Copenhagen,
Denmark. DakoCytomation now offers the HER2 FISH pharmDx(TM) test for use as an aid in identifying European
breast cancer patients eligible for Herceptin(TM) therapy.
Herceptin(TM), marketed by
Roche in Europe, is a targeted monoclonal antibody treatment for women with HER2-positive metastatic breast cancer. HER2 FISH pharmDx(TM) is a
fluorescence in situ hybridization (FISH) assay designed to quantitatively determine HER2 gene amplification in breast cancer tissue.
"We are pleased to offer a new tool to aid in assessing patients with metastatic breast cancer," said Jes ?stergaard, CEO of DakoCytomation. "This assay is a significant addition to our portfolio of pharmacodiagnostic products designed to help physicians identify the most appropriate targeted therapy."
HER2 FISH pharmDx(TM), which is not available in the United States, will compliment DakoCytomation's HercepTest(TM) - the first clinical test to help assess candidates for a specific targeted therapy. HercepTest is a slide-based assay that demonstrates levels of HER2 protein overexpression in patient samples. The new highly sensitive HER2 FISH pharmDx(TM) assay will provide additional clarification and ensure the most appropriate use of
Herceptin.
DakoCytomation also recently received
regulatory approval in both the United States and in
Switzerland for use of its EGFR pharmDx(TM) kit as an aid in identifying
colorectal cancer patients eligible for treatment with ERBITUX(TM) (cetuximab).