Approximately 700,000 American men receive a negative prostate biopsy result; however approximately 25% of these results are false-negative and that is the man has prostate cancer but the biopsy was not able to discover or confirm the disease. Under the current standard of care, prostate biopsy procedures sample 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. ConfirmMDx for Prostate Cancer addresses the unmet medical need for a clinically effective diagnostic test to address this dilemma.
ConfirmMDx for Prostate Cancer is a test to help distinguish patients who have a true-negative biopsy from those who may have occult cancer. The test helps your doctor to rule-out prostate cancer and to make it possible to perform repeat biopsies.
ConfirmMDx is a sophisticated test that detects subtle changes in the DNA level in cells adjacent to cancer cells. This halo around a cancer lesion can be present despite having a normal appearance under the microscope.
The MDX aids in the identification of high-risk men who may need a repeat biopsy and potential treatment.
Bottom Line: Prostate cancer is the most common cancer in middle age and older men. It is the second most common cause of death in men with lung cancer being at the top of the list. A negative biopsy does not definitively rule out prostate cancer. The MDX helps men spare the need for unnecessary repeat biopsies.