ARTICLE | Clinical News

Progensa PCA3 assay regulatory update

September 27, 2010 7:00 AM UTC

FDA accepted for review a PMA from Gen-Probe for the Progensa PCA3 assay to aid in determining the need for a repeat biopsy in men suspected of having prostate cancer. According to the company, the agency said the Medical Devices Advisory Committee's Immunology Panel will meet to discuss the application. A date for the meeting has not yet been set. ...