This analysis formed the basis of HercepTest's approval as an aid in the selection of patients for Herceptin therapy. More important, he presented data indicating Herceptin benefit is restricted to those patients demonstrating gene amplification. All of the responses were in the FISH-positive group. These data support using FISH for primary testing. A tiered-testing strategy is not optimal, Dr. Mass says.
Amplified patients are the group demonstrating benefit from the drug.
People who have seen those slides say they have a very high background. So a comparison of that assay with FISH does not necessarily relate to the assay we are using today.