Agendia BV Raises €25 Million ($34M) and Receives Second FDA Clearance
Agendia is a molecular diagnostics company that develops and provides highly innovative 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 (RNARretain®**). The use of RNARretain 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 Gobal Life Sience 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”.
“ We are pleased to join existing investors in helping Agendia to implement molecular diagnostics and thus improving cancer treatment through personalized medicine”, says Ton Giesen of ING Corporate Investments. "With outstanding cancer research, Agendia is very well-positioned to lead the development of microarray-based diagnostics for cancer", says Aat van Herk. "We look forward to the launch of ColoPrint®, Agendia’s colon cancer prognosis test in the near future. With a broad pipeline of tests and personalized treatment solutions in various cancer types, Agendia is at the forefront of molecular cancer diagnostics”, says Pieter van der Meer of Gilde Healthcare.
About MammaPrint®
MammaPrint® is a prognostic DNA microarray-based in vitro diagnostic test that measures the activity of 70 genes to assess the risk of breast cancer recurrence. The information of this 70 gene profile, which has been published in premier journals such as Nature and the New England Journal of Medicine and has been independently validated in several studies, is superior to classical criteria such as the St. Gallen Consensus or NIH criteria in predicting outcome of disease.
About Agendia
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.
* CupPrint® is based on a license to the TUA database of AviaraDx
** RNARetain® is a trade mark of Asuragen Inc.
Contact Information:
Agendia: Bernhard Sixt, CEO at +31-20 512 9163