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.

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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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