Frost & Sullivan Award Recognizes Agendia BV's Pioneering MammaPrint(R) in the Biomarker-based Breast Cancer Diagnostics Arena.(Company overview)

LONDON -- 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([R]).

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([R]) 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([R]) categorizes breast cancer patients based on prognosis."

The MammaPrint([R]) 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([R]) in 2005. In February 2007, Agendia became the first company to receive a 510K clearance from the US FDA for it's MammaPrint([R]) 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([R]) sampling and room temperature shipping procedure, using a RNA preserving solution (RNARetain([R]*))," adds Ms. Kamath. "The use of RNARetain in combination with MammaPrint([R]) 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).