BioWorld International Correspondent

Agendia BV raised €25 million (US$34.1 million) in a Series D round to fund the commercial roll-out of its FDA-approved MammaPrint breast cancer prognosis test and to continue development of its pipeline of other cancer tests based on gene expression profiling of tumor tissues.

The Amsterdam, the Netherlands-based company has not disclosed the total funding it has received to date, but the new round "should take us to profitability," CEO Bernhard Sixt told BioWorld International. The company is not disclosing its valuation either, but it is now a "significant" three-digit, hundred million Euro sum, he said. "It's not €101 million."

Agendia's tests are based on research linking clinical outcomes to the genetic signatures of various tumor types. Its lead product, MammaPrint, measures the expression levels of around 70 different genes and helps clinicians to determine whether or not a tumor is likely to metastasize. It can allow patients to avoid undergoing chemotherapy unnecessarily.

The test gained FDA approval under newly defined in vitro diagnostics multivariate index assay (IVDMIA) regulations in February. This approval applied to freshly frozen samples, however, and Agendia has since obtained a second approval, based on the use of RNARretain, a solution it licensed from Austin-based, Asuragen Inc. This preserves nucleic acid profiles at room temperature and therefore removes the "logistical nightmare" of having to ship frozen samples, Sixt said.

Agendia is selling MammaPrint in Europe, but has not yet finalized a partnership to commercialize it in the U.S. "The plan would be to do this as soon as possible of course," Sixt said. "We have some revenues - we are already into seven digits - but that's insignificant compared to what we want to do." The U.S. will be its main focus, as its single biggest market.

The company is also marketing a second test in Europe, CupPrint, which is designed to identify the primary tumor in patients with Cancer of Unknown Primary. ColoPrint, which applies genomic profiling to II and stage III colon cancers to predict the likelihood of recurrence, is undergoing validation and the company expects a European launch during 2008. FDA approval should follow around 12 months later.

At that point, the company will be well on its way to realizing its ambition, which involves shedding the biotechnology tag. "We want to become a molecular diagnostics company," Sixt said. "The perception of risk is a different one."

ING Group N.V. led the round. Existing investors Van Herk Biotech B.V., Gilde Healthcare Partners B.V. and Global Life Science Ventures invoked pre-emption rights to participate.