Cancer Treatment Today

ConfirmDx is a test that is attempting to fill the niche of assuring that negative biopsies are really negative. It is thought that as many as 25% of negative prostate biopsies are falsely negative. For this reason, how to improve accuracy of prostate biopsies is an important area of research.  ConfirmMDx for Prostate Cancer is an epigenetic assay that is claimed to help distinguish patients who have a true-negative biopsy from those who may have occult cancer.

The test is claimed to help 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 ConfirmMDx test (MDx Health) is a proprietary epigenetic assay that measures gene methylation associated with the presence of cancer. Results are intended to assist in determining which patients likely have a true negative biopsy, and which patients are at increased risk for occult cancer. Results may prevent necessary repeat biopsies in unaffected men, and triage higher risk patients for repeat biopsies and treatment, as needed.

The National Comprehensive Cancer Network (NCCN, 2018) Clinical Practice
Guidelines in Oncology for Prostate Cancer Early Detection state the following:, “Those patients with negative prostate biopsies should be followed with DRE
and PSA. Tests that improve specificity in the post-biopsy state-including
percent PSA, 4Kscore, PHI, PCA3, and ConfirmMDx-should be considered in
patients thought to be higher risk despite a negative prostate biopsy.”
o “Biomarkers that improve the specificity of detection are not, as yet,
recommended as firstline screening tests. However, there may be some patients
who meet PSA standard for consideration of prostate biopsy, but for whom the
patient and/or physician wish to further define the probability of high-grade
cancer. A percent free PSA <10%, PHI >35 or 4K score (which provides an
estimate of the probability of high-grade prostate cancer) are potentially
informative in patients who have never undergone biopsy or after a negative
biopsy; a PCA3 score >35 is potentially informative after a negative biopsy.”

Tests that improve specificity in the post-biopsy setting—including percent-free PSA, 4Kscore, PHI, PCA3, ConfirmMDx, ExoDx Prostate Test, MPS, and IsoPSA—should be considered in patients thought to be higher risk despite a negative prostate biopsy (PROSD-3).

On p. 24, NCCN discussed this test. It says: ” The panel believes that ConfirmMDx can be considered as an option for individuals contemplating repeat biopsy, because the assay may identify individuals at higher risk of prostate cancer diagnosis on repeat biopsy. ” As such, it should be considered m, medically necessary.

Van Neste L, Partin AW, Stewart GD, Epstein JI, Harrison DJ, Van Criekinge W.
Risk score predicts high-grade prostate cancer in DNA-methylation positive, histopathologically negative biopsies. The Prostate. 2016;76(12):1078-1087.

Partin AW, Vanc W, Trock BJ, et al. Clinical evaluation of an epigenetic assay to pr Transactions of the American
Clinical and Climatological Association. 2016;127:313-327

National Comprehensive Cancer Network (NCCN).Prostate Cancer Early Detection v.2.2024.