Is Your Shop Into Theranostics? So is The FDA. Here is How They Can Help | GenomeWeb

Molecular diagnostics companies eager to develop theranostics programs have regulatory agencies to navigate, reimbursement policies to fret over, finicky health-care providers to woo, and even ignorant drug makers to tutor.

But these companies may find help from an unlikely source: Steve Gutman, director of the US Food and Drug Administration’s Office of In Vitro Diagnostic, Device Evaluation and Safety, who has intimated that drug/diagnostic combinations — so-called Dx/Rx companions, or theranostics — have a strong future ahead of them.

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