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BioWorld - Saturday, December 13, 2025
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Home » FDA's Litwack: biggest concern for NGS is specific intended use
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FDA's Litwack: biggest concern for NGS is specific intended use

Feb. 23, 2015
By Mark McCarty
Massively parallel genetic sequencing systems offer much, but among the things they offer is large list of difficult questions, some of which were tackled in a Friday meeting on next-generation sequencing (NGS) systems. David Litwack, of the FDA's personalized medicine staff, ticked off a few concerns at the agency, including the fact that "we can't predefine what a test will find analytically." He said the biggest issue, in his view, is "the lack of a specific intended use" for such systems.
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