[December 09, 2014]

New Clinical Data Supports the Use of FoundationOne® Heme to Enable Informed Treatment Decisions in a Wide Range of Hematologic Malignancies

Foundation Medicine, Inc. (NASDAQ:FMI) today announced new data demonstrating that FoundationOne® Heme, developed in collaboration with Memorial Sloan Kettering Cancer Center, provides critical genomic information that can impact prognosis, influence therapeutic strategy and even refine conventional pathologic diagnosis in patients with a wide range of hematologic malignancies. Collectively, these data highlight the potentially transformative impact of FoundationOne Heme across all aspects of cancer care. These findings were presented in two posters and an oral presentation at the American Society of Hematology Annual Meeting in San Francisco.

"We are pleased to see the presentation of these data, which support the utility of FoundationOne Heme as a valuable testing platform for patients with a broad range of hematologic cancers," said Vincent Miller, M.D., chief medical officer, Foundation Medicine. "Through FoundationOne Heme, our goal is to provide a physician with all of the relevant genomic information needed to make a more precise and informed treatment decision for their patients, which may include targeted therapies or clinical trials. We believe this approach represents the future of cancer care and are proud to be collaborating with Memorial Sloan Kettering to help transform routine clinical practice through comprehensive genomic profiling."

FoundationOne Heme is a comprehensive genomic profile that analyzes DNA of 405 genes and RNA of 265 genes that are most commonly altered in hematologic malignancies and sarcomas. The test was commercially launched in 2013, and is designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer.

"Genomic profiling has long been a critical part of the diagnostic workup across all hematologic malignancies, yet it is often necessary to perform multiple molecular, cytogenetic and hot-spot tests, an often overwhelming process that makes it especially difficult to interpret results and make therapeutic decisions based on the data," added Marcel van den Brink, M.D., Ph.D., Head, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center. "FoundationOne Heme is a single, comprehensive assay that detects all classes of actionable genomic alterations in cancer-driving genes, including fusions that are commonly tested for in hematologic malignancies utilizing other technologies, providing physicians with critical, easy-to-understand information that may ultimately lead to improved outcomes for patients."

Summary of Data Presentations:

• "Genomic Profiling Combining DNA and RNA Analysis of 112 Formalin-Fixed Paraffin-Embedded Diffuse Large B Cell Lymphoma Specimens Identifies a High Frequency of Clinically Relevant Genomic Alterations" (abstract number 704), an oral presentation, provides strong support for the utility of comprehensive genomic profiling to identify clinically relevant genomic alterations in a common type of lymphoma. In this study, 112 patients with diffuse large B cell lymphoma (DLBCL) were tested with FoundationOne Heme, and 96% were identified as having genomic lterations with diagnostic, prognostic or therapeutic relevance. These findings suggest that FoundationOne Heme's streamlined approach has the potential to replace multiple molecular and cytogenetic tests by combining them into a single, comprehensive platform that can be used across a wide spectrum of hematologic malignancies.
• "A Comprehensive Clinical Next Generation Sequencing-Based Assay Can Impact Hematopathologic Diagnosis in a Significant Subset of Patients with Hematologic Malignancies" (abstract number 2984), a poster, highlights the impact of FoundationOne Heme on pathologic assessment and diagnosis across a wide spectrum of hematologic malignancies, with the potential to augment or even replace conventional diagnostic tests commonly used in these diseases. In this study, 42 of 84 patients diagnosed with a hematologic malignancy (50%) were identified by FoundationOne Heme as having genomic alterations with diagnostic relevance. Importantly, in 14% of these cases (n=12), the identified alterations led to a change or refinement of the original diagnosis. Additionally, FoundationOne Heme identified genomic alterations with prognostic relevance in 64% of patients (n=54) and with potential therapeutic impact in 76% of patients (n=64). These data support the use of FoundationOne Heme as a first-line testing platform in a wide spectrum of hematologic malignancies, not only for identifying prognostic and therapeutic targets, but also for refinement of the underlying diagnosis.
• "Clinical Utility of Comprehensive Profiling of Genomic Alterations in Hematologic Malignancies," (abstract number 1072), a poster, demonstrates the ability of FoundationOne Heme to identify clinically relevant genomic alterations in a vast majority of patients across a broad range of hematologic malignancies. In this study, 705 of 746 patients (95%) who successfully underwent testing with FoundationOne Heme were identified as having at least one somatic-driver genomic mutation. Importantly, 68% of these patients (n=479) harbored at least one potentially actionable alteration linked to a targeted therapy or active clinical trial and 64% (n=451) had at least one alteration with prognostic relevance. Furthermore, genomic rearrangements were detected in tumors of 280 of 746 patients (n=38%), including novel rearrangements involving known oncogenes and tumor suppressor genes.

FoundationOne Heme is a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma), as well as many sarcomas and pediatric cancers, designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer. It is Foundation Medicine's second commercially available targeted sequencing assay and was developed in collaboration with Memorial Sloan Kettering Cancer Center. Using next-generation sequencing in routine cancer specimens, FoundationOne Heme interrogates all genes somatically altered in these cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. The test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions (a type of alteration that is a common driver of hematologic malignancies, sarcomas and pediatric cancers). FoundationOne Heme fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. FoundationOne Heme is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. Please visit www.FoundationOne.com for more information.

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, sarcomas and pediatric cancers, provide a fully informative 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 (News - Alert) (@FoundationATCG).

Foundation Medicine^® and FoundationOne^® are registered trademarks 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 clinical utility of FoundationOne Heme; the ability of FoundationOne Heme to affect the prognosis, treatment or diagnosis of cancer patients; and the ability of FoundationOne Heme to predict which patients would benefit from certain commercially available therapies or clinical trials. 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 FoundationOne Heme will not be able to identify genomic alterations in the same manner as prior clinical data, 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, 2013, which is on file with the Securities and Exchange Commission, as well as other risks detailed in subsequent filings with the Securities and Exchange Commission, may be realized. 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.

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