Regulatory Focus™ > News Articles > For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’

For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’

Posted 03 October 2016 | By Zachary Brennan 

For Developers of New Genome Sequencing Analytical Tools, FDA Launches ‘App-a-Thon’

The US Food and Drug Administration (FDA) on Monday launched what it’s calling an “App-a-Thon,” inviting software developers to get together and add next-generation sequencing (NGS) software apps to the precisionFDA app library.

The challenge, which closes 28 October 2016, is looking to engage the NGS community in the development of new genome sequencing analytical tools for use on precisionFDA, which is an online research portal for NGS assay evaluation and regulatory science exploration.

precisionFDA’s task, according to Zivana Tezak, associate director for Science and Technology at FDA’s Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health and Elaine Johanson, precisionFDA project manager, is to advance the use of NGS by drawing on the latest computing and storage technologies to provide an open source cloud-based space where experts can share data, ideas and methodologies.

The “apps” the agency is looking for in this challenge, which it defines as “executable commands using the Linux operating system that are ‘wrapped’ around NGS software,” should be intended to perform simulations, benchmarking, data integration, mapping portions of the genome or identifying genetic variants that members of the precisionFDA app library can run.

“Our goal is to build a robust reference library of apps and files so that precisionFDA can provide developers with everything they need to support development work on their software pipeline or tests,” Tezak and Johanson write.

The results of this challenge will be highlighted by FDA Commissioner Robert Califf at the World Precision Medicine Congress on 14 November 2016 in Washington, D.C. 

App-a-Thon in a Box


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