PCF-Funded Discovery Results in a New Diagnostic Test to Diagnose Prostate Cancer
February 15, 2012 -- The US Food and Drug Administration (FDA) approved today a urine-based molecular diagnostic test that aids clinical decision-making for repeat prostate biopsies in men who have had a previous negative biopsy. This new test called the PROGENSA® PCA3 (Prostate Cancer Antigen 3) assay, tests for levels of PCA3 in the urine of men immediately after a Digital Rectal Examination. This test will potentially aid faster and more efficient diagnosis of prostate cancer. PCA3, the compound that this test checks for, is a gene that is normally expressed only in the human prostate tissue and is highly overexpressed in prostate cancer. The product of this gene, a noncoding RNA is excreted in the urine of patients with prostate abnormalities.
The current standard for prostate cancer screening employs the Prostate Specific Antigen (PSA) test which is prostate-specific but not highly cancer-specific. In contrast, PCA3 testing is highly cancer-specific, with better positive and negative predictive values compared to PSA testing.
With partial research support from the Prostate Cancer Foundation to Dr. William Isaacs at Johns Hopkins University in 1998, a gifted young woman scientist, Dr. Marion Bussemakers, from Radboud Universiteit Nijmegen in Holland, published a seminal research paper titled “DD3: a new prostate-specific gene, highly overexpressed in prostate cancer.” The work was a collaboration between a Baltimore Maryland-Nijmegen Holland research team, including leaders Jack Schalken and Dr. Fritz De Bruyne, as research progressed. This initial funding impetus by PCF has put PCA3 testing to FDA approval.