FMI Foundation Medicine Inc.

Foundation Medicine and European Organisation for Research and Treatment of Cancer (EORTC) Announce Collaboration to Advance Precision Medicine Using Comprehensive Genomic Profiling to Facilitate Clinical Trial Enrollment

Foundation Medicine, Inc. (NASDAQ:FMI) and the European Organisation for Research and Treatment of Cancer (EORTC) announced today a collaboration in which Foundation Medicine’s comprehensive genomic profiling (CGP) tests will be used to inform patient eligibility for oncology clinical trials through the EORTC’s Screening Patients for Efficient Clinical Trial Access (SPECTA) program. SPECTA is a pan-European network built by the EORTC with key institutions collaborating to provide efficient access for patients to molecularly driven clinical trials.

“Oncology clinical trials are essential to advancing research and drug development while enabling patient access to potential clinical treatment options. Yet, currently only a small fraction of cancer patients enroll in clinical trials,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “The EORTC is a renowned leader in integrated translational research, and their SPECTA program is an exciting opportunity for oncologists to utilize our robust genomic profiling tests to more efficiently match patients with appropriate clinical trials. Together, Foundation Medicine and the EORTC can work toward improved access to innovative clinical trials, helping to accelerate precision oncology for more patients.”

The collaboration brings together the EORTC, an independent, non-profit clinical research organization in cancer, and Foundation Medicine, a leader in molecular information that offers a suite of CGP assays that identifies the molecular alterations in an individual’s cancer to inform precision medicine treatment approaches.

“SPECTA serves as a shared and integrated translational and clinical research infrastructure for knowledge development and ultimately allows matching patients to clinical trials based on both their clinical characteristics and the molecular profiles of their tumors,” said Denis Lacombe, M.D., EORTC Director General. “Our collaboration with Foundation Medicine will provide access to innovative, biomarker-driven clinical trials that will ultimately usher in a new era of targeted therapy in oncology.”

Under the agreement, Foundation Medicine will provide genomic testing services for the SPECTA program through three of its genomic profiling assays: FoundationOne®, its flagship assay for solid tumor cancers that includes analysis of genomic biomarkers such as microsatellite instability (MSI) and tumor mutational burden (TMB), FoundationOne®Heme, an assay for hematologic malignancies and sarcomas that also includes MSI analysis, and FoundationACT®, a liquid biopsy assay for solid tumors. Genomic profiling results will help inform patient eligibility and facilitate enrollment in clinical trials. Samples will be processed at any one of Foundation Medicine’s laboratories located in the United States and Europe.

About EORTC

The European Organisation for Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 4000 collaborators from all disciplines involved in cancer treatment and research in more than 800 hospitals and institutions in over 35 countries.

Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programmes and medical practices. EORTC Headquarters, a unique pan-European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.

About Foundation Medicine

Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine®, FoundationOne®, FoundationOne®Heme and FoundationACT® are registered trademarks of Foundation Medicine, Inc.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the value and performance capabilities of Foundation Medicine’s comprehensive genomic profiling (CGP) assays; the ability of Foundation Medicine’s CGP assays to identify patients eligible to participate in specific clinical trials, help improve efficiencies, and streamline clinical trial enrollment; and the ability of a clinical trial to accelerate precision oncology, expand access to therapies, or improve cancer care. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that Foundation Medicine’s CGP assays and services will not be able to identify genomic alterations in the same manner as prior clinical data or prior experience; clinical trial enrollment does not become more efficient or increase in the expected manner; and the risks described under the caption “Risk Factors” in Foundation Medicine’s Annual Report on Form 10-K for the year ended December 31, 2016, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

EN
30/01/2018

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