Monogram and Dana-Farber Cancer Institute Initiate Evaluation of HERmark(TM) Breast Cancer Assay in Metastatic Bre...( SOUTH SAN FRANCISCO Calif. Sept. ...)

SOUTH SAN FRANCISCO, Calif., Sept. 23 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that it has initiated a study, in collaboration with the Dana-Farber Cancer Institute (DFCI), to evaluate Monogram's HERmark(TM) Breast Cancer Assay in metastatic breast cancer.

In the study, Monogram's proprietary HERmark assay will be used to analyze approximately 600 tissue samples from patients with breast cancer, approximately half of whom were eligible for treatment with Herceptin(R) 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, M.D., 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."

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