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
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