Healthcare Industry News:  MammaPrint 

Diagnostics FDA

 News Release - February 6, 2007

Agendia Receives U.S. FDA Clearance for MammaPrint Breast Cancer Diagnostic Test

First multi-gene expression test to receive regulatory clearance

AMSTERDAM, The Netherlands, Feb. 6 (HSMN NewsFeed) -- Agendia announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's MammaPrint breast cancer diagnostic test. MammaPrint is a gene expression profiling service to assess the risk of recurrence in breast cancer patients. MammaPrint represents a U.S. regulatory milestone as the first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the FDA, and is the agency's first step toward standardizing these multi-gene expression tests.

"Today's FDA clearance of MammaPrint is a milestone for patient care and safety," said Dr. Bernhard Sixt, Chief Executive Officer at Agendia. "As the first test of its kind cleared by the FDA, this type of regulatory review benefits breast cancer patients and provides regulatory clarity to the medical community. At present, MammaPrint is the first cleared IVDMIA which can be marketed in the US in compliance with these new FDA guidelines. We are exploring ways to make this product available in the US."

"We are pleased about today's FDA announcement as it signifies an important first step in standardizing IVDMIAs to ensure a safe and welcomed advancement in cancer diagnostics," said Diane Blum, MSW, Executive Director of CancerCare.

This week, the FDA will hold a public hearing to discuss draft guidance developed by the agency regarding IVDMIAs. The FDA intends to regulate multi- gene molecular diagnostics tests that meet specific criteria to ensure maximum safety and efficacy, as well as to ensure IVDMIA results can be easily interpreted by physicians.

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 maintains close ties with several leading European academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharmaceutical companies focusing on development of highly effective personalized drugs in the area of oncology.

More information about Agendia BV and MammaPrint is available at www.agendia.com


Source: Agendia

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