Theranos’ Holmes indicted by feds over blood-test ‘fraud’

Elizabeth Holmes in more disruptive times back in 2015

Elizabeth Holmes in more disruptive times back

Elizabeth Holmes, who founded blood-testing company Theranos Inc. only to watch it unravel amid revelations that her main product was a fraud , has stepped down as chief executive officer.

Prosecutors charge that Holmes and Balwani deliberately misled investors, policy makers and the public by falsely claiming that they had developed revolutionary technology that could quickly and cheaply provide a range of clinical tests from a small drop of blood.

Demonstrations of the technology given to potential investors were allegedly "intended to cause potential investors to believe blood tests were being conducted on Theranos's proprietary analyzer when, in fact, the analyzer really was running a "null protocol" and was not testing the potential investor's blood", the US Attorney's office said.

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The indictment says the fraud caused hundreds of patients or their insurers to pay for blood tests and test results, sometimes following referrals from their defrauded doctors. The company and Theranos settled with the SEC, and as part of the settlement, Holmes paid a fine and can not be a director or officer of a publicly traded company for 10 years.

"This indictment alleges a corporate conspiracy to defraud financial investors", FBI Special Agent in Charge John Bennett said in a statement.

The SEC had alleged that Theranos has raised more than $700 million from investors between late 2013 and 2015, while at the same time "deceiving investors" by overselling the ability of the company's diagnostic devices. But the company remained feisty as recently as three weeks ago, when it issued a rebuttal to a "60 Minutes" story timed to coincide with the release of Carreyrou's book, which depicted rampant unethical behavior by Holmes and Balwani. Holmes was stripped of her control of the company as part of a settlement with the SEC. Jeffrey Coopersmith, an attorney for Balwani, said his client did not defraud investors or consumers. "Mr. Balwani is innocent, and looks forward to clearing his name at trial", the statement said.

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Theranos was a private health care and life sciences company with the stated mission to revolutionize medical laboratory testing through allegedly innovative methods for drawing blood, testing blood and interpreting the resulting patient data.

Much of the allegations in the indictment have been previously reported by The Wall Street Journal.

Holmes and Balwani signed up both Safeway and Walgreens into agreements to use Theranos testing equipment inside clinics within their stores. A lawyer for Holmes didn't respond to a request for comment.

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