Cancer testing company Agendia BV has expanded into a larger Orange County laboratory.
Earlier this month, Agendia, which is headquartered in Amsterdam, moved its U.S. base to Irvine from Huntington Beach.
Agendia’s laboratory and headquarters now are in a 17,000-square-foot, two-story building at 22 Morgan near Bake Parkway and Jeronimo Road in the Irvine Spectrum. The space includes a first-floor laboratory and corporate offices on the second floor.
Agendia needed the extra room—it previously took up 2,500 square feet of space in a shared building—to accommodate growth, Chief Executive Bernhard Sixt said.
“The growth was so quick that the building we were in was not equipped to provide (needed) electricity and other infrastructure,” he said. The move is into “a significant standalone building, which represents what we really want to be—a strong, growing company.”
Test
Agendia makes MammaPrint, a test that assesses 70 genes and is designed to predict the reoccurrence of breast cancer in women who have been treated for the disease. MammaPrint received Food and Drug Administration approval in 2007.
The company’s other products include TargetPrint and BluePrint, which also are breast cancer tests.
Agendia—founded in 2004—has raised some $80 million in its history, including a $23 million round of venture funding in 2009. Investors include ING Groep NV and several Dutch venture capital firms.
Agendia’s new building has laboratory capacity that could be “easily quadrupled” if necessary, according to Sixt. The company has about 50 workers locally and 90 in all.
The move also came about because Agendia anticipates more competition.
“We are the only company with an FDA-approved breast cancer recurrence test. Up until now, there was kind of an uneven playing field because the competition didn’t comply (with) FDA rules,” Sixt said.
Last month, the FDA held public hearings on plans to regulate diagnostic tests that are manufactured and carried out in the same laboratory, which are called “laboratory-developed tests.”
Regulators say that if such tests aren’t properly validated, they could put patients at risk for things such as missed diagnosis, wrong diagnosis and failure to receive appropriate treatment.
Agendia and other entities, such as Bay Area biotechnology company Genentech Inc., testified in favor of regulating these tests. In a press release, Agendia argued that holding the tests to FDA scrutiny would “inspire greater confidence among investors to enter this emerging market.”
The company’s working on what Sixt called a second-generation, “better test” in response to the coming changes.
Other companies that provide gene-based breast cancer testing include Genomic Health Inc., a publicly traded company from Redwood City.
Sixt said he didn’t consider Clarient Inc., a publicly held cancer testing company based in Aliso Viejo, to be a competitor.
Sixt said the company’s working on “a serious foundation (to be) the No. 1 company in molecular diagnostics.”
Sixt declined to say how much revenue privately held Agendia has yearly.
It wants to grow as an independent company, he said.
“We will be a significant player, and a significant player is always looked on by external parties to potentially partner with or maybe even a party for acquisition,” Sixt said.
Other Tests
Agendia is expanding its core breast cancer focus and moving into other types of cancer tests. It is looking for FDA approval in 2011 for ColoPrint, a colon cancer test it’s developing, Sixt said.
On the breast cancer front, Agendia is participating in I-Spy 2, a clinical trial that’s going to evaluate women with high-risk, rapidly growing breast cancers.
It joins the FDA, the National Institutes of Health, Pfizer Inc. and Abbott Laboratories in the study.
