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Updates Released to GW, FDA BioCompute Object Specification Project to Standardize Genomic Data Analysis

GW-led consortium and the FDA to release “BioCompute Specifications 1.2” on Oct. 11

WASHINGTON (Oct. 11, 2018) — The George Washington University (GW) and the U.S. Food and Drug Administration (FDA) published an update to the BioCompute Object Specification Project, which provides much-needed standards for communicating high-throughput sequencing (HTS) computations and data analysis, known as BioCompute Objects (BCOs).
The falling costs of genome sequencing has enabled a greater number of researchers and clinicians to carry out genetic analysis. In fact, 10 new genetic tests reach the market each day. There are many ways in which someone can analyze DNA to look at cancer detection, ancestry, or other areas of interest. Often, the steps taken to analyze next-generation sequencing (NGS) are not communicated sufficiently, making it difficult to understand, compare, or repeat what was done. BioCompute provides a standard framework that helps resolve these issues and removes stumbling blocks for future research. The BioCompute Project’s first document, the Specification Document, was published in September 2017.
“This effort can act as a bridge for research, clinical, and regulatory groups working to help drive personalized medicine,” said Raja Mazumder, PhD, associate professor of biochemistry and molecular medicine at the GW School of Medicine and Health Sciences. “Our newly released ‘BioCompute Specification 1.2’ better enables researchers and clinicians to use this standard for analysis in areas such as the human health, microbiome, agriculture, livestock, synthetic biology, and more.”

Over the last two years, three workshops with over 300 participants have been held to gather input from the researchers and clinicians who would use this standard. Google Cloud recently discussed how it is working with the Global Alliance for Genomics & Health and the BioCompute Consortium to support industry standards for data access, discovery, and cloud computation. Multiple private sector partners have also tested these standards, which have been adjusted based on this feedback. 

“Biocompute objects provide a framework for describing genomic sequencing data analysis that may support the regulatory review of FDA submissions that include NGS data,” said Mark Walderhaug, PhD, Associate Director for Risk Assessment within the FDA’s Center for Biologics Evaluation and Research.  “The concept of BioCompute objects at the FDA was pioneered by Dr. Vahan Simonyan who has since left the FDA.  He and Dr. Mazumder at the GW School of Medicine and Health Sciences have worked with others to endow BioCompute objects with an innovative, harmonizing approach to data sharing designed to satisfy the regulatory and research needs for evaluation, validation and verification of bioinformatics pipelines.  The scientific collaboration with GW helps further the FDA’s public health mission through the efforts to standardize computational and review processes for high-throughput sequencing and next generation sequencing data.”
Efforts have been integrated with groups from DNAnexus, Galaxy Project, Seven Bridges, and more. Next steps include making the BioCompute Object Specification Project into an IEEE and ISO standard.
More information about the BioCompute Project is available at and at

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About the GW School of Medicine and Health Sciences:
Founded in 1824, the GW School of Medicine and Health Sciences (SMHS) was the first medical school in the nation’s capital and is the 11th oldest in the country. Working together in our nation’s capital, with integrity and resolve, the GW SMHS is committed to improving the health and well-being of our local, national and global communities.