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New Releases: Apr 7, 2010

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Agendia last month launched BluePrint, an 80-gene signature breast cancer diagnostic that identifies the basal-like, luminal-like, and HER2 molecular subtypes in breast cancer tumors.

“Using BluePrint, we will research potentially different responses of therapies to biologically different subgroups together with our customers," Agendia Chief Medical Officer Richard Bender said in a statement. "In the future, we envision the clinical utility of a combination of BluePrint with MammaPrint’s original 70-gene panel."

The hypothesis for BluePrint was investigated in an initial cohort of 295 breast cancer patients whose tumors were separated into basal-type, luminal-type, and ERBB2-type breast cancers.

Researchers then compared the gene expression patterns of these groups to identify a set of 80 genes that distinguished the three cancers. Next, they validated the accuracy of the genes in 374 independent samples hybridized to 44k Agilent arrays. This resulted in 90 percent concordance between the molecular subtyping profile and the classification based on ER, PR and HER2/neu status.

This multi-gene profile was further validated against a publicly available dataset generated using Affymetrix arrays. In this validation effort, researchers found 79 percent concordance between the BluePrint profile and classification using ER, PR and HER2/neu receptor status.

BluePrint is the third breast cancer diagnostic in Agendia's portfolio, which includes MammaPrint, the first in vitro diagnostic multivariate index assay for breast cancer recurrence to be approved by the US Food and Drug Administration; and TargetPrint, a microarray-based gene expression test that provides quantitative assessment of a breast cancer patient’s estrogen receptor level, progesterone receptor level, and HER2/neu overexpression. TargetPrint is offered in conjunction with MammaPrint to provide doctors with a more in-depth molecular analysis of their patients' tumor.

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