15th Anniversary Essay: Regulation Then and Now

In the fifteen years since the founding of IVD Technology, the IVD industry-and its regulation by FDAhave both changed. The diagnostic capabilities of IVDs have improved dramatically during that period. Some of the advances, such as high-speed, lower-cost genomic sequencing, seemed like the stuff of science fiction when IVD Technology was first published. The number of diagnostic uses has mushroomed during that same period, and IVDs are playing an increasingly important clinical role. Even after discounting the hyperbole, IVDs may help reshape some areas of medicine, such as oncology, by enabling individualized therapy.

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