Agendia - International St. Gallen Expert Panel Highlights Importance of Molecular Subtyping - Gilde Healthcare

Agendia – International St. Gallen Expert Panel Highlights Importance of Molecular Subtyping

10. August 2011

Panel’s Recommendations Reinforce Clinical Value of Tests Such as BluePrint­­®

IRVINE, CA and AMSTERDAM, THE NETHERLANDS – Agendia, a commercial-stage molecular cancer diagnostics company, today announced that the 12th St. Gallen International Breast Cancer Conference (2011) Expert Panel’s recommendations highlight the value of molecular subtyping – classifying patients by the particular biological subtype of their tumor – in guiding treatment decisions for breast cancer patients. According to the panel,

“it is no longer tenable to consider breast cancer as a single disease”

and clinicians

“should consider cases within the various distinct subtypes in order to properly assess the relevant evidence and arrive at appropriate therapeutic advice.”

The panel’s updated guidelines, which are released on a semiannual basis, appear in the August 2011 issue of Annals of Oncology in an article titled “Expert Consensus on the Primary Therapy of Early Breast Cancer 2011” by Goldhirsch, et al (Annals of Oncology 22: 1736-1747, 2011).

The panel’s recommendations support the clinical value of Agendia’s BluePrint assay, which, in combination with the company’s FDA-cleared MammaPrint® recurrence test, can accurately classify all patients as Basal, Luminal-A, Luminal-B, or ERBB2 (HER2) and help determine appropriate treatment. Both clinically available, MammaPrint and BluePrint are two components of Agendia’s Symphony™ suite of breast cancer treatment products, a comprehensive collection of genetic assays that help address complex treatment decisions for any type and stage of breast cancer.

The panel also recognized that MammaPrint provided such accurate prognoses that patients and physicians may decide that chemotherapy is not required. MammaPrint identifies patients’ risk of metastasis, placing them into one of just two groups, high risk and low risk. Women in the low risk group are able to be treated effectively and safely without undergoing chemotherapy and its side effects.

“These recommendations reinforce what Agendia has known for some time – that molecular subtyping is an invaluable component of the treatment decision process in breast cancer,”

said Dr. Bernhard Sixt, CEO and Cofounder of Agendia.

“Along with MammaPrint’s proven prognostic ability to classify breast cancer patients according to recurrence risk, BluePrint and Symphony’s other tests offer a very powerful set of tools to help physicians eliminate uncertainty and make better treatment decisions.”

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 www.agendia.com.

For further information, please contact:

Ricochet Public Relations
Valerie Carter
Tel: +1 202 316 0143
E-mail: vcarter@ricochetpr.com

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