A new genre of diagnostic tests for the era of personalized medicine

Celia Henry Arnaud, C&EN senior editor, points out that the U.S. Food and Drug Administration has approved several precedent-setting cancer drugs that provide a glimpse of the “personalized” medical care that awaits patients with cancer and other diseases in the future.

Personalized medicine involves selecting treatments that work best with the set of genes present in each individual person. Such treatments work only for patients with conditions related to mutations, or alterations, in certain genes.

The article describes new “companion diagnostics,” or diagnostic tests that already have gone into use, with more on the horizon, to identify patients most likely to benefit from a medication. Doctors must perform these tests before starting treatment. Arnaud describes how pharmaceutical companies are embracing an approach that involves co-development of drugs and companion diagnostics that can be used in clinical trials and later when a medication goes into general use.

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