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PCA3 ProfileR - FOR PATIENTS
PCA3 ProfileR™ is a urine-based assay used to provide physicians with information on patients who have an elevated serum PSA in conjunction with a previously negative prostate biopsy. PCA3 ProfileR aids the physician in determining the time interval for follow-up biopsy. The assay measures the expression of mRNA from the PCA3 gene. PCA3 is specific to the prostate and is significantly up-regulated (60-100 fold) in prostate cancer. PCA3 mRNA, along with the mRNA of PSA is measured quantitatively and examined as a ratio. High ratios have been shown to be indicative of prostate cancer. PCA3 ProfileR may provide assistance in follow-up treatment in patients with the "PSA Dilemma;" an elevated serum PSA and negative biopsy results.
To see abstracts concerning PCA3 click here.
To see the PCA3 ProfileR test protocol, click here.
This test was developed by GenProbe, Inc. and its performance characteristics determined by Molecular Profiling. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). This test is permitted for clinical purposes and should not be regarded as purely investigational or for research. Molecular Profiling is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. This test is believed to be a useful adjunct in the diagnosis of prostate cancer and useful in the prediction of positive biopsy. Decisions regarding care and treatment should not be based on a single test such as this test. Rather, decisions on care and treatment should be based on the independent medical judgment of the treating physician taking into consideration all available information concerning the patient's condition, including other pathological tests, in accordance with the standard of care in a given community.
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