Approximately 700,000 American men receive a negative prostate biopsy result; however approximately 25%3 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.
The test is conducted on the biopsy material that was obtained at the time of your ultrasound and prostate biopsy. No additional invasive tests are required. This test is also covered by most insurance companies including Medicare.
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.\
Bottom Line: If you have an elevated PSA level and you have had a negative prostate biopsy, then consider this additional test which may help rule out cancer or confirm early prostate cancer when it is treatable and can be cured.