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Agendia Earns ISO Certification for Facilities in Amsterdam and Irvine
Date:8/20/2012

ISO 13485 is to harmonize regulatory requirements for quality management systems globally and includes an emphasis on process control and effectiveness for; design, development, manufacture, risk management, and distribution of related medical services.

About Agendia:
Agendia is a leading molecular diagnostic company that develops and markets genomic-based 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, ensuring 100% definitive results for cancer patients.  Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint­­, a molecular subtyping assay, TargetPrint®, an ER/PR/HER2 expression assay, and TheraPrint®, an alternative therapy selection assay. 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, please visit www.agendia.com.

For further information, please contact:

Post+Beam
Melissa Hurley
Tel: +1 646 442 2773
E-mail: hurley@postandbeam.is


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SOURCE Agendia
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