Regarding the recent news that Theranos has stopped its finger-prick tests due to an FDA request, Holmes said that had nothing to do with the quality and veracity of their tests. Instead, she said they're simply pausing as they've decided to submit its finger-prick blood test process for FDA approval. Right now, they're transitioning from a normal lab framework to one with FDA quality standards. "The nanotainer was cleared by the FDA to use," she said. "We got our systems cleared by the FDA at the end of July." The FDA did drop by unannounced for an inspection, but she said it was about quality systems regulations and not about methodology or testing. Holmes said that the FDA standard is one that few other labs are embracing and is proud that Theranos is taking this extra step.
"When we do venous draws [blood drawn through veins], we use commercially available machines. When we do finger-stick, we use technology that's proprietary," she said, addressing the accusations of former employees. "We have never used commercially available equipment for finger-stick tests. Every finger-stick test uses proprietary Theranos technology that's not commercially available." As for the claim that Theranos has diluted those finger-prick blood tests to use on commercial machines, Holmes said this isn't even possible. They do dilute blood samples sometimes, yes, but only when they're developing an assay, which is a test to figure out the quality and quantity of a substance component.
As for the disgruntled customers complaining about inaccuracies, Holmes said that those cases have to be looked at individually on a case-by-case basis, as there might be extraneous circumstances that could affect the results. "You can't take one person and make a generalized statement." She also took the Journal to task for emails that she said were quoted out of context and inaccurate sources.
One of the other issues around Theranos is that it demonstrates the performance of its tests through accredited proficiency tests, rather than peer-reviewed journals. The reason? "If you're trying to work on 120 FDA submissions at the same time, you don't have much time to sleep," she said. She's open to peer review further down the line. "Theranos is a clinical lab," Holmes said. "We're regulated by everybody ... We have recurring audits from all our regulators. They look at how we do proficiency tests, they look at all our submissions."
"We've done 3.5 million tests. We have tens of thousands of people who have rated our service," she said. "We know the integrity of what we've done."
Update: The Wall Street Journal has issued a response to Holmes, stating that none of its reporting has been inaccurate despite her assertions.
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.
We note that Ms. Holmes sought to challenge the reliability of our sources, but it remains the fact that she doesn't know from whom the information for our articles was gathered. We assure her and our readers that our sources were well positioned to know the information they provided about Theranos, and they were vetted before publication.
The Journal reiterates that our articles about Theranos were thoroughly reported, fair and wholly accurate.
Update 2: Theranos has also responded with its own statement, which prompted WSJ to amend its earlier statement.