precisionFDA

See the following -

DNAnexus to Deliver precisionFDA

Press Release | DNAnexus | August 5, 2015

DNAnexus, the leader in cloud-based genome informatics and data management, today announced that the company was awarded a research and development contract by the U.S. Food and Drug Administration’s Office of Health Informatics to build precisionFDA, an open source platform for community sharing of genomic information. precisionFDA is a new approach for evaluating bioinformatics workflows, and is an integral part of the agency’s work in understanding diagnostic tests that incorporate next generation sequencing (NGS) technologies. FDA’s role under the White House’s Precision Medicine Initiative is to review the current regulatory landscape and develop a streamlined approach to evaluating NGS-based diagnostics.

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FDA Hits Tight Timeline for Start of precisionFDA Open Beta

Nick Paul Taylor | FierceBiotechIT | December 21, 2015

FDA has hit the tight timeline it set itself for the start of the precisionFDA open beta program. The system went live this week, just as the regulator forecast when it started a closed beta program last month. Taha Kass-Hout, chief health informatics officer at FDA, committed to trying to have precisionFDA ready for testing by the end of the year back when the regulator first outlined the project in August. That Kass-Hout was willing to aim for such a timeline--which at the time he described as being "very, very tight"--and then went on to achieve it is testament to the new approach the regulator is taking to IT projects.

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FDA Issues RFQ for Large Scale EHR Study - Wants to Leverage VA's Open Source VistA EHR and Database for Research

The Food and Drug Administration (FDA) yesterday issued a Request for Quotation (RFQ) for a large-scale electronic health record (EHR) system. This RFQ is very important as the objective is to develop a platform to support a critical project by the FDA's Division of Bioinformatics and Biostatistics (DBB) "to conduct research to assess the safety and surveillance of FDA regulated products through the FDA adverse event reporting systems..." Adverse drug reactions are one of the leading causes of death in the US, thus finding which drugs cause negative interactions is of vital importance. The project requires "use of the large electronic medical record (EMR) system..." The project is going to leverage the largest, most comprehensive, and clinically relevant medical records database, that of the US Department of Veterans Affairs (VA).

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FDA to Advance Precision Medicine by Enabling Open Source Collaborative Informatics

FDA plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. Yet while more than 80 million genetic variants have been found in the human genome, we don’t understand the role that most of these variants play in health or disease. Achieving the President’s vision requires working collaboratively to ensure the accuracy of genetic tests in detecting and interpreting genetic variants. We are working towards that goal by developing an informatics community and supporting platform we call precisionFDA.

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Obama Administration Announces Key Actions to Accelerate Precision Medicine Initiative

Press Release | The White House | February 25, 2016

A year ago the President announced the launch of the Precision Medicine Initiative to accelerate a new era of medicine that delivers the right treatment at the right time to the right person, taking into account individuals’ health history, genes, environments, and lifestyles. Precision medicine is already transforming the way diseases like cancer and mental health conditions are treated. Molecular testing for cancer patients lets physicians and patients select treatments that improve chances of survival and reduce adverse effects...

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PrecisionFDA: A Community Approach For Submitting & Evaluating Diagnostic Tests

DNAnexus has been awarded a research and development contract by the FDA’s Office of Health Informatics to build precisionFDA, an open source platform for community sharing of genomic information. precisionFDA is a new approach for evaluating bioinformatics workflows, and is an integral part of FDA’s work in better understanding diagnostic tests that incorporate next-generation sequencing (NGS) technologies. As a component of the White House’s Precision Medicine Initiative, precisionFDA’s streamlined approach to evaluating NGS-based diagnostics and creation of reference datasets will build a community around best-practices resources and democratize the submission process to the FDA.

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