PRESS RELEASE

  • Simultaneous creation of Global Lab Center of Excellence

IRVINE, CALIF., U.S., and AMSTERDAM, NETHERLANDS – 17 April 2019 – Agendia, Inc., a world leader in precision oncology, announced today that it has created a new Center of Innovation and R&D Excellence in the Netherlands to leverage the considerable technical expertise and experience of its scientists, researchers and collaborators in the European market, and to accelerate advancing next generation sequencing technology in the diagnostics space.

A strong focus of the Center of Innovation and R&D Excellence will be product support of Agendia’s current next generation sequencing (NGS) offering for the rapidly growing base of customers in Europe and Asia employing the decentralized proprietary testing. The current offering of the combined MammaPrint® and BluePrint® testing addresses multiple treatment decisions for patients with breast cancer. A second and equally important focus for the Center is the discovery and development of additional global service and product offerings using NGS technology. Patient samples for clinical assessment designated for microarray analysis, one of the testing platforms offered by Agendia, will be consolidated in the Irvine, CA laboratory at the Agendia Lab Center of Excellence.

In Europe, Agendia will focus on serving customers through in-country testing using next generation sequencing. Agendia has contracted, trained and certified several European sites to perform de-centralized MammaPrint and BluePrint NGS testing. Additional laboratories in the EMEA region have communicated their strong interest in collaborating with Agendia and soon will be able to provide this service to physicians and patients in their respective countries. European customers ordering tests processed with microarray technology will continue to experience the same high level of service as delivered previously as Agendia’s Amsterdam office remains the center for physician and patient contact.

Mark Straley, Agendia CEO, said, “We are very pleased to strengthen Agendia’s scientific legacy in the Netherlands by advancing our focus on next generation sequencing. Fifteen years ago, Amsterdam Genomics Diagnostics (Agendia) was founded by exceptional, world-renowned researchers from the Netherlands Cancer Institute. We attribute our current scientific strength to our beginnings and we are confident in the Center of Innovation and R&D Excellence to continue this tradition for our future.”

About MammaPrint®

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN®). The test is also recommended by many other national and international clinical practice guidelines.

About BluePrint®

BluePrint is an 80-gene complementary gene expression test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About Agendia

Agendia is a privately held, leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology.

The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.

In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information on Agendia or the MammaPrint and BluePrint tests, visit agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.