The burgeoning industry built around telling patients how their genes may interact with specific drugs has lately been in turmoil, the result of confusion and uncertainty about what exactly regulators will allow these genetic test makers to report.

On Thursday, the Food and Drug Administration offered some new clarity into its expectations for such tests.

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  • We have long known the general overall role played by metabolism. Too fast a metabolism and the efficacy of the drug may be reduced. Conversely, “poorly metabolized” can result in drugs whose uptakes and half-lives are undesirable- too much of a good thing.

    It is vital that we move toward prescribing for the patient and not simply the diagnosis. This research and publication by FDA is an important step but we remain fairly devoid of inexpensive, mainstream ways to know if John Doe needs “x” amount of Amlodipine v. Sally Parker’s requirements.

    Are we doing harm without routine access to patient-specific metabolic profiles to inform prescribing? Likely, yes, but unintentionally as the state-of-the-art remains more …. primitive than we’d like.

    We’ll get there though. Of that I’m confident. Watch life expectancy increase then and hopefully quality-of-life too.

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