CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that it has signed a national agreement for FoundationOne®, a comprehensive genomic profiling assay for solid tumors, with UnitedHealthcare, one of the nation’s largest private payers. The Agreement, which became effective December 15, 2015, covers FoundationOne for patients with metastatic stage IV non-small cell lung cancer (NSCLC). In the United States, approximately 50 percent of patients with NSCLC have metastatic disease at the time of diagnosis.1
FoundationOne is a comprehensive genomic profile 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.
“UnitedHealthcare’s coverage decision is a critical first step towards ensuring that comprehensive genomic profiling becomes standard-of-care treatment for patients with metastatic disease,” said Bonnie J. Addario, lung cancer survivor, and founder of the Bonnie J. Addario Lung Cancer Foundation and the Addario Lung Cancer Medical Institute. “Lack of reimbursement for comprehensive genomic profiling tests, like FoundationOne, continues to be one of the major barriers impeding patient access to potentially life-extending therapies for which the patient is a molecular match.”
“This national coverage agreement with UnitedHealthcare is an important step towards broader reimbursement for Foundation Medicine, and importantly, it’s a significant advance for patients with metastatic NSCLC,” said Michael Pellini, M.D., chief executive officer for Foundation Medicine. “Studies demonstrate that improved clinical outcomes are achieved by matching patients to targeted therapies based on the unique genomic alterations contributing to the disease. We look forward to building upon our relationship with UnitedHealthcare and other national insurers as we continue to demonstrate clinical and economic evidence supporting coverage and payment for FoundationOne in additional cancer types.”
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).
1Kantar Health CancerMPact database.
Foundation Medicine® and FoundationOne® 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 potential for comprehensive genomic profiling to become standard-of-care treatment for patients with metastatic disease, the expansion Foundation Medicine’s relationships with national insurers and the development of clinical evidence supporting coverage for FoundationOne in additional cancer types. 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 comprehensive genomic profiling does not become a part of standard-of-care treatment for patients with metastatic disease, Foundation Medicine’s relationships with national insurers does not increase or expand, clinical evidence supporting coverage for FoundationOne in additional cancer types does not develop, 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.