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Agendia Test for Molecular Subtyping of Breast Cancer Shown to Better Identify Risk of Disease Recurrence

Press releases may be edited for formatting or style | March 11, 2014

They concluded that oncologists who relied exclusively on clinical pathology subtyping with IHC/FISH would have misclassified a substantial number of these patients, potentially leading to overtreatment with chemotherapy in some cases and undertreatment in others. The research was first presented at the 2013 San Antonio Breast Cancer Symposium (SABCS).

MammaPrint uncovers more treatable biology, providing invaluable clinical information about an individual woman's breast cancer and whether she is likely to experience a recurrence of the disease. The test delivers definitive High Risk or Low Risk information about the risk of recurrence, with no ambiguous "intermediate" results. It is the only assay providing risk recurrence information that is based on prospective trials including peer-reviewed patient outcome data (the RASTER study).

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The first FDA-cleared test of its kind, MammaPrint is performed as part of Agendia's Symphony® test panel, which also includes BluePrint, the most widely available test providing molecular subtyping of individual breast cancers. The Agendia tests have substantial insurance coverage encompassing an estimated 182 million lives and including coverage by Medicare and regional and national insurers.

The scientific poster presented at MBCC was titled "Molecular subtypes of cases discordant between risk classification assays in patients with ER+, N0-N1 breast cancer."

About Agendia:

Agendia is a leading molecular diagnostic company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome. Symphony includes MammaPrint, the first FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint­[<00AD>][<00AD>]­[<00AD>][<00AD>], a molecular subtyping assay, and TargetPrint®, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay backed by peer-reviewed, prospective outcome data proven to uncover more treatable biology. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other, less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials. For more information, visit www.agendia.com.

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