Agendia, a world leader in molecular cancer diagnostics, today announced the inauguration of a new state-of-the-art clinical genomics laboratory in Irvine, CA. Previously, Agendia's offices and laboratory were located in Huntington Beach, CA. The new laboratory will further increase capacity to support Agendia's strong commercial expansion in the U.S. market, as well as the use of multiple Agendia tests in clinical research. MammaPrint, the company's lead product and the only FDA-cleared breast cancer recurrence test, is reimbursed by an increasing number of payers, covering some 100 million lives today.
In addition, MammaPrint plays a central role in the recently initiated I-SPY 2 trial, which is a revolutionary breast cancer trial and an initiative of the Biomarkers Consortium, a unique public-private partnership that includes the Food and Drug Administration, the National Institutes of Health, and major pharmaceutical companies, led by the Foundation for the National Institutes of Health. The I-SPY 2 trial, which will enroll patients at 20 leading U.S. cancer research centers, will also rely on Agendia's TargetPrint to provide objective, quantitative information about the expression of the specific tumor-related proteins, ER, PR and Her-2neu, while Agendia's DiscoverPrint will measure the expression of the whole genome for all enrolled patients. These tests allow the study researchers to more quickly identify which investigational drugs offer the most benefit for women with certain tumor characteristics.
The new Irvine facility consists of corporate offices and a 15,000 square foot, state-of-the-art genomics laboratory. A large group of California politicians and other VIPs attended the inauguration, including the Mayor of Irvine, Sukhee Kang, and representatives of patient organizations and clinicians.
"Our new genomics lab's capacity will allow us to meet the increasing demand for MammaPrint across the United States and give physicians and patients optimal test result turnaround and unmatched service and support," said Dr. Bernhard Sixt, President and Chief Executive Officer. "This expansion places us in an excellent position to continue making advancements in molecular cancer diagnostics and equip oncologists with powerful tools to use in the fight against breast cancer."
As the U.S. Food and Drug Administration prepares to regulate Laboratory Developed Tests (LDTs) for the first time, Agendia finds itself in an exceptionally strong position, having already secured 4 separate FDA IVDMIA clearances for MammaPrint, establishing the company as the only developer of a breast cancer recurrence test that is already validated by the FDA. The launch of the new Irvine facility speaks to the company's growth and success in the US marketplace.
Ongoing research and development commitments continue to augment Agendia's ability to accurately predict breast cancer recurrence and sub-typing, and help physicians tailor individual treatment plans to their patients. Agendia's goal is to provide women with answers to crucial treatment questions, such as how their breast cancer will respond to targeted therapies or various chemotherapy regimens.
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