Dutch cancer diagnostic startup Agendia has begun ramping up its marketing arm and lab capacity to support a recently launched breast cancer diagnostic, the company said recently.
Flush from a multi-million-dollar private-equity round of financing and a successful — if quiet — release of the test in February, Agendia also aims at developing and introducing a modest suite of array-based differential diagnostics within the next year.
In February, the company launched its first test, which was designed to predict breast cancer metastasis. The test, which is based on research from the Netherlands Cancer Institute that appeared in the New England Journal of Medicine and Nature, relies on microarrays to measure the expression of 70 genes in breast tumors. Marc van de Vijver and Laura van ‘T Veer co-authored those papers.
[The NCI, together with Rosetta Inpharmatics, a wholly owned subsidiary of Merck, performed this research using Agilent arrays and tissue samples.] Agendia uses this expression profile to classify women at either “low risk” or “high risk” for developing metastases within 10 years.
Clinical validation is still ongoing. Agendia said it is participating in a 5,000-patient pilot trial in the United States, and will be part of a 5,000-patient European trial slated to begin this summer.
The breast cancer test will help doctors who currently rely on clinical guidelines such as tumor size, tumor grade, and nodal status, according to Agendia’s CEO Bernhard Sixt. The test is currently used on stage I and II lymph node-negative breast tumors, to identify under- treated patients, or to help with difficult cases. After validation data comes in, the test might also be used in the future to determine patients who are over-treated, he added.
What differentiates Agendia’s test from other molecular diagnostics is the unbiased selection of genes, according to the company. “Compared to the current clinical guidelines, our test is significantly better,” Sixt said. “Funnily enough, the highest predictive value is a gene with unknown function.”
At the moment, Agendia provides the breast cancer test as a service through its own laboratory, and has no specific plans to sell it as a kit or to license it. This allows the company to adhere to its own quality-control standards, according to Sixt. “Quality is absolute key,” he explained.
A web site that will allow doctors worldwide to order the test will be operational later this month. At that time, oncologists can order tests online and receive results within 10 business days.
The test costs €1,650 ($2,000) — a “penetration pricing strategy,” according to Sixt. In the Netherlands, the government’s health-insurance system is reimbursing for the test on a trial basis.
Also, Agendia is currently 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 more than double its headcount to 30.
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 undisclosed cancers; these tests will also be based on NKI study results. Five years from now, Sixt said, the company hopes to have “three-digit-million euros per year” in revenues.
Agendia, based in Amsterdam, was founded last summer by researchers from the NKI. The company last week closed a Series A round in the “double-digit millions” of euros. Dutch investor Gilde Investment Management, Global Life Science Ventures, and French AXA Private Equity Venture Funds participated in the investment round.
Bas van der Baan, Agendia’s director of business development, said that the company is seeking to in-license additional expression profiles for cancer and other diseases.