Friday, November 2, 2018

Here’s The Thing About Those "Direct To Consumer" Genetic Information/Tests: Recent FDA Approvals, And Warnings...


Regular readers have long known that (on the wise advice of my eldest daughter) I became an early adopter of 23andMe's DNA testing -- even prior to any FDA review/approval.

We have been following that company, and the whole field of "DIY DNA kits" since early 2013. Now comes word that my favorite company in this field (treating it all as responsible scientists should) Wednesday received FDA approval to give consumers reliable information about their predispositions to absorb various on-market drugs -- for CV risks, depression and some infectious diseases.

As with any "consumer level" medical information, one should always speak with a doctor before irretrievably acting on it (regardless of FDA approvals) -- but I do regard this as a useful addition to the kit's arsenal.

At essentially the same time, FDA staffers warned about unapproved companies like Color Genomics (we've mentioned this price gouging company before), that claim to offer a similar service -- without FDA review -- and overprice the tests ($750 a kit at Albertson’s — vs. $99 from the FDA approved leader, offering a wide array of additional reports, gratis). Here's a bit from Business Insider, yesterday:

. . . .Wednesday, Wojcicki's company [23andMe] got the green light from the Food and Drug Administration to sell such a test. The next day, experts from the same agency warned people against using similar tests "whose claims have not been reviewed by the FDA."

23andMe's test is the first of its kind to get FDA clearance to be sold directly to consumers online or in stores. Several other similar tests are on the market, but all require the involvement of a physician or a psychiatrist. . . .


We think this is an area -- if responsibly priced -- that will better inform human health care decision-making. Now, this weekend, for our part, we will be all over the middle of the nation -- knocking on doors in Tennessee, Indiana and maybe even Iowa -- through Monday -- pushing forward a blue tsunami. But primary focus will be ending Marsha Blackburn's run for a Senate seat. Onward -- grinning. Ever. . . grinning.

नमस्ते

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