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Monogram and Dana-Farber Cancer Institute start HERmark study

This article was originally published in Clinica

Executive Summary

Monogram Biosciences has started a study of its HERmark assay in metastatic breast cancer, in collaboration with the Dana-Farber Cancer Institute in Boston. The test quantifies expression of the HER2 gene, identifying patients who respond to HER2-targeting therapies like Roche's Herceptin (trastuzumab). The trial will analyse 600 tissue samples – around half of which were from patients eligible for Herceptin treatment – and compare them with results of immunohistochemistry and/or fluorescence in situ hybridisation testing, the current standards for measuring HER2 levels. These are only semi-quantitative, South San Francisco, California-based Monogram says. The trial will also measure response to Herceptin treatment, as previous studies suggest that HERmark can identify subsets of patients likely to respond to the drug.

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