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For precision medicine to take root, diagnostics also have to be precise. But so far, there isn’t a ton of confidence about the reliability of next-generation sequencing tests. So the Food and Drug Administration is pressing ahead with an ambitious effort to bring order to the chaotic world of DNA sequencing.

“The only way we’re really going to move quickly on these new technologies is to collaborate with experts globally,” said Elaine Johanson, acting director of FDA’s Office of Health Informatics.


The FDA does not put most such diagnostic tests through the approval process; they’re largely exempt from regulatory oversight. Instead, the agency is pushing software developers to voluntarily put their algorithms through a review process. Through an initiative called precisionFDA, launched in 2015, the agency has, in a sense, gamified the effort, launching app-a-thons and community challenges designed to test how accurately — and how consistently — various tests analyze and interpret genetic data.

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  • I agree with 2 first paragraph content and the FDA’ Acting Director Elaine Johanson.
    The global vaccine development efforts brought to light discrepancies in HIV vaccine efficacy among various demographics, involving among other; geographic location, environment, race Types and other differences.
    DNA sequency is multi-factorial EXTERNALLY dependent: sequencing platforms, analytical software, statistical models used, clinical criteria, methods, process control validation and acuaracy.
    From the inside an individual’s DNA is a moving target, real-time affected by environmental, emotional nutritional, medicinal and socio-economic added factors.
    Aside from listed above, I see this huge global happy effort, accommodating to all variables, thresholds and finite analytics. “Pressure driven efforts to Capture Data from new or existing global sample banks, to sequencing, analysis and Diagnostics.”

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