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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

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.