FDA Rethinks Regulatory Approach for Next-Generation Sequencing

Amid President Barack Obama's planned Precision Medicine Initiative, the FDA is evaluating its regulatory approach to next-generation sequencing.

Amid President Barack Obama's planned Precision Medicine Initiative, the FDA 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 writes in a blog post.

The genetic sequencing might be used to predict a person's risk of developing various conditions and might help physicians and patients determine what course of treatment.

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Source: Fierce Health IT