Today, the FDA announced the beta release of precisionFDA, a community platform for NGS assay evaluation and regulatory science exploration. The online , cloud-based, portal will allow scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind a method of “reading” DNA known as next-generation sequencing (or NGS). precisionFDA is the FDA’s answer to its role under the White House’s Precision Medicine Initiative.
Harnessing the Power of Next Generation Sequencing
Next Generation Sequencing (NGS) allows scientists to compile a vast amount of data on a person’s exact order or sequence of DNA. Recognizing that each person’s DNA is slightly different, scientists can look for meaningful differences in DNA that can be used to suggest a person’s risk of disease, possible response to treatment and assess their current state of health.
In August, DNAnexus, the provider of cloud-based genome informatics and data management was awarded a research and development contract by the FDA to build the platform. The precisionFDA platform is a part of this larger effort and through its use we want to help scientists work toward the most accurate and meaningful discoveries. precisionFDA users will have access to a number of important tools to help them do this.
These tools include reference genomes, such as “Genome in the Bottle,” a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. Users will also be able to compare their results to previously validated reference results as well as share their results with other users, track changes and obtain feedback.
“The precisionFDA platform is a part of this larger effort and through its use we want to help scientists work toward the most accurate and meaningful discoveries. precisionFDA users will have access to a number of important tools to help them do this. These tools include reference genomes, such as “Genome in the Bottle,” a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. Users will also be able to compare their results to previously validated reference results as well as share their results with other users, track changes and obtain feedback,” said Taha Kass-Hout, MD, FDA’s chief health informatics officer in the announcement.
