BioWorld International Correspondent

Agendia BV closed a third funding round to advance development and marketing of its microarray-based cancer diagnostics. Total investment was not disclosed, but company CEO Bernhard Sixt told BioWorld International that it was more than $10 million.

The company raised a smaller, second round in October, but has taken on more finance now to exploit progress in clinical validation of its lead product, MammaPrint, a prognostic tool that predicts on the basis of an expression profile comprising 70 genes whether a woman newly diagnosed with breast cancer is likely to experience a recurrence. It stratifies patients more accurately than current criteria and spares about 20 percent from undergoing unnecessary chemotherapy.

"MammaPrint is significantly out-performing the Saint Gallen criteria, as well as other standards," Sixt said. Agendia's founders performed much of the underlying scientific work at the Netherlands Cancer Institute (NKI) in Amsterdam. (See BioWorld International, Aug. 27, 2003.)

A preliminary validation of the test, performed at five European cancer centers by an independent research consortium, has been accepted for publication in the Journal of the National Cancer Institute, Sixt said. The positive data also will enable a wider study, involving 6,000 patients, to commence in multiple centers. Some 250 were picked, Sixt said, from about 800 applicants.

"There was a huge interest internationally, but the centers had to pass significant quality hurdles," he said. The study is being conducted by the TransBIG consortium, which is partially funded by the European Commission's Sixth Framework Program. The trial sponsor is the Brussels-based European Organization for the Treatment and Research of Cancer (EORTC).

The product already has achieved registration under the CE marking scheme, which governs the sale of medical devices in the European Union, although sales remain modest at present. Five cancer centers in the U.S. also have access to the technology under an FDA investigational device exemption, which permits its use in clinical trials. "We are now talking about how to commercialize this on a broader basis," Sixt said.

Agendia, which is located in Amsterdam, currently performs all of the procedures required by the test. Its facility, Sixt said, is one of the few laboratories with ISO 17025 quality accreditation. "We have this overkill of quality because we want to concentrate on talking about clinical utility rather than test quality issues," he said. Eventually, the company aims to capture the test in a kit that can be used in clinical settings.

The company also is commercializing a second product, CupPrint, which identifies the primary tumor in cancers of unknown primary (CUP) - between 2 percent and 7 percent of all cancer cases, Sixt said, depending on the sophistication of the pathology employed. CUP has a poor prognosis, but about 15 percent of patients can have improved survival if the primary tumor is recognized sufficiently quickly.

"The distal metastases react to the same treatment as the primary tumor," Sixt said. It can identify 39 clinically defined tumor types at present, based on a readout of 800 genes.

Agendia will launch three more products over the next six months, Sixt said, two of which will provide further diagnostic information in breast cancer. The third will address a different form of cancer.

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