precisionFDA: A Crowd-Sourced, Cloud-Based Platform for Precision Medicine

Posted 06 August 2015 By Michael Mezher

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The US Food and Drug Administration (FDA) has announced the launch of a new crowd-sourced, cloud-based platform, precisionFDA, to enable developers of genomic sequencing diagnostics to share data and methodologies.

precisionFDA

In a post to FDA Voice Wednesday, FDA Chief Health Informatics Officer Taha Kass-Hout and Policy Advisor for the Office of In Vitro Diagnostics and Radiological Health David Litwack laid out the plan and goals for precisionFDA.

The new platform is being jointly developed by FDA's recently formed Office of Health Informatics, which was also behind the highly successful openFDA initiative, and DNAnexus, a California-based company that specializes in data sharing for genomic sequencing. Additionally, the platform is intended to serve the president's recently announced Precision Medicine Initiative.

FDA says it is building this platform to help accelerate the development of diagnostics that use next generation sequencing (NGS) to test for wide ranges of genetic disorders. Because these tests generate so much data and can be used for multiple conditions, they do not fit within the confines of the agency's existing approach for evaluating diagnostics.

By creating an open platform for developers to "test, pilot, and validate new approaches," FDA believes companies will be able to "cross-validate their tests or results against crowd-sourced reference material."

According to DNAnexus, the key objectives of the initiative are:

  • "Exploring the use of a cloud-based portal, precisionFDA, to create a community around open-source genomic analysis pipelines, reference data, and analytical processing resources.
  • Determining appropriate and auditable levels of security, privacy, and governance control to ensure the protection of collaborators’ intellectual property and protected information, while enabling interaction within the community.
  • Providing an initial set of reference genomic data models and reference analysis pipelines.
  • Independent genomic analysis and data management work areas that can be kept private or shared with owner’s choice of collaborators, the public, or FDA for vetting or validation."

Beta Release

As with openFDA, the agency will be launching a platform as a beta, in December 2015. At first, the agency says "precisionFDA's public space will offer a wiki and a set of open source or open access reference genomic data models and analysis tools developed and vetted by standards bodies," before being expanded with crowd-sourced data.

FDA Voice, Press, DNAnexus

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Categories: Biologics and biotechnology, In vitro diagnostics, Regulatory strategy, News, US, FDA

Tags: Precision medicine, openFDA, precisionFDA, Office of Health Informatics, NGS, Next generation sequencing

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