NEW YORK (GenomeWeb News) – Gen-Probe announced today that its Progensa PCA3 assay has been cleared by the US Food and Drug Administration for sale and marketing in the US.
The urine-based assay is the first molecular test for help in determining whether men who have had previous negative biopsies need repeat biopsies, the San Diego firm said. FDA approval follows a clinical study conducted between August 2009 and May 2010 with 495 eligible men at 14 clinical sites. In the study, the assay had a negative predictive value of 90 percent.
Gen-Probe had hoped for FDA approval of the PCA3 assay by the end of 2011, but an agency panel delayed its review of the company's PMA submission during the summer in order to have additional time to review and respond to the submission.
Gen-Probe acquired the exclusive worldwide diagnostic rights to the PCA3 gene from DiagnoCure in late 2003.
Progensa PCA3 was previously CE marked in 2006 and was cleared for sale in Canada in August.
"When used in conjunction with other diagnostic information, our Progensa PCA3 assay provides clinically important information that helps physicians and their patients make better, more informed decisions about one of the most vexing problems in prostate cancer diagnosis," Carl Hull, Gen-Probe's chairman and CEO, said in a statement. During the firm's fourth-quarter earnings conference call this week, he had hinted that FDA approval of the assay was forthcoming.
"From a commercial perspective, this is the third of four potential US regulatory approvals that we expect to generate a significant new sales growth cycle for the company," he added. Hull did not identify the other tests, but in the past year FDA cleared the firm's Aptima HPV assay and Aptima Trichomonas vaginalis assay.
The firm is awaiting a decision from FDA on its submission for the Panther molecular diagnostic system.