By Diagnostics World Staff
November 3, 2016 | Flatiron Health and Foundation Medicine 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 database is available to Flatiron and Foundation’s research, academic, and life sciences partners. These partners can now access a real-world, ever-growing dataset in which they can not only learn what genomic alterations patients have, but also what treatment options were used, which treatments worked best, and how patients responded over a long period of time.
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.
“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,” said Amy Abernethy, MD, PhD, chief medical and chief scientific officer, Flatiron Health.
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, president and chief operating officer for 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 database is comprised of curated data that is generated as the result of real-world, routine care rather than a concerted prospective research effort. As a result, new patients are always entering the database: anytime a patient undergoes tumor sequencing by Foundation Medicine, at a practice for which Flatiron curates EHR data, the patient is added to the database. Both Flatiron and Foundation Medicine are rapidly growing companies, and the database's trajectory will reflect this growth naturally,” a representative of Flatiron told Diagnostics World via email.
The two companies are exploring partnerships within the broader research and academic community to accelerate utilization of this clinico-genomic database for novel drug development and clinical trial applications.
“Flatiron and Foundation share similar visions of hyper focusing our technology efforts to fight cancer,” said the Flatiron representative. “Foundation takes the genetic sequencing approach, Flatiron is able to offer real-world patient data to our partners. When the technology is combined it offers up a new way to diagnose and treat patients in a personalized way. We see these as the first step in larger personalized medicine collaborations.”