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.
"It is critical that well-validated tests, especially those included in the NCCN Guidelines for the early detection of prostate cancer, are available to patients," stated Judd W Moul, MD, FACS, James H Semans Professor of Surgery, Professor of Anesthesiology, Division of Urology, Department of Surgery, Duke Cancer Institute, Duke University Medical Center. "This test is designed to identify low-risk men who may forego an unnecessary repeat biopsy procedure, but as importantly, the test may help identify men who are at increased risk for high-grade prostate cancer, meriting repeat biopsy and early intervention."
"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."
About ConfirmMDx® for Prostate Cancer
ConfirmMDx for Prostate Cancer is recommended in the 2016 NCCN Guidelines for Early Detection of Prostate Cancer for the management of men with a negative biopsy result. Each year, more than 1 million American men undergo a prostate biopsy with a negative result, however ~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 helps urologists identify men who may forego an unnecessary repeat biopsy and also distinguish high-risk men who may benefit from intervention. When ConfirmMDx is negative, the test provides a very high negative predictive value (NPV) of 96% for clinically significant prostate cancer, and 90% NPV for all prostate cancer. When the test is positive, the results indicate the likelihood of detecting aggressive, potentially lethal prostate cancer upon biopsy as well as prostate map to help guide repeat biopsies. To date, ConfirmMDx testing has been ordered by nearly 3,000 urologists and performed on over 45,000 patients. The test has qualified for Medicare reimbursement and is also available to more than 152 million insured lives via private health insurance plans.
MDxHealth (mdxhealth.com) 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.
Contact: Amber Fennell / Chris Welsh / Hendrik Thys (PR & IR)
Consilium Strategic Communications
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