"Liquid biopsy" test improves health outcomes and can save over $500 million annually for the U.S. healthcare system

IRVINE, Calif., Aug. 2, 2018 /PRNewswire/ -- MDxHealth SA (OTC: MDXHF.BR) today announces that a new study validates the cost-effectiveness of the SelectMDx^® for Prostate Cancer test, a non-invasive, urine-based (liquid biopsy) test that helps identify patients at increased risk of aggressive prostate cancer. The SelectMDx test can help predict the likelihood that clinically significant prostate cancer will be found by a biopsy.

The study published in The Journal of Urology, led by researchers at the Vanderbilt University Medical Center, was designed to elucidate the cost-effectiveness of SelectMDx in a population of U.S. men with elevated PSA, a marker of prostate cancer risk. Researchers analyzed the impact of utilizing the non-invasive diagnostic test prior to prostate biopsy. The primary objective was to characterize changes in health outcomes, measured in quality-adjusted life years, and a secondary objective was evaluating healthcare costs.

The researchers found that incorporating SelectMDx resulted in an average gain of 0.045 life years, or approximately 16 days, in full health gained at a cost-savings of $1,694 for each patient undergoing biopsy. Extrapolating these data to a conservative estimate of 311,879 patients per year undergoing biopsy resulted in 14,035 life years in full health gained with an annual cost saving of more than $500 million for each cohort.

"This study demonstrated that routine use of SelectMDx to guide biopsy decision-making improves health outcomes and lowers healthcare costs associated with prostate cancer risk assessment in a population of U.S. men," said Dr. Matthew Resnick from the departments of Urologic Surgery and Health Policy at Vanderbilt University Medical Center, Nashville, TN. "We believe that this strategy improves the value of conventional risk assessment strategies through improvements in both quality and cost, the numerator and denominator of the health care value equation."

Every year, 1.3 million men in the U.S. undergo a prostate biopsy.ⁱ Although a biopsy is the only way to diagnose prostate cancer, the procedure is invasive and results in complications in 18 percent of patients, with 3 percent hospitalized for infection within 30 days.^ii,iii,iv Common complications from a prostate biopsy may include bleeding, infection, sepsis/bacteremia, urinary symptoms/retention, and sexual dysfunction.

"While biopsy is the only path to prostate cancer diagnosis, no man wants to, nor should have to, go through the uncomfortable, costly procedure if it can be avoided," said Dr. Jan Groen, Chief Executive Officer of MDxHealth. "We developed SelectMDx to help reduce unnecessary biopsies and now we have the data to show how we can both improve outcomes and save the system money."

The full paper is accessible via the online edition of The Journal of Urology.

About SelectMDx^® for Prostate Cancer
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 helps to reduce the need for MRI procedures and invasive prostate biopsies by up to 50%, thereby improving quality of life and lowering healthcare costs per patient. SelectMDx is available in the US and all EU member states. Since the introduction of the SelectMDx test in mid-2016, over 23,000 patients have been tested and 15 commercial contracts have been signed with US based insurance companies. The test has been included in the 2018 European Association of Urology (EAU) clinical guidelines.

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
Kenneth Kami 
714-931-4148
[email protected] 

CURA Strategies
Thy-Ann Nguyen 
703-479-3642
[email protected]

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.

ⁱ NCI Seer Data 2015.  www.seer.cancer.gov/statfacts/html/prost.html
ⁱⁱ Gershman et al.; Eur Uro 2016
ⁱⁱⁱ Loeb et al.; Eur Uro 2013.
^iv Loeb et al.; J Urol. 2011.

SOURCE MDxHealth

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