Urine-based Prostate Cancer Assay Approved
FDA approved Gen-Probe’s first urine-based molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. The Progensa PCA3 test detects the presence of the prostate cancer gene 3 (PCA3). It is intended for use in conjunction with other patient information as an aid for deciding whether a repeat biopsy is necessary in men age 50 or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard-of-care.
Approval for Ventana’s Breast Cancer Assay
Ventana Medical Systems, Inc. received FDA approval for use of its Inform HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH) on the Ventana BenchMark Ultra automated slide staining platform in the U.S. Originally approved by the FDA in June 2011 for use with the BenchMark XT instrument, the HER2 Dual ISH assay is now approved for use on both Ventana BenchMark advanced staining platforms available in the U.S. The HER2 Dual ISH assay is designed to determine HER2gene status in breast cancer tissue as an aid in the assessment of patients who are being considered for treatment with Herceptin (trastuzumab).
Tryptase Assay Cleared
FDA cleared Thermo Fisher Scientific's ImmunoCAP Tryptase Assay for use on its Phadia Laboratory Systems line of automated laboratory instruments. The ImmunoCAP Tryptase assay works by measuring the level of tryptase released by mast cells into serum. The test is the first CLIA moderate complexity, fully-automated assay in the U.S. for mast cell tryptase. "Tryptase is one of the World Health Association criteria that is used for making a diagnosis of systemic mastocytosis, and with today's clearance, laboratories throughout the U.S. can now offer tryptase testing to their customers on fully automated CLIA Moderate Complexity instruments," said Jean Forcione, president of Thermo Fisher's immunodiagnostics business.