False Negative Biopsy Dilemma
Approximately 700,0001,2 American men receive a negative prostate biopsy result; however approximately 25%3 of these results are false-negative. Under the current standard of care, prostate biopsy procedures collect 10-12 needle biopsy cores on average, effectively sampling less than 1% of a man’s prostate. This approach leaves men at risk of occult cancer, leading to a high rate of repeat biopsies, often on cancer-free men. ConfirmMDx for Prostate Cancer addresses the unmet medical need for a clinically effective diagnostic test to address this dilemma.
ConfirmMDx for Prostate Cancer is an epigenetic assay to help distinguish patients who have a true-negative biopsy from those who may have 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.
ConfirmMDx Field Effect
ConfirmMDx detects an epigenetic field effect or “halo” associated with the cancerization process at the DNA level in cells adjacent to cancer foci. This epigenetic “halo” around a cancer lesion can be present despite having a normal appearance under the microscope.3
ConfirmMDx Clinical Utility
ConfirmMDx Prostate Mapping (sample report)
ConfirmMDx Clinical Validity
1) National Cancer Institute Trends Progress Report-2009/2010 Updated 2) NCI SEER Prostate Cacner Statistics 2012 3) Predicting cancer following a diagnosis of high-grade prostatic intraepithelial neoplasia on needle biopsy: data on men with more than one follow-up biopsy. Epstein et al Am J Surg Pathol. 2001 Aug;25(8):1079-85 3) Rui Henrique, Carmen Jerónimo, Manuel R. Teixeira, et al., Epigenetic Heterogeneity of High-Grade Prostatic Intraepithelial Neoplasia: Clues for Clonal Progression in Prostate Carcinogenesis, Mol Cancer Res 2006;4:1-8 4) Trock, B. J., Brotzman, M. J., Mangold, L. A., Bigley, J. W., Epstein, J. I., McLeod, D., Klein, E. A., Jones, J. S., Wang, S., McAskill, T., Mehrotra, J., Raghavan, B. and Partin, A. W. (2011), Evaluation of GSTP1 and APC methylation as indicators for repeat biopsy in a high-risk cohort of men with negative initial prostate biopsies. BJU International. doi: 10.1111/j.1464-410X.2011.10718.x 5) Stewart et al., abstract LBA6, page 211, proceeding of the AUA Annual Meeting, May 2012, Atlanta, GA.