Gloved hand holding a vial.

The Food and Drug Administration (FDA) is prepping a new cloud-based computing tool called HIVE (High-Performance Integrated Virtual Environment) in order to handle what it expects will be “massive amounts of data from submissions employing next-generation sequencing (NGS),” according to published news reports. The agency expects to receive an increasing number of applications for medications, devices, and companion diagnostics that use NGS, as NGS becomes more popular.

“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 to transfer it to other computer systems,” according to an FDA Voice blog post written by Carolyn A. Wilson, PhD, associate director for research at the FDA’s Center for Biologics Evaluation and Research (CBER).

FDA developed HIVE in order to assess the interpretation and significance of data included in regulatory submissions that involve NGS. CBER supported the development of HIVE, a “private cloud-based environment that comprises both a storage library of data and a powerful computing capacity” and can “consume, digest, analyze, manage, and share all this data,” Wilson wrote.

HIVE is already proving useful. The HIVE-hexagon aligner is an algorithm that enables CBER’s scientists in the Office of Vaccines Research and Review to investigate the genetic stability of influenza A viruses that are used to make vaccines. “The scientists showed that this powerful tool might be very useful for determining if influenza viruses being grown for use in vaccines were accumulating mutations that could either reduce their effectiveness in preventing infections, or even worse, cause infections,” Wilson wrote. HIVE also holds promise to help scientists study gene variations that can affect how they work, or even make them stop working, which may eventually help doctors alter patient care to reflect individual differences.

Research into HIVE notes the benefits of using the system. “Experiments have shown HIVE-hexagon is more sensitive and faster than current industry standard alignment algorithms due to scalability, high parallelizability, non-redundification, dynamic matrix linearization and implicit and explicit cross-similarity usage. There is already a great deal of interest surrounding HIVE-hexagon, and HIVE plans to continue developing this and other new tools to further promote the advancement of NGS technologies and the larger field of genomics,” according to an article published in PLOS One.

HIVE has been so successful for CBER that the agency now plans to work with the FDA’s Center for Devices and Radiological Health (CDRH) to implement “with greater capacity and computer power that takes advantage of the high-performance computing capacity there,” Wilson wrote on the FDA’s blog. “When ready and approved by FDA for use, we will use this powerful, CBER-managed, inter-center resource to handle regulatory submissions.”

Read Wilson’s blog post, and see the PLOS study.