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FDA Finalizes Guidelines To Promote Next-Gen Sequencing Technology

The promise of next-generation sequencing technology to help patients understand risk and target treatment for disease is high. US FDA is hoping to help accelerate practical advancements with the release of two final guidances addressing NGS technology and databases that aggregate genomic information.

DNA & RNA

US FDA has finalized a pair of guidances that the agency hopes will spur development of databases that aggregate genomic data and advance the promising new diagnostics field of next-generation sequencing (NGS). The complementary guidances outline the agency's thinking on what sponsors need to consider when submitting pre-market applications for NGS tests and the databases that could be used to support the submissions.

FDA hopes the guidances could help revolutionize how patients are diagnosed with hereditary diseases or considered to be at higher risk for certain conditions

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