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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

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.