• CEO Elizabeth Holmes confirms FDA made unannounced inspection
  • Holmes defends her $10 billion startup's laboratory work

Theranos Inc. Chief Executive Officer Elizabeth Holmes stepped into the lions’ den on Wednesday, speaking at an investor conference to defend her blood-testing startup against accusations that it misrepresented its laboratory procedures and relied on third-party equipment to perform most of its blood tests.

Holmes confirmed that the U.S. Food and Drug Administration had conducted an unannounced inspection of Theranos’s labs in July. She also pointed to the company’s work with the agency to get approval for a wider range of tests using its proprietary technology, which it says can perform accurate tests with only a few drops of blood.

“We got our systems cleared by FDA at the end of July. At the end of August, FDA did an inspection at Theranos,” Holmes said. “The inspection was about our compliance with quality systems regulations.”

Holmes, 31, reiterated that the company is using its proprietary finger stick only to test for herpes, the one procedure using Theranos’s Nanotainer technology that the FDA has approved.

The Palo Alto, California-based company, which Holmes has said is valued at about $10 billion, has faced intense public scrutiny following a pair of articles published last week by the Wall Street Journal. Holmes repeatedly criticized the coverage, calling it inaccurate in her appearance onstage Wednesday at the same newspaper’s technology conference in Laguna Beach, California.

“The job of a reporter is to tell truth to the readers,” she said. “Immediately everyone picks it up and reprints it as if its true.”

Anonymous Sources

Holmes attacked the Journal’s anonymous sources, compared the newspaper to a tabloid for quoting the widow of a Theranos founder, and defended her company’s practices across the board. The Journal says it stands by its coverage.

Holmes also challenged a Business Insider article that quoted Google Ventures partner Bill Maris saying his firm had long been skeptical of Theranos’s technology. Holmes said she had never met with Maris and Theranos had waved off investing interest from Google Ventures. A spokeswoman for Google Ventures didn’t respond to a request for comment about Holmes’s remarks.

In response to a question about why Theranos doesn’t submit its research in peer-reviewed research papers, Holmes said she didn’t oppose scholarly review. Instead, she said, the company’s employees were simply too busy.

“If anyone is doing anything, they’re doing FDA submissions, and that’s our full-time job right now,” she said.

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