Date: 2013-02-18
Type of information:
phase:
Announcement: results
Company: MDxHealth (Belgium)
Product: ConfirmMDx™ for Prostate Cancer
Action mechanism: ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those at risk for occult cancer. The test helps urologists rule out prostate cancer-free men from undergoing unnecessary repeat biopsies and, helps rule in high risk patients who may require repeat biopsies and potential treatment. The test is able to detect an epigenetic field effect or \"halo\" associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This molecular \"halo\" around a cancer lesion can be present despite having a normal appearance under the microscope.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, UK
Trial details: The blinded, multicenter study named MATLOC (Methylation Analysis To Locate Occult Cancer), was conducted at University of Edinburgh Urological Cancer Group in the UK, the University Hospital of Liège, Belgium and the Institut de Génétique et Pathologie in Gosselies, Belgium. The investigators compared the performance of the ConfirmMDx assay to the current standard of care for men with high-risk clinical factors for prostate cancer, but negative biopsy results. Archived tissue samples from previous negative biopsies of 483 men at high risk were tested with the ConfirmMDx assay. The ConfirmMDx™ test results were then compared to the cancer detection rate in the repeat biopsies conducted on the same patients within 30 months.
Latest
news: * On February 18, 2013, MDxHealth, a molecular diagnostic company that develops and commercializes epigenetic tests to support the diagnosis and treatment of cancer patients, has announced the results of two studies of the ConfirmMDx™ for Prostate Cancer test presented at the ASCO Genitourinary Cancers Symposium 2013, February 14-16, Orlando, Florida, USA. Studies clearly show that the ConfirmMDx™ for Prostate Cancer test provides very important personalized information that cannot be achieved with traditional procedures:
• In the Epigenetic Field Effect study in Histologically Benign Prostate Biopsy Cores it was shown that GSTP1, APC and/or RASSF1 gene promoter methylation is more prevalent in histologically benign cores from prostate cancer (PCa) patients diagnosed with Gleason Score (GS) 7 PCa, as compared with low volume GS 6. This study confirms previous findings in a larger cohort of subjects that these "field effect" biomarkers can be useful for detecting cancer adjacent to histologically negative biopsies and may be indicative of occult aggressive PCa.
• The multi-gene ConfirmMDx™ for Prostate Cancer test demonstrated that epigenetic profiling is a significant predictor for PCa risk, especially to identify those men who should (not) undergo a repeat biopsy following a negative initial biopsy. An integrated risk management approach that combines this epigenetic assay with other risk factors, most notably histopathologic features of the cancer-negative initial biopsy, resulted in an improved prediction for the presence of PCa with sensitivity and negative predictive values of respectively 74% and 91%.
* On February 11, 2013, MDxHealth has announced the publication of results from a large clinical study on its epigenetic ConfirmMDx™ for Prostate Cancer test in the March 2013 issue of Journal of Urology. The results demonstrate the utility of the ConfirmMDx test as a powerful tool to address well-documented concerns over false-negative biopsy results.
In a multivariate model, correcting for age, PSA, DRE and histopathological characteristics of the first biopsy, the ConfirmMDx assay proved to be the most significant, independent predictor of patient outcome with an odds ratio of 3.17 (95% confidence interval: 1.81-5.53) along with atypical cells in the first biopsy (3.17 odds ratio; 95% confidence interval: 1.31-7.70).
The investigators report that ConfirmMDx™ accurately identified 64% of the prostate cancer-free men who could safely avoid a repeat biopsy with a negative predictive value (NPV) of 90%. Importantly, the test also correctly identified 68% of men who were harboring undetected prostate cancer at the time of their previous histopathologically negative biopsy, many presenting with clinically significant cancer upon repeat biopsy who would merit aggressive treatment.
