CAMBRIDGE, Mass. & HACKENSACK, N.J.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ: FMI) and COTA, Inc. today announced an agreement to capture and analyze comprehensive genomic, clinical outcome, and cost data from patients who have undergone testing with FoundationOne®. The resulting dataset is designed to provide health care providers and payers with the supporting clinical outcomes and costs evidence that inform value-based reimbursement decisions and cancer treatment.
“Eliminating inefficiencies and improving patient care requires actionable insights supported by complete, integrated data,” said Eric Schultz, CEO of COTA. “This unprecedented collaboration with Foundation Medicine incorporates the most comprehensive genomic profiling data with COTA’s unique real-world, longitudinal clinical outcomes and cost of care data to provide insights that enable both physicians and payers to move toward value-based treatment and reimbursement practices.”
The collaboration will first capture clinical outcomes for patients with Stage IV non-small cell lung cancer (NSCLC), the leading cancer killer of men and women in this country, who have undergone testing with FoundationOne. The resulting longitudinal data will aim to further demonstrate the clinical utility of comprehensive genomic profiling for patients with Stage IV NSCLC and to inform potential value-based reimbursement decisions from payers. The combination of genomic data, clinical information, outcomes data and economic data will provide critical insights for both payers and physicians to fully endorse the clinical and economic benefits associated with the application of comprehensive genomic profiling in this disease setting.
“The capture of clinical outcomes resulting from treatment selection informed by our comprehensive genomic profiles is essential to demonstrating the clinical and economic value of FoundationOne and to expanding utilization and access for these tests,” said Michael Pellini, CEO of Foundation Medicine. “We are pleased to work in partnership with COTA on this initiative to provide additional clarity of the impact on patient outcomes and cost of care that result from our comprehensive genomic profiling tests. We look forward to enhancing our robust collection of evidence with this integrated data package to support broader payer coverage and value-based reimbursement for our tests.”
Initially, Foundation Medicine and COTA will identify patients who are newly diagnosed with Stage IV NSCLC and are enrolled in a health plan that has agreed to participate in this phase of the collaboration. Subsequent phases of the collaboration, which are currently under discussion, may include integration across the remainder of the clinical scenarios included in the appropriate use of FoundationOne and FoundationOne Heme.
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 www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).
FoundationOne is a comprehensive genomic profile for solid tumors used by oncologists to identify the molecular alterations in a patient's tumor and match those alterations with relevant targeted therapies and clinical trials. Using next-generation sequencing in routine cancer specimens, FoundationOne interrogates all genes somatically altered in human cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations including base substitutions, insertions, deletions, copy number alterations and select rearrangements. FoundationOne 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 is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. Please visit www.FoundationOne.com for more information.
About FoundationOne® Heme
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.
Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.
About Cancer Outcomes Tracking and Analysis (COTA, Inc.)
Developed by oncologists for oncologists and their patients, COTA, Inc. is a cloud-based platform that 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 the real-time data they need to improve clinical outcomes, while reducing the costs. Based in New Jersey, the Company’s mission is to enable optimal care for every cancer patient by generating actionable, real-time data. To learn more about COTA, call (866) 648-3833 or visit www.cotatrack.com.
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 creation of a dataset combining genomic and clinical outcomes information and the potential utility of the dataset for patients, physicians and payers, including for treatment and reimbursement decisions. 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 dataset is not completed due to the inability to collect or combine sufficient amounts of data; that the results from the dataset are not statistically significant; that the results do not demonstrate the potential clinical utility of comprehensive genomic profiling for patients with Stage IV NSCLC or other cancers; that the dataset does not assist payers to make value-based reimbursement decisions; 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 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.