Pre-Holiday FDA $99 Pot Boiler: Maybe I Should Have Done More Due Diligence. . . [Sorta’ On, and Off, Topic]

Okay — I’ll admit it — along with my daughter, I’ve become a customer, here — we each spat into sterile test-tubes, and shipped our DNA off to a company run by one Anne Wojcicki, the wife of probably the best known of the Google founders, one Sergey Brin. That was a few weeks ago.

Now I am bemused to read — (on the front page of the Gray Lady, no less!) that the company has no FDA clearance for the kits. I am also learning that some of the company’s materials purport to make medical dianoses and causual predictions — or at least, nearly purport to do so. Even so, I am still keenly interested in whatever the tests turn up about my ancestry, looking back ten or more generations.

So — I am conflicted: I don’t want my $99 back; I was prepared to discount a fair bit of the purported medical information, in any event. I do want to know what my chromosomes might tell me — or even hint at — about the roots of our family tree still buried by a deep, peaty bog, and then further enshrouded by the mists of time long settled, and our forebears’ only oral traditions — now forever silenced, in the same bog.

I for one am hoping that the results already in process at 23& will be mailed out. Here’s a bit of the New York Times story — and the FDA warning letter, below the slug line in the pull quote:

. . . .In a scathing warning letter that the agency posted on its website on Monday, it said that 23andMe had failed to provide adequate evidence that its product, Personal Genome Service, provided accurate results.

“F.D.A. is concerned about the public health consequences of inaccurate results from the P.G.S. device,” the agency said in its letter.

Of the personal genome testing companies, 23andMe may be the best known, in part because it is backed by Google. The company is also run by Anne Wojcicki, the wife of a Google founder, Sergey Brin, though they are separated.

Its $99 test is sold only through the company’s website, and has been used by about half a million people. It analyzes the DNA in a saliva sample to tell consumers, among other things, whether they might be at a higher or lower risk of developing certain diseases. . . .


[11.22.13 FDA Warning Letter:]

. . . .Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. . . .

Fascinating. I will update this, as I learn more — and receive my results — as my view is that I have a contractual right to them. I’ve paid for them — I’d like to see them. My understanding is that the company is using third party contractor labs to generate the reports, and my strong suspicion is that each of those labs have appropriate FDA paperwork. I suppose the kit could have been so poorly packed as to be contaminated upon delivery — though it surely didn’t looks to be so. This will be a fun little side story, here.


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