Data are Presented at the American Urological Association Annual Meeting,
6-10 May 2016, San Diego
IRVINE, CA, and HERSTAL, BELGIUM – 06 May, 2016 – MDxHealth SA (Euronext: MDXH.BR) is presenting positive data demonstrating the prognostic value of its SelectMDx® and ConfirmMDx® tests for Prostate Cancer test at the 2016 American Urological Association Annual Meeting hold between 6-10 May 2016 in San Diego, California, USA. These data, which are presented in two separate poster presentations, demonstrate that:
The application of a risk score based on SelectMDx® test results combined with traditional clinical risk factors was shown to be significantly better at stratifying men with aggressive and non-aggressive prostate cancer than current clinical methods.
The use of ConfirmMDx® to help physicians decide which men are at lower risk of harboring aggressive prostate cancer resulted in a 65% reduction in the rate of unnecessary repeat biopsies. The study showed that men with high-grade prostate cancer are most likely to be identified through a positive ConfirmMDx test result.
Dr Jan Groen, Chief Executive Officer of MDxHealth, comments: “These data offer further validation of our two flagship tests for prostate cancer and provides additional evidence that our diagnostic assays can add important information to standard clinical practices when identifying men at high risk of the aggressive form of prostate cancer. Therefore reducing the amount of unnecessary invasive biopsy procedures.”
Further details of the studies can be found below.
Identification of High-Grade Prostate Cancer using Urine-based Molecular Biomarkers Combined with Clinical Risk Factors
Sunday, May 8, 2016 1:00 PM-3:00 PM
SDCC: Room 24
Clinical Utility of an Epigenetic Assay to Reduce Unnecessary Repeat Prostate Biopsies
Sunday, May 8, 2016 8:00 AM-10:00 AM
SDCC: Room 28DE
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 side effects and costs. SelectMDx for Prostate Cancer is a proprietary urine-based, molecular diagnostic test that offers a non-invasive “liquid biopsy” method to identify patients at low risk for prostate cancer, helping to both reduce unnecessary prostate biopsy procedures with their concomitant complications and expense and to identify those men at increased risk of harbouring high-grade disease who may benefit most from earlier detection.
ConfirmMDx for Prostate Cancer is the first epigenetic, and only tissue-based test in the 2016 NCCN Guidelines for early detection of prostate cancer which addresses false negative biopsy concerns. It is the only molecular diagnostic test that provides a very high negative predictive value (NPV) of 96% for clinically significant prostate cancers, and 90% NPV for all prostate cancers, as well as prostate mapping of the test results to help guide repeat biopsies. Each year, more than 1 million American men undergo an invasive prostate biopsy with a negative result, however approximately 30% of those men actually have prostate cancer. The current standard of care for prostate biopsy procedures samples less than 1% of the prostate, leaving men at risk for undetected cancer and leading to a high rate of repeat biopsies, even on cancer-free men. ConfirmMDx for Prostate Cancer helps urologists identify low-risk men who may forego an unnecessary repeat biopsy and high-risk men who may benefit from intervention. To date nearly 2,800 urologists have ordered ConfirmMDx on more than 40,000 patients. ConfirmMDx has qualified for Medicare reimbursement and is also available to more than 152 million insured lives via private health insurance plans.
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 gene methylation (epigenetic) and other molecular technologies and assist physicians with the diagnosis of cancer, 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.
| 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
Cell: + 44 7739658783
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