Gen-Probe Incorporated (Gen-Probe), a developer of nucleic acid tests to diagnose human diseases and screen donated human blood, has initiated a clinical trial for its PROGENSA PCA3 assay. The trial is conducted to obtain the US approval for this assay that may help determine the need for a repeat prostate biopsy.
Based on the results of our extensive clinical research studies and our European commercial experience, we believe that our PROGENSA PCA3 assay can help predict the risk of a positive follow-up biopsy, thereby improving patient care, said Eric Lai, PhD, Gen-Probe’s senior vice president of research and development.
The clinical study of the PROGENSA PCA3 assay is expected to conclude in less than a year, after which Gen-Probe intends to submit a Premarket Approval Application (PMA) to the US Food and Drug Administration. The Company anticipates the trial will enroll approximately 500 men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites.
Data from more than 20 publications suggest that the PROGENSA PCA3 assay, when used in conjunction with other patient information, may help address some of the well-known challenges urologists face when identifying prostate cancer, such as minimizing unnecessary biopsies.