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Real-world data vs. MS
MOUNTAIN VIEW, Calif. & SACRAMENTO, Calif.—Multiple sclerosis (MS), a potentially disabling immunologic disease affecting more than 2.3 million people worldwide, has no known specific cause and no cure. DNAnexus Inc., which specializes in biomedical informatics and data management, and the not-for-profit Sutter Health network have launched what they say is the first large-scale clinico-genomic MS research study conducted by a leading healthcare system.
In the program, scientists at the Sutter Health Center for Precision Medicine—a large healthcare system with a diverse patient base—will input de-identified clinico-genomic datasets from more than 3,000 patients to the DNAnexus Apollo Platform. This reportedly will enable rapid analysis, visualization and collaboration within a secure environment that complies with rigorous patient confidentiality requirements. The UPMC Genome Center, a leading non-profit health system based in Pittsburgh, will produce clinical-grade genomic data from samples contributed by the program’s participants.
Beginning in May 2019 and continuing for nine to 12 months, researchers at Sutter will enroll more than 500 MS patients in the first phase of the new study, designed to collect electronic health record (EHR) data, patient-reported outcomes, imaging data and blood samples, in addition to whole-exome sequencing (WES) performed by UPMC. DNAnexus bioinformatics experts will process WES data through analysis pipelines and link the resulting genetic data with extensive clinical data on the DNAnexus Apollo Platform.
Sutter Health clinicians, researchers and approved collaborators will use the platform to assess patients’ clinical and genomic features that correlate with MS subtypes, disability progression, staging, symptoms, MRI changes and differential response to disease-modifying therapies. The study focuses on clinical aspects of MS, the history of treatment, imaging, working with patients directly and having them fill out questionnaires. Sutter identified the five largest clinics within the system to achieve diversity and breadth of patients and disease types to avoid a homogeneous population.
“Sutter has a complex data environment with a diverse data set not obtainable easily or siloed in different buckets,” explained Richard Daly, CEO of DNAnexus. “With its diverse patient population and powerful EHR data on long-term MS patients, the team at Sutter Health is poised to lead this next era of precision medicine for MS.”
He added, “Our program of data structure and harmonization, in which we merge data electronically and provide human interaction for curation, results in real-world data that is reliable and usable by clinicians and anyone else wanting it for investigator-initiated trials, program management, pharmaceutical research and FDA analysis. Real-world evidence can reform clinical trial methodologies for clinicians, pharmaceutical researchers and FDA monitors.”
According to Dr. Gregory Tranah, director of the Center for Precision Medicine at Sutter Health, “Datasets generated in a real-world setting will propel Sutter Health to discover biomarkers and understand disease progression and treatment response in MS. Collaborating with DNAnexus allows access to cutting-edge bioinformatics tools to better understand our clinically meaningful ‘big data’ by bringing together complementary skills and research capabilities.”
He continued, “This is an important step to advance precision medicine efforts across Sutter and, ultimately, to improve treatments for people with MS in our community and the millions of people affected with the disease worldwide. We will be able to do discovery and implementation to achieve results.”
In this collaboration, DNAnexus is launching its new Clinico-Genomic Data Solution, a program that addresses the demand for high-quality, longitudinal, disease-specific datasets by establishing a network of healthcare partners dedicated to improving screening, diagnosis and treatment pathways for complex diseases, according to Daly. The network facilitates an ongoing data stream hosted on the DNAnexus Apollo Platform to support precision health initiatives and drug discovery programs at leading cancer centers, academic institutions, healthcare providers and pharmaceutical companies.