Since the initial approval of Herceptin ten years ago, it has become the poster child for personalized medicine. But for almost as long as the drug has been on the market there have been questions about the diagnostics used with the drug and the degree to which they correlate with clinical response. Spurred by testing guidelines in 2007, there's a new-found focus on the nitty-gritty of laboratory conduct and test concordance that could serve as a useful model for addressing the broad issues of drug-diagnostic convergence.
Mark L. Ratner
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