ConfirmMDx addresses prostate biopsy sampling error and the false-negative biopsy dilemma.

ConfirmMDx is an epigenetic analysis that helps distinguish those patients who have a truly negative biopsy from those who may be masking cancer.

The standard prostate biopsy only provides a limited evaluation because it samples a portion of the prostate at the time the samples are sent for testing. Prostate cancer may be present in one or more small tumors, and there is a risk that the biopsy needle may have missed it, resulting in false-negative results.

If a prostate biopsy has been performed with a negative result within the last 24 months, the remaining tissue samples from the previous prostate biopsy can be sent for ConfirmMDx testing. You do not need a repeat biopsy.

The ConfirmMDX test for prostate cancer addresses the concerns of a false-negative biopsy and helps the Urologist physician:

• DISCARD men who do not have prostate cancer from undergoing unnecessary repeat biopsies.
• INCLUDE men at high risk who may need to be re-biopsied and undergo possible treatment.

Independently published clinical studies have shown that for men who have received a negative prostate biopsy result, ConfirmMDx is the most significant predictor of patient outcome among all currently available clinical factors, such as age, PSA level and digital rectal examination results.

Men with an elevated or rising PSA level (≥ 4.0 ng/mL) and/or an abnormal digital rectal examination (DRE) are considered at high risk for cancer and are often referred for prostate biopsy to determine if prostate cancer is present. The standard prostate biopsy procedure takes 10 to 12 core samples, and histopathologic review by visual inspection under a microscope remains the gold standard for prostate cancer diagnosis. However, this scheme samples less than 1% of the entire prostate gland and results in limited histopathologic analysis. Sampling error is an inherent and well-documented problem, with false negative rates of prostate biopsy procedures reported as high as 25-35%.

ConfirmMDx is a well-validated epigenetic test that guides the detection of occult prostate cancer in a patient’s previously biopsied negative tissue.