Gen-Probe Initiates US Clinical Study For PROGENSA PCA3 Assay

Gen-Probe has initiated a clinical trial intended to secure US regulatory approval of its PROGENSA PCA3 assay, a new molecular test that may help to determine the need for a repeat prostate biopsy.

The clinical study of the PROGENSA PCA3 assay is expected to conclude in less than a year, after which Gen-Probe plans to submit a Premarket Approval Application (PMA) to the FDA.

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.

Eric Lai, senior vice president of research and development at Gen-Probe, said: 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. In addition, this is an important step forward in our efforts to maximize the economic value of our oncology strategy.