ConfirmMDx deals with the sampling error of the prostate biopsy and the dilemma of the biopsy false-negative
ConfirmMDx it is an epigenetic analysis that help to distinguish those patients who have a biopsy truly negative of those who might be hiding the cancer.
The prostate biopsy standard only provides a limited assessment that performs a sample of part of the prostate at the time of taking the samples that are sent to analysis. Prostate cancer can be present in one or more small tumors, and there is a risk that the needle of the biopsy may have missed, and so arise the results of false negative.
If you have undergone a prostate biopsy, with a negative result within the past 24 months you can send the remaining samples of tissue from the prostate biopsy prior to the test ConfirmMDx. You do not need to repeat the biopsy.
The test ConfirmMDX for prostate cancer addresses the concerns of a biopsy with a false negative, and helps the Urologist to:
- DISMISS men who do not have prostate cancer so that they do not undergo biopsies repeated and unnecessary.
- INCLUDE men with high-risk that may need to be repeated with a biopsy, and undergo a possible treatment.
Published clinical studies independently have shown that men who have received a negative prostate biopsy, ConfirmMDx is the predictor most significant result of the patient between all clinical factors that are currently available, such as age, PSA level, and the results of the digital rectal exam.
Men with a PSA level of high or increasing (≥ 4.0 ng / ml) and / or a digital rectal exam (DRE) is abnormal is considered to be at high risk of cancer and, often, they will drift to a prostate biopsy to determine whether prostate cancer. The standard procedure of prostate biopsy takes 10 to 12 samples central, and the review histopathologic by visual inspection under a microscope remains the gold standard for the diagnosis of prostate cancer. However, this scheme takes a sample of less than 1% of the prostate gland complete, and gives as a result a histopathological analysis limited. The sampling error is an inherent problem and well documented, with rates of false-negative procedures of prostate biopsy reported as high as 25-35%.
ConfirmMDx it is a test epigenetic well validated that guide the detection of prostate cancer hidden in the tissue-negative previously biopsied from a patient