Gen-Probe launched its PCA3 assay, a new prostate cancer-specific molecular diagnostic test in Europe.
The PCA3 gene-based test detects the overexpression of PCA3 mRNA in urine. Studies have shown that, in greater than 95% of prostate cancer cases, PCA3 is 60- to 100-fold over-expressed in prostate cancer cells compared to normal cells, indicating that PCA3 may be a useful biomarker for prostate cancer.
Preliminary data show that the PCA3 assay is more specific to prostate cancer than the traditional serum prostate specific antigen (PSA) test, thus decreasing the likelihood of false positive results. PSA is produced by both cancerous and noncancerous prostate cells. Noncancerous conditions, such as BPH, can therefore cause elevated serum PSA levels that must be investigated, resulting in unnecessary medical procedures and patient anxiety.
"Only 25 to 30 percent of men who have a biopsy due to elevated PSA levels actually have prostate cancer, therefore the majority of elevated PSA tests are the result of noncancerous conditions," said Mark Emberton, M.D., senior lecturer in oncological urology of the Institute of Urology and Nephrology at University College Hospital in London.