Foundation Medicine Announces First-Ever Public Release of Broad Pediatric Data From FoundationCORE to Accelerate the Development of Precision Medicine Strategies for Pediatric Cancers

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Foundation Medicine Announces First-Ever Public Release of Broad Pediatric Data From FoundationCORE to Accelerate the Development of Precision Medicine Strategies for Pediatric Cancers

-Data Release Announced Today at White House Precision Medicine Initiative Summit-

February 25, 2016 06:05 AM Eastern Standard Time

CAMBRIDGE, Mass., & WASHINGTON--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the company will release to the public molecular profiles of pediatric cancers currently maintained as part of FoundationCore™, the company's information knowledgebase. FoundationCORE is one of the largest and most robust collections of common and rare clinical tumor profiles globally. The release of this data is part of the company's ongoing effort to stimulate and accelerate research and development of much needed precision oncology therapies to treat all cancers, including pediatric cancers. The announcement of the data release, which is the first-of-its-kind from FoundationCORE, was announced today at the Precision Medicine Initiative Summit held at the White House.

"One of the biggest impediments to progress in the field of childhood cancer is the paucity of genomic data available from patients at the time of disease relapse. These data are critical to defining comprehensive strategies to precisely treat relapsed disease, and more importantly, to prevent disease recurrence in the first place," stated John M. Maris, M.D., Giulio D'Angio Endowed Professor of Pediatric Oncology at Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania. "The data being made available from Foundation Medicine will serve as a tremendous resource for the cancer research community and should catalyze the process of bringing effective new therapies to children with cancer."

FoundationCORE is a molecular information knowledgebase that contains genomic information and insights from more than 68,000 adult and pediatric patients whose tumors were profiled by Foundation Medicine. FoundationCORE is continuously evolving over time, informed by every new tumor sequenced with the company's clinical comprehensive genomic profiling assays, FoundationOne® and FoundationOne® Heme. Foundation Medicine is developing a web-based HIPPA-compliant portal for public access to the de-identified, molecular-level pediatric tumor information contained in FoundationCORE. The portal is expected to be accessible for public access by March 31st.

"The proposed release of data by Foundation Medicine is a major advance towards achieving our nation's precision medicine initiatives, particularly in an area of significant unmet need for children," said Nancy Goodman, executive director, Kids v Cancer. "This type of out-of-the-box initiative gives great hope to the families and patients who need it most. We're looking forward to the renaissance in targeted and immunotherapies for children that may come as a result of this data."

Pediatric cancers are a rare and diverse collection of diseases. While childhood and adolescent cancer is rare, it remains the leading cause of death by disease among children. The American Cancer Society predicted that about 10,380 children in the United States would be diagnosed with cancer in 2015 and childhood cancer rates have been rising slightly for the past few decades.1 The data set being released from FoundationCORE offers robust opportunities for researchers, and can be used to generate hypotheses, validate rare findings and investigate the genomic landscape of rare tumors for which only small studies exist. Data from thousands of tumors will be publicly available without cost to the research community for exploration and incorporation into future experiments that will ultimately improve the treatment and prognosis for children with cancer.

"There are few things in life as devastating as when a child is diagnosed with cancer. It's critically important to the achievement of our corporate mission that the robust genomics information we have amassed is freely and easily accessible to researchers and utilized as an important tool to address the significant unmet medical need in pediatric cancers," said Michael Pellini, M.D., chief executive officer, Foundation Medicine. "We are extremely proud to be in a position that enables us to foster global collaborations among researchers by providing anywhere, anytime access to rich molecular information in an easy to use format. In doing so, we hope to accelerate the pace of innovation in pediatric cancer with the intent of bringing new, potentially lifesaving therapeutics to children."

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's clinical assays, FoundationOne® for solid tumors and FoundationOne® Heme for hematologic malignancies and sarcomas, provide a comprehensive genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies 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® and FoundationOne® are registered trademarks, and FoundationCORE™ is a trademark, 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. 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 risks that the release of pediatric data by Foundation Medicine may not occur as anticipated, may be delayed or may not occur at all; that the electronic portal for such pediatric data may not be accessible; that the pediatric data may not be as robust as anticipated or may not generate additional research and development opportunities; and the risks described under the caption "Risk Factors" in Foundation Medicine's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, 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.

1 American Cancer Society, www.cancer.org