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Agendia to Invest New VC Cash in R&D; Firm Begins Talks with US FDA for MammaPrint Dx

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Dutch biotech Agendia last week closed a third round of financing with several European backers for an undisclosed amount, and is now in the thick of plans to seek regulatory approval for its MammaPrint test in the US.

Agendia said it has concluded a third financing round, led by Gilde Healthcare and the Van Herk Group. Van Herk, Gilde, AXA Private Equity Venture Funds, Global Life Sciences Ventures, and the Netherlands Cancer Institute are Agendia's current investors.

CEO Bernhard Sixt said this week that the cash will help Agendia develop its late stage microarray-based diagnostics. In 2004, the company launched MammaPrint, a prognostic that uses a gene expression profile of 70 genes to predict the recurrence of breast cancer, and followed it a year later with CupPrint, a prognostic for cancer-of-unknown primary (see BAN 5/19/2004, BAN 2/9/2005).

Agendia will use some of the cash to "accelerate our scientific marketing efforts through educational events," Sixt told BioArray News. Part of the funds will also be funneled into R&D. "We will accelerate especially the development of new signatures into clinical tests and several of them are already very advanced," he said, adding that that Agendia hopes to broaden [its] breast cancer offering by "answering more clinical relevant questions for the disease."

"Who is at risk for distant metastases is only the start?" Sixt said. "Obviously our customers want to know much more and what are the consequences … of it," he said. He also said that Agendia is "expanding into new cancer types," but declined to name them.

Talking to the FDA

The MammaPrint currently has a technical accuracy higher than 97 percent in Agendia's labs, which were ISO 17025 accredited in 2005 (see BAN 9/7/2005). Sixt said that the company is now in "advanced talks" with the US Food and Drug Administration to begin selling the test in the country for clinical use. He declined to speculate on when MammaPrint could receive approval but said that Agendia has "done all [of its] homework and [is] in an excellent position" to pursue FDA clearance.

The acknowledgement of the FDA talks puts Agendia in line with other array-based diagnostics companies that have publicly stated their intention to seek FDA approval for a variety of tests, including Nanogen, PathWork Informatics, Spectral Genomics, Abbott Laboratories, and others (see BAN 1/6/2006).

Unlike many of its rivals seeking FDA gold, Agendia has offered its test for two years, both through its central facilities in Amsterdam and selected global centers, such as the Molecular Profiling Institute in Phoenix, which became the sole US provider of MammaPrint in December 2004 (see BAN 12/15/2004).

However, Sixt said that the company does not wish to rush the FDA submission process to be the next array-based diagnostic to join the market. New technologies which will have an impact on patients' lives need to prove their reliability first," Sixt said. He said that MammaPrint currently had a technical accuracy higher than 97 percent in Agendia's labs, which were ISO 17025 accredited in 2005 (see BAN 9/7/2005).

— Justin Petrone ([email protected])

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