The already long and expensive process of bringing a drug from discovery to market is further challenged by the entrance of personalized medicine products, which don't neatly fit into industry's existing business models or the US Food and Drug Administration's regulatory pathways.

Genomically guided personalized medicine products have so far emerged most readily in oncology. But even drug and diagnostics companies developing genomic medicines in the cancer space have experienced setbacks due to regulatory and market challenges.

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The Kansas City Star examines issues surrounding newborn genome sequencing.

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