FMI Foundation Medicine Inc.

Foundation Medicine Launches Gene Expression Profiling Program to Identify Known and Novel Biomarkers in Advanced Cancer

Foundation Medicine, Inc. (NASDAQ:FMI) today announced a comprehensive gene expression profiling (GEP) program to support precision oncology clinical research and development. This initiative, which provides a natural complement to Foundation Medicine’s comprehensive genomic profiling (CGP) suite of molecular information tests, further enhances support for the Company’s biopharma partners in the efficient identification of known and novel genomic and expression-based biomarkers of response for investigational and approved personalized cancer therapies, including new and existing cancer immunotherapies.

“In order to maximize the potential of personalized cancer therapy, we need a comprehensive biomarker strategy that includes not only tumor mutational changes and signatures but robust readouts of gene expression, requiring deep expertise in next generation DNA and RNA sequencing,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “The initiation of a GEP program at Foundation Medicine is a natural extension of our work in redefining genomic biomarkers for precision oncology treatments, and we are excited to combine this expertise to help our biopharma partners optimize their clinical research development programs. Bringing together Foundation Medicine’s unique combination of comprehensive genomic sequencing and gene expression could help determine which therapeutic approach is right for each patient and each tumor type as we develop new classes of personalized cancer treatments with our biopharma partners.”

CGP of individual tumors is critical to advancing precision oncology. Through its suite of CGP assays, Foundation Medicine has pioneered the measurement of quantitative genomic biomarkers, including microsatellite instability (MSI) and tumor mutational burden (TMB), which are informing immunotherapy research, clinical development and treatment decisions.

Building on Foundation Medicine’s existing DNA and RNA sequencing platforms, GEP has the potential to provide insights into gene expression signatures that may serve as predictive biomarkers of immunotherapy response. For example, measuring expression of genes tied to tumor-infiltrating lymphocytes, T-cell proliferation, and T-cell receptor diversity have all been associated with response to different types of oncology treatments. Under this program, Foundation Medicine will initially provide research-use only GEP for its biopharma partners. Such collaborations help integrate novel genomic biomarkers into clinical practice and optimize clinical trial design and drug development. Together this may pave new paths for the biopharmaceutical industry to expand the potential of precision oncology.

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® is a trademark of Foundation Medicine, Inc.

Cautionary Note Regarding Forward-Looking Statements for Foundation Medicine

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 ability of gene expression profiling to identify novel genomic and expression-based biomarkers of response; the ability of CGP to advance prevision oncology or improve patient outcomes; and the benefits of Foundation Medicine’s gene expression profiling program to biopharma partners, including optimizing clinical research development programs and drug development. 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 the gene expression profiling program does not proceed or does not meet its objectives; gene expression profiling is not an effective method of identifying genomic and expression-based biomarkers; the utility of gene expression profiling for biopharma partners does not materialize; 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, 2017, 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
02/05/2018

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