Date: 2016-06-21
Type of information: Collaboration agreement
Compound: ConfirmMDx® for Prostate Cancer test
Company: MDxHealth (Belgium) Duke University Health System (USA - NC)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: collaboration
Action mechanism: diagnostic test. 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. This molecular diagnostic test provides a 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.
Disease: prostate cancer
Details: * On June 21, 2016, MDxHealth announced that it has entered into an agreement with Duke University Health System regarding the use of its ConfirmMDx for Prostate Cancer test. The test is approved for the management of men with a previous negative prostate biopsy who may be at risk for undetected cancer and are being considered for a repeat biopsy.
"Duke Urology is consistently ranked among the top ten hospital urology programs by US News & World Reports, and we are pleased to support the care of their patients with our ConfirmMDx test," stated Dr. Jan Groen, Chief Executive Officer of MDxHealth. "Notably, ConfirmMDx is now available to patients at eight of the top ten hospital urology programs in the US."
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