As part of President Obamas Precision Medicine Initiative, the Food and Drug Administration plans to launch a crowd-source platform to help develop standards for next generation testing technology that quickly sequences a persons genome.
Planned for beta release in December, precisionFDA will offer researchers and test developers access to a secure cloud-hosted work space where their software code or data can be shared with collaborators, FDA, or even the public, if they so choose. According to the regulatory agency, precision medicine requires working collaboratively to ensure the accuracy of genetic tests in detecting and interpreting genetic variants.
Taha Kass-Hout, M.D., FDA chief health informatics officer and director of FDAs Office of Health Informatics, says precisionFDAs 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, such as the National Institute of Standards and Technology.
The crowd source approach we hope will advance the science and ultimately make it a lot easier for people to validate their tests in ways that are producible and transparent, says Kass-Hout.
DNAnexus, a cloud solutions vendor for the genomics industry, has been awarded an $849,678 research and development contract by the FDAs Office of Health Informatics to build the open source platform for community sharing of genomic information, providing the underlying cloud-based compute and data management infrastructure.
The Mountain View, Calif.-based company expects the platform will be used broadly by test providers, standards-making bodies, pharmaceutical and biotechnology companies, healthcare providers, academic medical centers, research consortia, and patient advocacy groups.
We predict that this new model for evaluating next generation sequencing-based tests will open up the process to a broader range of community members, who will benefit from open source reference data and applications and pay-for-use compute and storage resources, leveling the playing field for smaller test developers, according to a written statement from DNAnexus.
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