LONDON - October 25, 2007 - The 2007 Frost & Sullivan European Product Innovation Award in the field of biomarker-based breast cancer diagnostics is presented to Netherlands-based Agendia BV, for its new method of translating a breast cancer prognosis microarray signature into a high-throughput diagnostic test called MammaPrint®.

Agendia’s product offering employs a robust custom-made microarray that efficiently analyses gene expression profiles of 70 known cancer genes and determines the probability of breast cancer recurring within five to ten years after initial determination.

“The MammaPrint® breast cancer recurrence test has been proven to outperform clinical parameters in predicting distant metastasis in breast cancer patients,” notes Frost & Sullivan Research Analyst Sandhya Kamath. “Based on a platform of sophisticated microarray expression profiling and proprietary algorithms to interpret gene signatures, MammaPrint® categorizes breast cancer patients based on prognosis.”

The MammaPrint® test measures the activity levels of each of the 70 genes in a sample (surgically excised breast tumor) and then, based on a specific algorithm, classifies breast cancer patients into different groups based on their risk for developing distant metastasis. These results, in conjunction with other clinical information and laboratory tests, assists physicians in identifying the most suitable therapy and provide patients with opportunities for better treatment.

Agendia was granted the ISO 17025 accreditation and CE registration for the MammaPrint® in 2005.  In February 2007, Agendia became the first company to receive a 510K clearance from the US FDA for it’s MammaPrint® breast cancer prognosis test on fresh or fresh-frozen tumour tissue under the newly defined in vitro diagnostics multivariate index assay (IVDMIA) regulations.

“In June 2007, Agendia received a second clearance from the FDA for its MammaPrint® sampling and room temperature shipping procedure, using a RNA preserving solution (RNARetain®),” adds Ms. Kamath. “The use of RNARetain in combination with MammaPrint® is even simpler than the commonly used formalin fixation and paraffin embedding (FFPE) method and is specifically designed and validated to preserve RNA integrity.”

To further its commercialisation and distribution efforts, Agendia has formed key strategic partnerships with companies such as Medvet Science (Australia), Ferrer in Code (Spain), Teva & Tuteur (Argentina and Paraguay), Opaldia Ltd. (the United Kingdom), Gene Care (South Africa) and Makro (Turkey). 

Moreover, Agendia collaborates with prominent academic institutions and companies - Erasmus Medical Center in Rotterdam, the Netherlands Cancer Institute in Amsterdam and Massachusetts General Hospital in Boston, among others - to maintain its cutting-edge research.

“Agendia is truly one of the most promising companies endeavoring to translate gene expression analysis into clinical tests,” concludes Ms. Kamath. “In addition to MammaPrint®, the company has two more innovative diagnostic tests in the market: the CupPrint, a test that determines the tissue type of a tumor of unknown origin, and the DiscoverPrint, which predicts responders and non-responders to experimental new cancer drugs by analyzing RNA from tumors treated with these drugs with DNA microarrays.”

The Frost & Sullivan Award for Product Innovation is presented each year to the company that has demonstrated excellence in new products and technologies within its industry. The recipient company has shown innovation by launching a broad line of emerging products and technologies.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.  Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

About Agendia BV

Agendia, located in Amsterdam, the Netherlands, is a world leader in gene expression analysis-based diagnostics with three products on the market. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia was the first company to commercialize a prognostic test - MammaPrint® - that predicts the risk of breast cancer recurrence. Its second microarray product, CupPrint®**, is a diagnostic test to identify the origin of a metastasis in a cancer type called “Cancer of Unknown Primary”. Agendia recently also presented its new colon cancer prognosis profile, ColoPrint®, which is currently undergoing further validation.

Agendia maintains close ties with several leading academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharma companies focusing on development of highly effective personalized drugs in the area of oncology. http://www.agendia.com

* RNARetain® is a trademark of Asuragen Inc.
** CupPrint® is based on a license to the TUO database of AviaraDx Inc.

Contact Information:
Agendia: Bernhard Sixt, CEO, 0031 20 512 9161, Bernhard.Sixt@agendia.com

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Contact Information:
Frost & Sullivan: Ciara Jamie Connolly, Senior Events & Promotions Executive, 0044 207 915 7868, Ciara.Connolly@frost.com