[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

[BillK]

On Tue, Nov 26, 2013 at 6:59 AM, Brian Manning Delaney  wrote:
> Possible viral -- actually, mainstream media... -- falsehood warning. The
> FDA letter (http://www.fda.gov/.../WarningLetters/2013/ucm376296.htm) as I
> read it, only orders 23andMe to stop marketing the saliva collection kit.
> ("23andMe must immediately discontinue marketing the PGS until such time as
> it receives FDA marketing authorization for the device.") Is marketing it
> (for a particular purpose) the same as /selling/ it (without mentioning
> said, or any, purpose)? Doesn't seem like it, but I'm no expert in
> regulatory law.
>

'Marketing' as the FDA regulations use the term, means 'Offering for sale'.

The letter orders 23andMe to stop selling the Saliva Collection Kit
and Personal Genome Service (PGS) until approved by the FDA.

The FDA said the company repeatedly has failed to provide the
scientific data necessary to prove that its test works as advertised.
In its letter, which was dated Nov. 22 but posted online Monday, the
FDA said it was concerned about 23andMe’s direct-to-consumer test
“because of the potential health consequences that could result from
false positive or false negative assessments,” which could lead people
into unnecessary or ineffective treatments. The agency also said that
the company had failed to support its claims despite “more than 14
face-to-face and teleconference meetings” with FDA officials, as well
as “hundreds of e-mail exchanges” and “ample detailed feedback.”

<http://www.washingtonpost.com/national/health-science/fda-warns-maker-of-genetic-testing-kit/2013/11/25/7a778aa4-55ef-11e3-835d-e7173847c7cc_story.html>
-------------

So 23andMe now have to prove that their tests actually work. If they
say a subject is at risk of a disease, they have to prove it.


BillK