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FDA rethinks regulatory approach for next-generation sequencing

from FierceHealthIT

Amid President Barack Obama's planned Precision Medicine Initiative, the U.S. Food and Drug Administration is evaluating its regulatory approach to next-generation sequencing (NGS). While most diagnostic tests fit the FDA's "one-test, one-disease paradigm" for evaluating a test's analytical and clinical performance, NGS produces a massive amount of data that might require a new approach, FDA Commissioner Margaret Hamburg wrote in a blog post. more

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