Foundation Medicine, Inc.
January 13, 2016
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Foundation Medicine, Horizon Healthcare Services, Inc. and COTA Collaborate to Demonstrate the Benefits of a Precision Medicine Treatment Approach for Patients with Metastatic Non-Small Cell Lung Cancer

Study Aims to Demonstrate the Clinical Utility of, and Cost Savings Achieved by, Integrating Comprehensive Genomic Profiling with FoundationOne® into Clinical Pathways

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced a three-way collaboration with Horizon Healthcare Services, Inc., New Jersey's oldest and largest health insurer, and Clinical Outcomes Tracking and Analysis (COTA) to advance precision medicine, improve clinical outcomes and deliver enhanced value to the healthcare system in the treatment of patients with metastatic, non-small cell lung cancer (NSCLC). The organizations initiated a prospective clinical study measuring changes in survival benefit and total cost savings achieved among patients with previously untreated metastatic NSCLC who undergo comprehensive genomic profiling with FoundationOne®. Based on the outcomes, the study enables Horizon to provide its members with coverage for FoundationOne as a critical component of clinical care pathways in the evaluation of patients with metastatic lung cancer.

As thought leaders and innovators in cancer care, the organizations designed the study to support guidelines from the National Comprehensive Cancer Network (NCCN) that specifically recommend broad molecular profiling for patients with NSCLC. These guidelines enable the identification of cancer-driving genomic alterations for which effective targeted therapies may already be approved and available commercially or to enable physicians to appropriately counsel patients regarding the availability of clinical trials. This recommendation by NCCN and the genesis of this trial supports the widespread understanding that cancer is a disease of the genome and that tumors may harbor specific genomic alterations likely to respond to "matched" therapies regardless of its anatomic site of origin.

FoundationOne is a comprehensive genomic profile (CGP) that enables physicians to make treatment decisions for patients with cancer by identifying the molecular growth drivers of their cancers and by helping oncologists match the identified drivers with relevant targeted therapeutic options. Requiring only a small amount of tumor tissue, FoundationOne interrogates the entire coding sequence of 315 cancer-related genes plus select introns from 28 genes that are known to be altered in solid tumors.

"We believe this study design, which embraces the importance of data sharing in molecular information, represents an innovative model of collaboration that will catalyze the consistent integration of comprehensive genomic profiling in clinical care for the treatment of metastatic lung cancer," stated Vincent Miller, M.D., chief medical officer for Foundation Medicine. "We fully expect the study to demonstrate the clinical and health economic benefits of a comprehensive approach versus the use of more limited testing panels and importantly, that these results will support broad reimbursement in this patient population with advanced disease," Miller added.

"Gene-by-gene testing, as is common practice today in metastatic NSCLC, presents clinical and logistical challenges, including missing alterations, insufficient tissue for testing, and a significant loss of precious time in identifying a clinical course of care," said Andrew Pecora, M.D., F.A.C.P., C.P.E., member of Regional Cancer Care Associates and chief innovation officer, Professor and vice president of Cancer Services, John Theurer Cancer Center at HackensackUMC. "The availability of a single CGP assay to accurately identify all known variants from a single sample and to accommodate the expanding list of genomic markers in metastatic NSCLC without necessitating new biopsies is a medical necessity."

"Horizon believes in investigating whether a comprehensive genomic approach could yield the most robust information to guide clinical treatment options - either to approved or investigational therapies - through clinical trials," said Glenn D. Pomerantz, M.D., JD, vice president and chief medical officer with Horizon. "Ultimately, we hope that working with Foundation Medicine on this approach will optimize outcomes for metastatic lung cancer patients."

Patients will be enrolled at Regional Cancer Care Associates (RCCA) and Hackensack Medical University in New Jersey. Patient outcomes will be tracked by Clinical Outcomes Tracking and Analysis (COTA). Horizon Blue Cross of New Jersey will pay for enrolled patients to receive FoundationOne assays as part of the study.

About COTA, Inc.

Developed by world-leading oncologists, COTA, Inc. has developed the unique CNA (COTA Nodal Address) System to precisely classify cancer patients into meaningful clinical and prognostic cohorts. Using this sorting technique, COTA is able to account for the biologic variances of cancer, thus permitting more in-depth analyses of treatment variances. This enables doctors and health plans to improve patient care and move from fee-for-service to value-based reimbursement models. COTA offers providers, patients and payers with the actionable, real-time insights needed to improve clinical outcomes, while reducing the costs. Based in New York City, the Company's mission is to enable optimal care for every cancer patient. To learn more about COTA, call (866) 648-3833 or visit www.oncota.com.

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).

About Horizon Healthcare Services, Inc.

Horizon Healthcare Services, Inc., New Jersey's oldest and largest health insurer, is a tax-paying, not-for-profit health services corporation, providing a wide array of medical, dental, and prescription insurance products and services. Horizon Healthcare Services, Inc. serves 3.8 million members with headquarters in Newark and offices in Wall, Mt. Laurel, and West Trenton. Learn more at www.HorizonBlue.com.

About Regional Cancer Care Associates

Regional Cancer Care Associates (RCCA), the largest oncology physician network in New Jersey, is transforming oncology care by ensuring patients and their caregivers are an active part of the treatment team in all aspects of the management of their disease in a way that is life-enriching and respectful. Regional Cancer Care Associates extends across New Jersey with more than 90 cancer care specialists, growing to include more than 100, and is supported by 600 employees at 27 care delivery sites, providing care to more than 20,000 new patients annually and over 230,000 existing patients. For more information, visit www.regionalcancercare.org.

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. 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 clinical study is delayed, discontinued or is not otherwise successfully completed; that the outcomes from the clinical trial are not positive and do not support the hypotheses developed by the study sponsors; that the outcomes to do not provide sufficient support for Horizon to provide its members with coverage for FoundationOne; 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.

Media Contact:
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Investor Contact:
Foundation Medicine
Kim Brown, 617-418-2215
ir@foundationmedicine.com

Source: Foundation Medicine

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