As next-gen sequencing-based diagnostic tests are making their way into the clinic on multiple fronts, the US Food and Drug Administration is involved in developing processes to evaluate them, with the intent to regulate NGS-based tests eventually.

At the Advances in Genome Biology and Technology conference in Marco Island, Fla., last week, Zivana Tezak from the FDA's Office of In Vitro Diagnostics and Radiological Health offered some insights into the agency's initiatives and intentions around ultra high-throughput sequencing.

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