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Agendia Raises €25 Million and Receives Second FDA Clearance

Agendia Raises €25 Million and Receives Second FDA Clearance

Agendia Raises €25 Million and Receives Second FDA Clearance

Agendia Raises €25 Million and Receives Second FDA Clearance

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Agendia BV. has announced that it has raised €25 million ($34 M) in a fourth financing round. ING, one of the largest bank-insurers, becomes a shareholder of Agendia.

Agendia is a molecular diagnostics company that develops and provides highly cancer diagnostic tests for pathologists, oncologists, clinicians and patients through its central service laboratory.

In February of 2007, Agendia was the first company to receive a 510K clearance from the US FDA for it’s MammaPrint® breast cancer prognosis test on fresh-frozen tumor tissue under the newly defined IVDMIA regulations (in vitro diagnostics multivariate index assay).

In June of this year Agendia received a second clearance from the FDA for its MammaPrint® sampling and room temperature shipping procedure, using a RNA preserving solution (RNARetain®). 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.

Agendia’s Laura van 't Veer says: ”Implementing new technologies under the IVDMIA regulations does not allow for regulatory shortcuts. Clinicians are conservative as they need to make sure that patients are not harmed. FDA review is vital for the smooth implementation and sustainable success of molecular diagnostics”.

"We are honored that ING has joined our investors group as a powerful and substantial shareholder in Agendia and pleased that our current investors Van Herk Biotech B.V., Gilde Healthcare Partners B.V. and Global Life Science Ventures have also participated. This supports Agendia’s vision of exploiting the enormous potential of gene expression profiling to improve treatment decisions in cancer," says Bernhard Sixt Ph.D., Chief Executive Officer of Agendia.

"We are currently moving forward with the introduction of the test in the US, while also expanding our activities in the EU and Asia. The recent FDA approvals in combination with this financing round allows Agendia to strengthen its position as a world leader in personalized medicine,” said Sixt.