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Preparing for the Data Flood

With a new cloud-based tool dubbed HIVE, the US Food and Drug Administration is readying itself for the onslaught of next-generation sequencing data that will soon be included in many regulatory submissions, the FDA Voice blog says.

"This technology produces sets of data that are so large and complex that they overwhelm the ability of most computer systems to store, search, and analyze it, or transfer it to other computer systems," Caroline Wilson, the associate director for research at FDA's Center for Biologics Evaluation and Research, writes.

According to Wilson, HIVE, which is short for High-Performance Integrated Virtual Environment, "can consume, digest, analyze, manage, and share all this data."

One algorithm, termed HIVE-hexagon aligner, has enabled researchers in the Office of Vaccines Research and Review examine whether the influenza A viruses used to make vaccines are genetically stable or if they are accumulating mutations that might interfere with their ability to prevent infections.

Wilson adds that CBER is currently working with the Center for Devices and Radiological Health at FDA on a second HIVE installation with even greater capacity and compute power. "When ready and approved by FDA for use, we will use this powerful, CBER-managed, inter-center resource to handle regulatory submissions," she says.

The Scan

Study Tracks Off-Target Gene Edits Linked to Epigenetic Features

Using machine learning, researchers characterize in BMC Genomics the potential off-target effects of 19 computed or experimentally determined epigenetic features during CRISPR-Cas9 editing.

Coronary Artery Disease Risk Loci, Candidate Genes Identified in GWAS Meta-Analysis

A GWAS in Nature Genetics of nearly 1.4 million coronary artery disease cases and controls focused in on more than 200 candidate causal genes, including the cell motility-related myosin gene MYO9B.

Multiple Sclerosis Contributors Found in Proteome-Wide Association Study

With a combination of genome-wide association and brain proteome data, researchers in the Annals of Clinical and Translational Neurology tracked down dozens of potential multiple sclerosis risk proteins.

Quality Improvement Study Compares Molecular Tumor Boards, Central Consensus Recommendations

With 50 simulated cancer cases, researchers in JAMA Network Open compared molecular tumor board recommendations with central consensus plans at a dozen centers in Japan.