• A new, high-sensitivity HER2 assay developed by Dr. Rimm's lab aims to improve the accuracy and sensitivity of HER2 testing, crucial for identifying patients who may benefit from ADCs.
• The assay utilizes immunofluorescence to measure HER2 antibody binding, offering a more quantitative approach compared to traditional methods, potentially increasing sensitivity by tenfold.
• Danaher's Beacons program supports the assay's development into a standardized product through collaboration with Leica Biosystems and a clinical trial in partnership with Cepheid.
• The clinical trial will assess both the new HER2 assay and Cepheid's STRAT4 assay, which measures HER2 RNA levels, to determine the optimal method for predicting ADC response in breast cancer patients.