Advisory Panel Recommends Approval of Vysis HER2 Test
ROCKVILLE, Md-The FDA’s Hematology and Pathology Devices Panel voted unanimously to recommend that the agency grant conditional approval to Vysis, Inc.’s PathVysion HER-2 DNA Probe Kit to detect and quantify the HER2 gene in breast cancer patients. Based on Vysis’ fluorescence in situ hybridization (FISH) technology, the test for the HER2 gene was developed as a predictive marker for determining a patient’s response to doxorubicin-based chemotherapy.
ROCKVILLE, MdThe FDAs Hematology and Pathology Devices Panel voted unanimously to recommend that the agency grant conditional approval to Vysis, Inc.s PathVysion HER-2 DNA Probe Kit to detect and quantify the HER2 gene in breast cancer patients. Based on Vysis fluorescence in situ hybridization (FISH) technology, the test for the HER2 gene was developed as a predictive marker for determining a patients response to doxorubicin-based chemotherapy.
Treatment Combinations for HER2-Positive Breast Cancer
March 7th 2013As part of our coverage for the 30th Annual Miami Breast Cancer Conference, we bring you an interview with Dr. Mark Pegram, director of the breast cancer program at the Stanford Women’s Cancer Center and codirector of the molecular therapeutics program. Dr. Pegram will be discussing the potential for novel HER2 combination therapies at the conference.
