Theranos

Theranos Founder Says the Company Will 'Absolutely' Get FDA Approval

Theranos Founder Says the Company Will 'Absolutely' Get FDA Approval

Theranos' CEO Elizabeth Holmes

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Theranos founder and CEO Elizabeth Holmes is not hiding.

As criticisms of her blood technology company continue to mount, Holmes took the stage at the Fortune Global Forum on Monday and defended her company.

Pushed by Fortune Editor Alan Murray to admit mistakes, Holmes would say only that Theranos needs to “do a better job of communicating” the science and the data behind its offerings. “We haven’t put into the public domain much of our work,” she said. “We haven’t talked about our devices.”

Holmes did confirm that the company, only “as of a few weeks ago,” is using only one “finger prick” blood test commercially, but says that was her own decision, based on her desire to get FDA approval for its process. ” Right now, just because of this FDA transition,” she said, “we are only doing one, but that doesn’t mean we don’t have the technology to do them. There’s no reason we can’t do peer review and publish other statistics.”

Will the FDA approve Theranos’ process? “Absolutely,” she said, seemingly unshaken by the events of the past few weeks.

When asked about Walgreens -- Theranos’ biggest customer -- deciding to hold off on further expansion, Holmes revealed that no one from the company had reached out to her to say so. “They haven’t said that to us,” she insisted.

Holmes also calmly waved off suggestions that the company, valued at $9 billion in its latest round of financing, might be worth less as a result of the controversy. “That’s for the investors to decide,” she said. “But we are definitely not in a position where we need to raise financing at this time.”


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