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Agendia Successfully Completes Bi-Annual FDA Inspection
Date:10/3/2011

erations from top to bottom, including recordkeeping, personnel, sanitation and cleanliness, equipment, process validation and complaint handling. This meticulous inspection ensures the reliability and safety of Agendia's MammaPrint test, and protects patients.

About Agendia:

Agendia is a leading global commercial molecular diagnostic company that develops and markets genomic-based diagnostic products that improve the quality of life for cancer patients and simplifies complex treatment decisions for their physicians. Agendia's Symphony™ suite of breast cancer products is based on the analysis of hundreds of genes in a patient's breast and provides unprecedented biological insight to address complex treatment decisions. 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®, a therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo or hormonal therapy, and which patients do not require these treatments and can instead be treated with other less arduous and costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development based on its world-class genomic platform. The company also collaborates with pharmaceutical companies to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

Agendia was founded in 2003 as a spin-off of the Netherlands Cancer Institute and is based in Irvine, California, United States, and Amsterdam, the Netherlands. For more information, please visit http://www.agendia.com.


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Related biology technology :

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2. Agendias Breast Cancer Test MammaPrint(R) Standard of Care at Netherlands Cancer Institute - AVL
3. Agendia Appoints VP of Business Development
4. Agendia Publishes Direct Evidence That MammaPrint Predicts Benefit of Chemotherapy in Breast Cancer
5. Agendia Appoints Seasoned Diagnostics Executive Albert A. Luderer to Supervisory Board
6. Agendia Presents Data Supporting MammaPrints Predictive and Prognostic Power at 2009 St. Gallen Breast Cancer Conference
7. Agendia to Present at BioCenturys Future Leaders in the Biotech Industry Conference
8. Agendia to Present Multiple Predictive and Prognostic Studies on Breast and Colorectal Cancers at ASCO Annual Meeting
9. Agendia Opens CLIA-Registered U.S. Genomics Laboratory
10. Agendia Supports Genentechs Citizens Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards
11. Agendia Raises US $23 Million in Series E Financing
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