Jonathan Krim Global Technology Editor, The Wall Street
Journal Interview Wed Oct 21st with Theranos Inc. founder and Chief Executive Elizabeth Holmes at
the WSJDLive 2015 conference.
KRIM: You said that the Journals reporting has been
erroneous and is quote grounded in baseless assertions. Could you get specific
on the key points today starting with whether you are now at the point where
you are only testing for one thing herpes using your propriety technology
is that correct?
HOLMES: That is not correct. There are a lot of different
elements of our work that have been conflated through these two pieces. The
decision that we made to voluntarily submit all of our tests and test systems
to FDA meant that we have to move as a company from the lab framework and
quality system to the FDA framework and quality systems.
And our specific recent announcements about what we are
doing with our nanotainer tube have to do only with the tube that we use to
collect capillary or finger stick blood and the decision that we made to take
those tubes through the FDA clearance process, we have submitted all of our
filings around those nanotainer tubes. The nanotainer was actually cleared by
the FDA for use with our devices and software for the first test that we took
through the FDA for HSV and now we are taking it through for use with any
combination of tests.
So once you submit those submissions at a certain point if
you are going to transition from operating under the CLEA lab framework to the
FDA framework to be compliant with the use of those nanotainers as a FDA
regulated device you have to move to the FDA quality systems and that is what
we have just done.
KRIM: So at this point you are not using the nanotainer for
anything except then the HSV Test?
HOLMES: The nanotainers – you said technology initially and
Theranos has a lot of other technology which is our devices and software and
chemistries that have nothing to do with the decision to transition the tube.
KRIM: So are you testing for other medical conditions using Edison?
HOLMES: So Edison is a code name that we had for one of our
earliest versions of our devices. Theranos has many proprietary devices that we
develop and manufacture ourselves what is being referred to as Edison is one of
them. So we don’t actually use the technology that is referred to as Edison and
haven’t for a few years now.
KRIM: So if I went to one of the centers and got a finger
prick and I only gave that much blood What tests are you currently able to
perform for that blood using anything other than commercially available lab
equipment?
HOLMES: So we have never used commercially available lab
equipment for finger stick based tests. Every finger stick based test we have
ever done uses proprietary Theranos technology that is not commercially
available.
Right now because we are at a moment in time in which we
have decided to transition from the lab framework to the FDA framework, I think
about this kind of like you have cars driving on a road and you say I am going
to take everyone from driving on the right side of the road to the left side of
the road the only way to do that is to pause and cut over.
So as a result, because we have voluntarily decided
not to use our nanotainer tubes until we cut over to the let hand side of the
road which we now have the FDa quality systems in place we are not collecting
the finger stick sample for anything HSV that has nothing to with what we can
run on our devices has nothing to do with our tests or our testing methodology
or the accuracy or the performance of it
http://on.wsj.com/1ZXJrUk
Video
http://blogs.wsj.com/digits/2015/10/21/theranos-ceo-elizabeth-holmes-goes-on-stage-at-wsjdlive-2015-live-blog/#commentform
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