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Agendia Preparing to Scale Up to Deliver Array-based Gene-Expression Tests Globally

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Equipped with “double-digit” million-dollar funding from a recent Series A round, and about to embark on an EU-funded clinical trial involving 5,000 patients, Amsterdam microarray diagnostics startup Agendia is gearing up to deliver gene expression-based tests worldwide.

A web site that will allow doctors worldwide to order the test online is expected to go up this week at www.agendia.com. Oncologists send in tumor samples using a shipping procedure devised by Agendia and receive results within 10 business days.

The test is priced at €1,650 ($1,962), a “penetration pricing strategy,” according to Bernhard Sixt, Agendia’s chief executive officer. In the Netherlands, this cost is currently reimbursed on a trial basis through the healthcare system.

Also, Agendia is in the process of ramping up its facility to handle up to 5,000 samples per month, tripling its current capacity. By the end of the year, the company wants to increase its headcount to 30.

In February, the 14-person company launched its first microarray-based test — MammaPrint — which predicts breast cancer metastasis. Based on research from the Netherlands Cancer Institute (NKI) that was published in the New England Journal of Medicine and in Nature in 2002, the test measures the expression of 70 genes in breast tumors. Depending on the expression profile, the test classifies women into “low risk” and “high risk” for developing metastases within 10 years.

MammaPrint is based on Agilent’s microarray platform, using custom-made arrays with more than 1,000 control probes for standardization, in addition to the 70 test genes.

Each patient sample is tested in duplicate, and every fifth test runs a standardized control sample to assure consistent quality.

“The biggest hurdle to introducing a new technology into a clinical setting is quality,” said Bernhard Sixt. “Quality, quality, quality, and quality.”

Clinical validation, meanwhile, is still ongoing: Agendia is participating in a 5,000 patient trial in the US that is currently in its pilot stage. It will also participate in a EU-funded trial, called Mindact, that will involve 5,000 patients from Europe and Latin America and will start in the fall of 2005.

Mindact is the first project of Trans-Big, a translational research collaboration that will be funded in part with approximately €7 million ($8.4 million) from the EU’s 6th Framework Program. It will involve 39 partners from 21 European and Latin American countries, including Agendia.

The trial will compare a traditional breast cancer evaluation method based on histophathological and clinical criteria recommended by international guidelines to Agendia’s MammaPrint test.

Additional funding is expected from pharmaceutical and biotech companies, grants, and cancer centers, said Carolyn Straehle, managing director of Breast International Group of Belgium.

MammaPrint will eventually help doctors, who currently rely on clinical criteria, in making treatment decisions, Sixt said.

Currently, the test is only used on stage I and II lymph node negative breast tumors, and only to identify patients who are undertreated, or to help with difficult cases. “Compared to the current clinical guidelines, our test is significantly better,” Sixt said. As validation data comes in, he said, it might also be used in the future to determine patients who are overtreated.

At the moment, Agendia provides the test as a service through its own laboratory, and has no specific plans to sell or license it.

For now, Agendia has no plans to move away from the microarray platform. “Maybe in the long-term future, the platform has to develop somehow,” said Sixt, noting that Agendia is collaborating with Agilent to develop the technology. “For higher throughput, the platform is not really suitable but I think Agilent has very good plans to go along with development,” he said.

Agendia is currently in discussions with distributors in several countries, but marketing activities are just starting in Europe, Sixt said. “We are not too pushy because… requests are already coming in.”

Within the next year, Agendia plans to launch three additional profiles for yet undisclosed cancers, also based on results from NKI researchers. Five years from now, Sixt said, the company hopes to have “three digit million euros per year” in revenues.

Agendia was founded last summer by researchers from the NKI. The company’s Series A funding was led by Gilde Investment Management, and included Global Life Science Ventures and AXA Private Equity.

—JK

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