Gen-Probe announced that the Company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its PROGENSA® PCA3 assay, a new molecular test that may help determine the need for repeat biopsies in men suspected of having prostate cancer.
"Based on the results of our US clinical study, data from numerous peer-reviewed publications, and our European commercial experience, we believe the PROGENSA PCA3 assay can help determine the need for repeat prostate biopsies, thereby improving patient care," said Carl Hull, Gen-Probe's president and chief executive officer. "In addition, this regulatory submission represents the second of four that we expect to complete in the United States this year. Together, these new products will start an important new sales growth cycle for the Company."
Gen-Probe is seeking FDA approval to use the PROGENSA PCA3 assay to test urine samples from men who previously have had a negative prostate biopsy. In support of this objective, the Company conducted a prospective, multicenter clinical study of the assay that enrolled 507 men. The trial began in August of 2009 and concluded in May of 2010. Gen-Probe intends to present the results of the study at a future medical meeting.
The FDA has formally filed Gen-Probe's PMA, and has advised the Company that a meeting of the Medical Devices Advisory Committee's Immunology Panel will be required to support approval of the PMA. No date for this meeting has been set.