The FDA May Block All Genetic Test Kits

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Walgreens plans to sell genetic testing kits for the first time in brick and mortar stores, but the FDA thinks this shift from labs/internet to pharmacy may be too much too fast.


The FDA has issued a warning to Pathway Genomics following their announcement to sell their saliva-based genetic tests in thousands of Walgreens stores, advising the company to first submit data proving its tests offer accurate results, lest the FDA exercise its rights to pull the kits off shelves.

(Incidentally, the kits themselves would only sell for $20-30, but the results can cost as much as $250.)

However, the plot thickens with an anonymous tip given to the Sun-Times, that the FDA was considering similar action with internet-based genetics tests, too, like Navigenics and 23andme. In other words, the FDA could put its foot down on home-based genetics testing for the first time, stopping a whole, growing industry right in its tracks.

While we hate to see progress slowed, the FDA may actually be protecting our interests more than we may imagine. Not only have we found such testing's limited results to be absurdly confusing; the impact of one's genetic information on many types of insurance is still unknown.

Then again, the FDA's threats seem a bit more reactive than proactive. How did they not see this day of reckoning coming sooner? [Chicago Sun-Times]




I know of more than one person per day running into the emergency department in a panic when the take-home pregnancy test they bought at a drug store is not the result they expected.

I can only imagine the absolute droves of people going to their doctors because they tested positive for some werido gene with these kits.

Many of those people, by the way, will not have primary care insurance and will surely cram into the ER. "Doctor! Doctor!" they will cry, "I have the baldness/fatness/forgetfulness/cancer-of-this-or-that gene! I need a prescription!"

Good luck with that.