DNAnexus
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Biden Announces Major Open Initiatives At Cancer Moonshot Summit
Today, the Cancer Moonshot is hosting a summit at Howard University, in Washington, D.C. as part of a national day of action that also includes more than 270 events in communities across the United States. Vice President Joe Biden will join over 350 researchers, oncologists and other care providers, data and technology experts, patients, families, and patient advocates, among others, will come together at Howard University. They will be joined by more than 6,000 individuals at events in all 50 states, Washington, D.C., Puerto Rico, and Guam. This is the first time a group this expansive and diverse will meet under a government charge is to double the rate of progress in our understanding, prevention, diagnosis, treatment, and care of cancer...
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Bio-IT World Announces the Winners of Its Tenth Annual Best Practices Awards
Bio-IT World announced the winners of its tenth annual Best Practices Awards competition this morning in a plenary session at the 2014 Bio-IT World Conference & Expo in Boston. Grand prize winners were named in five life sciences categories highlighting best practices in clinical trial IT, research infrastructure, bioinformatics, cloud computing and data management from AstraZeneca and Tessella, U-BIOPRED, the Pistoia Alliance, Baylor College of Medicine, and Genentech. Read More »
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DNAnexus to Deliver precisionFDA
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
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 Starts Beta-testing 'The Most Advanced Bioinformatics Platform in the World'
The FDA has started testing the precisionFDA platform it developed with DNAnexus. The closed beta test phase is the precursor to a more widespread rollout of the system, which the CEO of DNAnexus has described as being "the most advanced bioinformatics platform in the world." DNAnexus was enlisted by the FDA to help with the project in August...
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How openFDA's 'Crazy Collision' of Silicon Valley and Federal Culture Is Reshaping the Regulator
Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns from the congressional watchdog, the FDA is now garnering plaudits for its embrace of agile and open development. This new way of thinking is central to--and to an extent responsible for--the recently unveiled precisionFDA initiative. Bio-IT World dug into the genesis of precisionFDA and its implications in a feature this week.
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IT Entrepreneurs Rush Into Healthcare, But Will Human Touch Be Missing?
A new health IT firm called Omada Health, which recently secured $23 million in startup financing, is working with people at risk of developing diabetes to help them head off the full-blown condition...
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Microsoft and Partners Combine the Cloud, AI, Research and Industry Expertise to Focus on Transforming Health Care
...Healthcare NExT, a new initiative to dramatically transform health care, will deeply integrate greenfield research and health technology product development, as well as establish a new model at Microsoft for strategic health industry partnerships. Through these collaborations between health care partners and Microsoft’s AI and Research organization, our goal is to enable a new wave of innovation and impact using Microsoft’s deep AI expertise and global-scale cloud.This initiative includes investments in resources for our partners to capture new opportunities to apply AI to healthcare, such as the Microsoft AI in Health Partner Alliance, an expanding group of partners focused on advancing health technology. Alliance members will receive unique training and access to Microsoft technologies, engineering expertise and data sets. Read More »
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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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