The closely watched and immensely private Silicon Valley start-up Theranos has been put on the spot following the publication of articles in The Wall Street Journal (WSJ) that explored the novelty and accuracy of Theranos' blood testing technology.
Theranos' 31-year-old founder, Elizabeth Holmes, is currently fighting a very public fight to preserve not just her reputation but Theranos' as well. She took the stage at the WSJDLive 2015 conference, WSJ's annual digital conference, on Oct. 21, 2015 in Laguna Beach to discuss her company and the surrounding controversy.
At the conference, Holmes confirmed that Theranos is currently in a 'pause period' as they seek approval from the Food and Drug Administration (FDA) for their proprietary blood testing technology.
"We have to move, as a company, from the lab framework and quality systems to the FDA framework and quality systems," said Holmes. When asked about the WSJ articles, she said, "I read what was written in the article. We disagree with it. We think it was false, and we think it was misleading." Moreover, she challenged the authenticity of the sources that were left unnamed in the WSJ articles.
WSJ published a press release following Holmes' segment at the WSJDLive 2015 conference which said the Theranos CEO didn't say anything that refuted the accuracy of the WSJ articles "which were subject to the Journal's rigorous and careful editing process".
Holmes is gearing up for the release of a 16-page document that refutes the WSJ articles 'point-by-point'. The 16-page document will bear a closing argument that the WSJ author's agenda includes one that considers Theranos "a target to be taken down." Holmes' rebuttal document will also dissect the agenda of the people quoted in the WSJ articles.
Despite the drama surrounding Holmes and Theranos, the company has no immediate plans to publish peer-reviewed data in any medical journals to prove the accuracy of their lab tests compared with established blood testing laboratories. Holmes explained that they have 'never been against peer review'. Instead, their FDA submissions would be the 'studies' that they were working on.
Holmes expressed that organizations testing Theranos' product might publish papers eventually, but Theranos is currently focused on securing government approval for their tests. The test for herpes simplex 1 virus has been cleared by FDA in July.