Volume 93 Issue 26 | pp. 10-13
Issue Date: June 29, 2015

Cover Story

Companion Diagnostics And Drugs Follow New Regulatory Path

Instrumentation and pharmaceutical firms go down the road together to develop diagnostic and drug combinations
Department: Business
Keywords: instrumentation, diagnostics, oncology, pharmaceuticals, genomics, sequencing

Last summer, the Food & Drug Administration published its final guidance on the development and approval path for companion diagnostics. These in vitro tests and devices put personalized medicine into practice by providing, FDA says, the “information essential for the safe and effective use of a corresponding drug.” In clinical trials and medical care, the diagnostics will help identify patients most likely to benefit from a particular therapy.

FDA approved . . .

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