Advisory Panel Recommends Approval of Vysis HER2 Test

December 1, 1998

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, 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.