The past, present and future of DTC genetic testing regulation

(Newsweek reporter Mary Carmichael has a DNA dilemma: should she buy a direct-to-consumer genetic test? To help answer that question, she’s recruited people with expertise in various areas related to personal genomics – and a diverse range of opinions about the industry – to address specific areas of concern. At the end of the week she’ll announce her decision.

This post is a brief version of Dan Vorhaus’ response to one of Mary’s questions: how should these tests be regulated? Check out the Newsweek website for other answers to the question, as well as a fantastic extended interview with two senior FDA officials. The full version of Dan’s response is now up at Genomics Law Report.

For other Unzipped contributions to Mary’s project, see Jeff Barrett’s post about risk predictions on Tuesday, and my post on test reliability and the balance between knowledge and fear yesterday. –DM)

The regulation of DTC genetic testing has been consistently characterized as confusing, incomplete and irregularly applied. Recent events – Pathway and Walgreens, a bevy of ominous FDA letters, a Congressional Hearing and a GAO report criticizing DTC genetic tests – indicate that the tide may finally be turning. Yet a brief historical review discloses that DTC has actually been down this road before. A GAO report decrying the evils of DTC genetic testing and a subsequent Congressional hearing? 2010 and 2006. Threatening regulatory letters to DTC companies? 2010 and 2008. DTC genetic testing has faced down the specter of heightened regulation before, and over the long term I am confident it will continue to do so.

Nevertheless, in the short term it is possible that DTC genetic testing will be subjected to a substantially more restrictive regulatory framework. Will DTC continue unchanged while regulators and companies engage in protracted negotiations? Will oversight weed out the ‘snake oil salesmen’ and permit legitimate companies to flourish? Or will it drive all genetic testing (temporarily) out of the hands of consumers?

I cannot advise you to take the test or not, but I can say that if you want to proceed there is no time like the present, for there is no guarantee that the option will still be on the table tomorrow.

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1 Response to “The past, present and future of DTC genetic testing regulation”


  • Dan,
    Great recap. Yes, certainly a crazy 4 years. I do think that everything changed when 23andMe started doing BRCA and PGx testing. It pushed the rest of the field that way. And let’s face it, that is an absolutely medical way, no matter how much fun some VC funded crazy thinks it is.

    -Steve

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