IRVINE, Calif. & LIEGE, BELGIUM--(BUSINESS WIRE)--Regulatory News:
MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced data showing that a prototype of its Prostate ConfirmMDx™ test can help urologists distinguish patients who have a true negative biopsy from those who may have occult cancer undetected by prostate biopsy and histopathological review. If this early data is validated in a larger study, the results suggest that 30% of men suspicious for cancer after an initial negative biopsy could be spared a repeat biopsy. Prostate ConfirmMDx detects epigenetic changes in specific prostate cancer related genes, helping indicate the likely presence of cancer.
Data from the study have been published in advance online in the British Journal of Urology International (BJUI, Nov 2011), one of the leading urology publications. The authors, led by Alan Partin, MD, PhD, Chief of Urology at Johns Hopkins Medical Institution, note that this study is the first prospective trial in a defined clinical cohort with rigorous inclusion criteria to evaluate the potential utility of DNA methylation markers to predict outcome on repeat biopsy.
“Large numbers of men are subjected to repeat biopsies following an initial negative result because of persistently elevated PSA and other high-risk factors. However, cancer is found in only a minority of these men. Urologists need improved methods to help identify those men who may forego these invasive procedures,” noted Joseph Bigley, Vice President of Clinical Affairs at MDxHealth. “The results from this study suggest that testing for DNA methylation changes could reduce the number of unnecessary repeat biopsies on otherwise healthy, cancer-free men.”
About the Study
The prospectively designed study,
conducted at three prestigious U.S. urology centers (Johns Hopkins,
Walter Reed Army Medical Center, and the Cleveland Clinic Foundation)
evaluated 86 men with an initial histologically negative prostate biopsy
and characteristics that deem them high-risk for having cancer. Blinded
methylation testing was performed on paraffin embedded prostate biopsy
tissue. The relative negative predictive value (NPV), the primary
objective of the study, of the DNA methylation assay was found to be
96%. The authors recommend a larger validation study, and if similar
results were achieved, the data suggest that about 30% of men suspected
of having cancer could avoid repeat biopsies. MDxHealth is currently
conducting such a validation trial using its Prostate ConfirmMDx assay.
“This and previous studies provide important third party validation of MDxHealth’s proprietary epigenetic biomarkers. Addressing widely published concerns over false-negative biopsies, results from this study indicate that the test can assist urologists in their efforts to confirm negative biopsies,” said Dr. Jan Groen, CEO of MDxHealth. “With additional clinical validation studies for an improved version of the assay underway, we look forward to launching Prostate ConfirmMDx for urologists through our commercial CLIA laboratory in the first half of 2012.”
About Prostate Cancer
Prostate cancer is the most frequent
cancer in men worldwide, with one out of six men being diagnosed with
prostate cancer in a lifetime. In the United States approximately 30
million men are screened with the PSA test on an annual basis, leading
to more than 900,000 biopsy procedures and about 240,890 newly diagnosed
cases.
About MDxHealth
MDxHealth is a leading molecular diagnostics
company that develops and commercializes oncology-based molecular
diagnostic testing for personalized medicine. The company's tests are
based on proprietary gene methylation technology and assist physicians
with the diagnosis of cancer, prognosis of recurrence risk, and
prediction of response to a specific therapy. More information can be
found on the Company website: http://www.mdxhealth.com
or on twitter at the following address: http://www.twitter.com/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