NEW YORK, NY & CAMBRIDGE, MASS., November 3, 2016 – Flatiron Health and Foundation Medicine, Inc. (NASDAQ:FMI) today announced the launch of a clinico-genomic database designed to help researchers and biopharmaceutical partners accelerate the development of targeted therapeutics and immunotherapies to treat cancer. The clinico-genomic database, containing information on nearly 20,000 patients, is one of the largest and most comprehensive information efforts of its kind in oncology. The HIPAA-compliant database integrates rich genomic profiling data from patients whose tumors were sequenced with Foundation Medicine’s comprehensive genomic profiling (CGP) assays with annotated longitudinal clinical and outcomes data developed by Flatiron from electronic health records (EHR). By making clinico-genomic data available as part of the clinical research process, researchers will have access to real-world information in designing the next generation of oncology therapeutics and clinical trials, ultimately paving the way for new and more precise therapies for cancer patients.
“We are incredibly excited to introduce in partnership with Foundation Medicine this clinico-genomic database,” said Amy Abernethy, M.D., Ph.D., chief medical and chief scientific officer, Flatiron Health. “This collaboration enables us to help researchers and life science companies use real-world evidence inclusive of detailed genomic information, patient and disease clinical characteristics, treatments received, and patient-level outcomes like disease progression, tumor response and mortality to identify patient populations with unmet needs and expedite plans for drug development and clinical trials.”
The clinico-genomic database includes de-identified linked clinical and genomic data from patients across a variety of tumor types allowing for a continuously updated, longitudinal view of a patient’s clinical, diagnostic and therapeutic journey. The database combines anonymized, HIPAA-compliant, research-grade patient data, including diagnosis, treatment and clinical outcomes captured through Flatiron’s EHR data collection platform. This data is matched with deep, highly validated molecular information, including genomic findings, variant interpretations and bio-informatic data, generated by FoundationOne®, FoundationOne® Heme and FoundationACT™.
“Foundation Medicine and Flatiron together are uniquely positioned to accomplish what many others in oncology are trying to achieve, namely, delivering a highly validated lens into rich longitudinal clinico-genomic data and analysis to advance therapeutic development,” said Steven Kafka, Ph.D., president and chief operating officer, Foundation Medicine. “We look forward to working with our biopharma collaborators to leverage this unique data set to help advance and accelerate the development of precision therapeutics.”
Expected to grow in the coming months, the clinico-genomic database is the first of several products that Foundation Medicine and Flatiron plan to co-develop using a comprehensive, HIPAA-compliant information platform. The two companies are exploring partnerships within the broader research and academic communities to accelerate utilization of this clinico-genomic database for novel drug development and clinical trial applications.
ABOUT FLATIRON HEALTH
Flatiron Health is a healthcare technology company harnessing the power of real-world data to accelerate research and improve cancer care. The company works with healthcare providers, life sciences organizations and academic centers to collect, aggregate and analyze data for over 1.5 million active cancer patients. Today, over 250 cancer clinics and 10 of the top 12 life science companies are using Flatiron’s platforms. Flatiron is backed by Google Ventures, First Round Capital, Roche and others. For more information, please visit http://flatiron.com or follow Flatiron on Twitter.
Flatiron Health® is a registered trademark of Flatiron Health, Inc.
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®, FoundationOne® and FoundationOne® Heme are registered trademarks and FoundationACT™ 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 implementation of the collaboration between Foundation Medicine and Flatiron, the ability Foundation Medicine and Flatiron to grow the database, the utility of the clinico-genomic database, and the ability of the clinico-genomic database to effectively support the research requirements of researchers and biopharmaceutical companies involved in drug development and 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 risks that the collaboration is not implemented or is not implemented as quickly or as fully as anticipated; Flatiron is not able to gain access to sufficient amounts of clinical information and Foundation Medicine is not able to generate sufficient amounts of genomic data to create a robust and successful product; the clinico-genomic database does not perform as expected or is not widely adopted or used by researchers; the clinico-genomic database is not financially sustainable; 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, 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 and Flatiron undertake no duty to update this information unless required by law.