Nearly one million men undergo prostate biopsy yearly in the US. 750,000 (3 in 4) of these biopsies are histologically found to be negative for evidence of prostate cancer by microscopic analysis. Other data suggest that of these 750,000 negative biopsies, 25% (187,000) actually have cancer in the prostate that the initial biopsy might have missed. A new tissue assay (made by ConfirmMDx)
|Jonathan I. Epstein, MD|
|Alan W. Partin, MD, PhD|
"The DOCUMENT study validates the three-gene epigenetic assay as a better predictor of risk for the presence of occult cancer than any other factor in the clinic today. Results from this study provide further clinical evidence that the epigenetic test delivers actionable information to help guide urologists on the decision for repeat prostate biopsy."
"DOCUMENT was a pivotal validation study, demonstrating that the test's high negative predictive value and odds ratio are robust and reproducible in different cohorts of patients," stated Dr. Epstein. "The importance of this blinded, multicentered study is that it validated the performance of the test using predetermined analytical cutoff values in a population of U.S. patients undergoing routine PSA screening for prostate cancer."
The entire manuscript appears in the April 18, 2014 Edition of the Journal of Urology. Click here of follow the link below to read the entire manuscript.
Partin AW, Van Neste L, Klein EA, Marks LS, Gee JR, Troyer DA, Rieger-Christ K, Jones JS, Magi-Galluzzi C, Mangold LA, Trock BJ, Lance RS, Bigley JW, Van Criekinge W, Epstein JI. Clinical Validation of an Epigenetic Assay to Predict Negative Histopathological Results in Repeat Prostate Biopsies. J Urol. 2014 Apr 18. pii: S0022-5347(14)03341-2. doi: 10.1016/j.juro.2014.04.013.
 Stewart GD, Van Neste L, Delvenne P, Delrée P, Delga A, McNeill SA, O'Donnell M, Clark J, Van Criekinge W, Bigley J, Harrison DJ. Clinical utility of an epigenetic assay to detect occult prostate cancer in histopathologically negative biopsies: results of the MATLOC study. J Urol. 2013 Mar;189(3):1110-6. doi: 10.1016/j.juro.2012.08.219. Epub 2012 Oct 8.
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