Elizabeth Holmes, CEO of blood testing startup Theranos, rebutted recent allegations that her company’s technology is far less effective than what’s she’s portrayed publicly.
Last week, Theranos came under fire after a scathing Wall Street Journal report called into question some of the company’s practices. The article alleged that Theranos failed to use its proprietary equipment and finger-pricking technology for all, or even most, of the blood tests it offers to patients. Instead, the report said the company used equipment from other manufacturers and required traditional draws of blood from patients, rather than just a few drops. Sources quoted in the article also questioned the consistency and accuracy of tests done using Theranos technology.
But Holmes, speaking on Wednesday at a technology conference hosted by the Wall Street Journal in Laguna Beach, Calif., denied any deception. She repeatedly accused the Wall Street Journal of misinterpreting information it obtained and relying on unreliable sources and misquoting others.
Above all, Holmes countered the claim that the Food and Drug Administration has raised questions about Theranos technology being an unapproved medical device. She said the equipment received approval in July including its “nanotainer,” a tiny vial that holds the few drops of blood drawn using its finger-prick device.
Holmes confirmed that the nanotainer is currently being used for tests for the Herpes HSV-1 test. But she acknowledged that Theranos has “voluntarily” decided against using its own technology for dozens of other tests and is instead using equipment provided by other companies that requires traditional blood draws.
She said that Theranos wanted to get FDA approval before using its own technology for those tests. It is currently in the process of submitting the related documentation.
The Wall Street Journal’s articles over the past week cast an unflattering light on Theranos, a hot startup with a $9 billion valuation. It suggested that the company had misled the public about the readiness of its technology for commercialization.
On Wednesday, Holmes was asked about another issue bought up in the Wall Street Journal report about the FDA making an unannounced visit to Theranos. Instead of being done out of concern about Theranos’ practices, it was merely a friendly visit to conduct an audit, she insisted. Holmes said she didn’t know why the visit was unannounced.
“I read what was in the article. I thought it was false and we disagree with it,” she said.
Holmes also denied the allegations that Theranos cheated on regulatory tests that are designed to ensure that testing is accurate and consistent. According to Holmes, Theranos followed all the procedures, but because no other company uses its technology, it was forced to submit tests using the third-party equipment for certain tests. The emails on the matter obtained by the Journal were taken out of context, Holmes said.
Holmes also sought discredit the sources cited in the reports, stating that some of them “are clearly very confused.”
“I’ve never seen the WSJ as a tabloid magazine. Quoting a widow is an inappropriate area,” she said in reference to comments made by the wife of Dr. Ian Gibbons, a source in the recent article who committed suicide after working for Theranos.
Theranos plans to publish documentation in the coming days to further support its claims, Holmes added.
Following her appearance on-stage, the Journal issued a statement thanking her for her participation at the event, although it said it still stands by its original reporting and disagrees with her claims that it failed to sufficiently seek comment from Theranos.
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(The story has been updated with a statement from the Wall Street Journal about Holmes’s interview on stage.)