|Theranos CEO Elizabeth Holmes|
Embattled Theranos CEO Elizabeth Holmes escalated her feud with The Wall Street Journal at the publication's WSJD Life conference, telling the crowd, "I've never seen The Wall Street Journal as a tabloid magazine."
"I read what was written in the article," Holmes said during her 30-plus-minute Q&A session, according to Wired. "We disagree with it. We think it was false. And we think it was misleading."
Holmes said the pause in its finger-prick blood test was a voluntary move made during the transition to the FDA's more rigorous diagnostics industry regulations. In a follow-up to their exposé, the WSJ claimed the stoppage was made under pressure from regulators.
But Holmes explained that, "If you have cars driving on a road and I'm going to take everybody 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."
It's worth noting that other companies are likely making a similar transition away from the CLIA rules to FDA's quality-control system as the agency prepares to finalize guidance that will make it the chief regulator of the industry, ending the current two-track system.
That gives her explanation more credibility, but the WSJ's central concerns about the lack of accuracy of Theranos' test have been anecdotally verified by others who took the test personally, such as VC and ex-Apple executive Jean-Louis Gassée.
In addition, Business Insider reports that Google Ventures decided not to back the company after encountering lots of "handwaving" over the company's secretive technology, such as Edison. The company sent an employee to have their blood tested and discovered that the so-called nanotainer which requires just a drop of blood was not used. The employee turned down an offer to receive a traditional venous blood draw instead.
In a statement, Theranos released a point-by-point rebuttal of the WSJ's claims.
For example, the release says: "The reporter writes that 'Lab experts say finger-pricked blood samples can be less pure than those drawn from a vein because finger-pricked blood often mixes with fluids from tissue and cells that can interfere with tests.' This is misleading: With each FDA filing, Theranos is showing that our finger-stick tests are just as accurate as venous draws, starting with our first FDA clearance this summer."
And: "The article implies that Theranos' proprietary devices were only capable of running a limited number of tests. First, 'Edison' is only one of many proprietary devices used as part of Theranos proprietary technologies. In total, Theranos research and development has developed hundreds of tests for finger-stick samples using our proprietary devices."
Meanwhile, the WSJ released a statement claiming, "Nothing said at the conference by Ms. Holmes refutes the accuracy of the reporting done by John Carreyrou or of the articles, which were subject to the Journal's rigorous and careful editing process. Contrary to Ms. Holmes's claims, the Journal shared all facts and anecdotes published in the articles with Theranos before publication, in accordance with our longstanding editorial practice and principles. The company was given plenty of opportunity to respond. Ms. Holmes declined interview requests from the Journal for more than five months, but the general counsel and outside counsel of Theranos provided significant input, which was fairly reflected in the articles."
Interest in the Theranos saga has reached sky-high levels, in large part due to its iconic billionaire founder Elizabeth Holmes, who is famous for her all-black attire.
In his essay, Jean-Louis Gassée called Holmes "quintessential Silicon Valley." She's certainly been successful, at least financially, but Gassée leaves unanswered the question of whether the development of an overhyped (but still potentially useful) technology is part of what makes her typical of the Valley too, as several are claiming, perhaps cynically.
Perhaps the FDA will play the role of judge. Holmes has promised to submit all its myriad tests for FDA clearance or approval. So far, it has earned permission to conduct a herpes test using its nanotainers.
Special Report: Top women in medical devices 2014 - Elizabeth Holmes, Theranos