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Personal Genomics Comes to US Drugstores

I’ve been writing about personal genomics for years. The standard concept of it is that you can order such genetic tests online, send your saliva or buccal swab to the lab where they analyze your DNA, then you can check online what kind of diseases you have elevated or lowered risk for. That’s how Navigenics, 23andMe or Pathway Genomics works. Now Pathway had a major announcement:

San Diego based startup Pathway Genomics announced today that it will begin selling its DNA collection kits at Walgreens drugstores beginning in mid-May, for about $20 to $30. Unlike a pregnancy test, users won’t be able to get results immediately. They will have to send in their saliva sample and then go to Pathway’s website to select the particular test they want. Users choose from drug response ($79), which assesses how well an individual can metabolize certain drugs, predicting the best dosage for that person or whether they will be susceptible to certain side effects; pre-pregnancy planning ($179), which determines whether parents carry mutations for serious genetic diseases; health conditions ($179), which assesses risk for a number of conditions, including diabetes, Alzheimer’s, prostate cancer and more; or a combination of all three ($249). The kits won’t be sold in New York because the state’s laws require medical professionals to be involved in this type of testing.

As you may know, I’m not totally against direct-to-consumer genetic testing, but I really would like to see doctors and genetic counselors in this process. I think selling such kits through drugstores can only happen in the US right now.

Well the Genomics Law Report blog has an extended and very detailed review about this important topic. An excerpt:

What has changed is their visibility. It is just possible that one of the safest strategies for avoiding regulation – out-of-sight, out-of-mind – played a significant role in the regulation (or lack thereof) of DTC genetic testing. Tests once predominantly available only to early adopters capable of seeking them out online will now begin to appear on the shelves of thousands of neighborhood drugstores nationwide. To a greater degree than ever before, genetic testing will soon be available to mainstream America (and subject to the impulse buy). And that, for better or for worse, may be all that it takes to convince some regulators that the time for action is finally at hand.

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7 Comments Post a comment
  1. HelicalZz #

    Or, maybe not quite so fast. Bloomberg reports that the FDA is going to be looking into the claims Pathway makes on these tests. Don’t be surprised to see some restrictions here.

    http://www.businessweek.com/news/2010-05-14/personal-gene-testing-companies-need-u-s-clearance-fda-says.html

    May 18, 2010
  2. HelicalZz #

    Also, my understanding is that Walgreen’s isn’t going to offer the test quite yet, as the FDA wants some clarification first.

    http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm211866.htm

    May 18, 2010
  3. Anonymous #

    HI Bertalan very nice post on US Drugstore, i reallly liked. and also i completely agree with helicalzz

    May 20, 2010

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