ConfirmMDx is the Most Significant Predictor of Prostate Cancer Detection on Repeat Biopsy
Independently published clinical studies have shown that for men who have received a negative prostate biopsy result, ConfirmMDx is the single most significant predictor of patient outcome among all currently available clinical factors, such as age, PSA level, and DRE results.1,2 The ConfirmMDx test examines prostate biopsy tissue at the DNA level to detect cancer-related changes in cells adjacent to cancer foci (field effect) that cannot be seen under a microscope. If these changes are detected, the patient is at higher risk for clinically significant prostate cancer (CS PCa) and may benefit from earlier follow up and early detection.
ConfirmMDx Provides Actionable Results
If the test is positive, the patient is at increased risk for CS PCa and may benefit from earlier follow-up. If the test is negative, the patient has a very low risk for CS PCa and may continue with standard follow-up.
- Van Neste L, Partin AW, Stewart GD, Epstein JI, Harrison DJ, and Van Criekinge W. Risk Score Predicts High-Grade Prostate Cancer in DNA-Methylation Positive, Histopathologically Negative Biopsies. The Prostate. 2016 Sep;176(12):1078-87.
- Partin AW, Van Neste L, Klein EA, Marks LS, Gee JR, Troyer DA, Rieger-Christ K, Jones JS, Magi-Galluzzi C, Mangold LA, Track 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. The Joumal of Urology. 2014 Oct;192(4):1081-7.
Naughton CK, et al. A prospective randomized trial comparing 6 versus 12 prostate biopsy cores: impact on cancer detection. J Urol 2000; 164: 388.
Siegel RL, et al. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5. PMID: 25559415.
i When compared to standard clinical risk factors.
MDxHealth is regulated under the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) as an accredited laboratory to perform high complexity clinical testing. This test was developed, and its performance characteristics determined by MDxHealth. It has not been cleared or approved by the US Food and Drug Administration. The FDA has determined such clearance or approval is not necessary.