Originally published Aug. 4.
Agendia tomorrow will inaugurate a new clinical genomics laboratory in Irvine, Calif., that will nearly double its current lab space in the US as it looks to expand its commercial operations.
The company is moving its US operations from an 8,000-square-foot facility in Huntington Beach, Calif., to a 15,000-square foot space in Irvine. The firm also maintains a 13,000-square-foot facility in Amsterdam.
The company said in a statement that the new lab "will further increase capacity to support Agendia’s strong commercial expansion in the US market, as well as the use of multiple Agendia tests in clinical research."
Agendia CEO Bernhard Sixt said in a statement that the new lab's capacity will allow the company to meet "increasing demand" for its MammaPrint breast cancer recurrence test and will give physicians and patients "optimal test result turnaround and unmatched service and support."
A spokesperson for the privately held company declined to provide details on the growth in MammaPrint uptake, but noted that the firm is seeing "a large increase of requests, especially as Agendia now has acquired reimbursement from many large insurers."
Agendia has so far secured reimbursement from the Centers for Medicare and Medicaid Services and several major US insurers, resulting in coverage for MammaPrint for approximately 100 million lives.
Agendia currently employs 90 people worldwide and plans to hire more employees for the larger facility.
"Looking at the increase in sample volume, we expect a substantial amount of hiring within operations and sales," the spokesperson said via e-mail. "As result, supporting departments, like Regulatory and QA, will expand their departments."
In addition to the increase in testing volume, the company is also expanding its product pipeline and looking to participate in more clinical trials and collaborations with pharmaceutical partners, the spokesperson said.
Regarding long-term growth, the company expects that the new facility will be sufficient for several years. In particular, technical and quality improvements in Agendia's services, such as increased density of microarrays and improved automation, will enable the company to increase its capacity without expanding its footprint.
However, the spokesperson noted, "regulatory, reimbursement, or logistical requirements might trigger Agendia to open new facilities. In particular, Asia could be a market where this may happen in the future."
In 2007, MammaPrint was the first in vitro diagnostic multivariate index assay to receive 510(k) clearance from the US Food and Drug Administration. Since then, the 70-gene microarray based test has gained clearance three additional times — most recently as a prognostic test for women over 61 years of age with either estrogen receptor-positive or ER-negative, lymph node-negative breast cancer (PGx Reporter 12/23/2009).
This article has been updated from a previous version to clarify the indication for the company's most recent FDA clearance.