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News

Dana-Farber Cancer Institute collaborates with Monogram to evaulate breast cancer assay

Monogram Biosciences : 24 September, 2008  (Company News)
Monogram Biosciences has begun a study, in collaboration with the Dana-Farber Cancer Institute (DFCI), to evaluate Monogram's HERmark Breast Cancer Assay in metastatic breast cancer.
In the study, Monogram's proprietary HERmark Assay will be used to analyse approximately 600 tissue samples from patients with breast cancer, about half of whom were eligible for treatment with Herceptin on the basis of prior HER2 IHC and/or FISH testing. HERmark measurements of HER2 total protein and HER2 homodimer levels will be compared with the results of IHC and/or FISH testing as well as response to treatment with Herceptin.

'Results from prior studies in metastatic breast cancer have suggested that HERmark can identify subsets of patients with different responses to Herceptin even though they had all been previously assessed as 'HER2-positive' by IHC and/or FISH, tested centrally,' said Michael Bates, MD, Monogram's vice president of clinical research. 'The aim of this study is to test the hypothesis that HERmark selects patients for Herceptin treatment in the metastatic setting better than other currently available assays, as well as to test cutoff values that have been previously defined for HERmark. In addition, we will also measure HER3 expression levels in these tumors and see if they correlate with clinical outcomes in this cohort. The study will also provide enough tissue to facilitate testing of assays that are in advanced development at Monogram, including assays for HER1 expression, p95 expression, as well as heterodimers of HER2, such as HER2:HER3 and HER1:HER2.'

'The VeraTag technology represents a novel approach to the study of HER2- positive breast cancer by virtue of its ability to make accurate measurements of HER2 and its homodimer in actual breast tumours,' said Ian Krop, MD, PhD, assistant professor of medicine, Division of Medical Oncology at the Dana Farber Cancer Institute and principal investigator of the study. 'We look forward to working with Monogram on this study to try to develop a better understanding of the biology of HER2 positive breast cancer and the biomarkers that influence its clinical outcome.'
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