecular test that combines mRNA biomarkers with clinical factos to risk stratify patients for high-grade prostate cancer. Investigators found SelectMDx demonstrated high sensitivity and negative predictive value for detection of prostate cancer, which supported the use of SelectMDx to help guide initial prostate biopsy decision.
Moderated poster: MP24-04. For full abstract and list of authors, click here.
The AUA 2019 Annual Meeting takes place at the McCormick Place in Chicago, and more information is available on the meeting website.
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.
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.
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