Agendia's Breast Cancer Recurrence Test MammaPrint Included - Gilde Healthcare

Agendia’s Breast Cancer Recurrence Test MammaPrint Included

June 23, 2009

International Expert Panel Recommends Use of Multigene Profiling Assays and Finds Intermediate Scores Lack Clinical Utility

HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS – Agendia, a world leader in molecular cancer diagnostics, today announced the inclusion of its breast cancer recurrence test MammaPrint in St. Gallen’s 2009 International Expert Consensus on the primary therapy of early breast cancer. The recommendations have been published online in the Annals of Oncology and will appear in the August print edition.

The St. Gallen expert panel consists of key opinion leaders from across Europe (53%), the United States (33%), and rest of the world (14%). In the recently published article highlighting the 2009 recommendations, the panelists emphasize that

“in an important change from the previous St. Gallen conference … the Panel supported the use of a validated multigene-profiling assay, if readily available, as an adjunct to high-quality phenotyping of breast cancer in cases in which the indication for adjuvant chemotherapy remained uncertain.”

In addition, the panel cautioned that so-called intermediate scores are not useful in clinical decision making. Currently, MammaPrint is the only breast cancer recurrence assay available that accurately yields a binary result, without an intermediate group, addressing the panel’s recommendations. The FDA-cleared assay is always clinically useful and indicates whether a patient is at low or high risk for metastasis and the resulting clarity is vital in helping physicians personalize treatment options.

“St. Gallen’s guideline inclusion is a key step in further establishing MammaPrint as a standard of care. It also supports our commitment to upholding rigorous standards of quality and efficacy,”

said Dr. Bernhard Sixt, Agendia’s President and Chief Executive Officer.

“With MammaPrint we aim to provide breast cancer patients and their physicians with definitive answers to crucial treatment questions.”

In addition to MammaPrint, the company also offers TargetPrint to further improve breast cancer treatment options. TargetPrint quantitatively determines the gene expression levels of HER2neu, estrogen and progesterone receptors. Ongoing research and development efforts continue to augment Agendia’s ability to accurately predict breast cancer recurrence, and help physicians tailor individual treatment plans to their patients.

For online access to the Annals of Oncology: http://annonc.oxfordjournals.org/cgi/content/full/mdp322v1

About Agendia

Agendia is at the forefront of the personalized medicine revolution, striving to bring more effective, individualized treatment within reach of patients. Building on a cutting edge genomics platform for tumor gene expression profiling, the company’s tests aim to help physicians more accurately tailor cancer therapy. The company markets four products, with several new genomic tests in development. Agendia collaborates with pharmaceutical companies in the development of highly effective personalized drugs in the area of oncology and was awarded the 2008 North American Oncology Clinical Diagnostics Healthcare Innovation Award by Frost & Sullivan. Agendia is based in Huntington Beach, California, and in Amsterdam, The Netherlands. For more information please visit www.agendia.com.

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