A Medical Device Daily
AmeriPath (Palm Beach Gardens, Florida), a provider of physician-based anatomic pathology, and the Molecular Profiling Institute (MPI; Phoenix), a specialty reference lab, have introduced PCA3 ProfileR, a test that they say “for the first time provides a critical new diagnostic tool for prostate cancer.”
Until now, patients who showed elevated serum PSA (prostate-specific antigen) levels but had negative biopsy results were faced with a dilemma: Is the biopsy a false negative, or is the PSA elevated for reasons other than cancer?
The company said that the PCA3 ProfileR brings new clarity: “a positive result may indicate prostate cancer and the need for an additional biopsy; a negative result may suggest that a relatively longer time interval may be acceptable between biopsies.”
“PCA3 ProfileR offers urologists a way to determine repeat biopsy intervals for patients who continue to have a PSA greater than 4 ng/ml, but who have negative biopsies,” said Robert Penny, PhD, CEO of MPI. He said that the accuracy of PCA3 ProfileR is 70%, compared to 35% for serum PSA in the study population.
AmeriPath offers a comprehensive urologic disease management program focusing on prostate cancer, bladder cancer and kidney stone disease. MPI provides additional resources and testing to enable better disease management.