USA regulators charge Theranos CEO with fraud

SEC accuses Theranos CEO Elizabeth Holmes of ‘massive fraud

Modal Trigger Theranos CEO Elizabeth Holmes REUTERS

Silicon Valley-based blood testing company Theranos and its chief executive officer agreed to settle fraud charges with federal regulators Wednesday. The SEC said Wednesday that it will pursue its case against the president of the company, Ramesh "Sunny" Balwani, in federal court.

Theranos, once the biotech darling of Silicon Valley, fell far after the Wall Street Journal uncovered that the company had doctored research and ignored quality control testing of its purportedly revolutionary blood testing device. In it, Carreyrou reported that the company was likely overstating the abilities of its blood-testing technology - a report that was instantly derided by Holmes and her true believers.

In a statement on its website, Theranos announced the charges and settlement.

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The Silicon Valley-based Theranos was founded in 2003 and claimed its portable blood analyzer could perform comprehensive tests almost anywhere with only a few drops of blood from the finger.

"In truth, according to the SEC's complaint, Theranos' proprietary analyzer could complete only a small number of tests, and the company conducted the vast majority of patient tests on modified and industry-standard commercial analyzers manufactured by others", the SEC wrote. Despite the hype and company claims, Theranos shared few details on how its Edison machine - named after the inventor - worked. Mattis later joined Theranos' board - which he resigned to become Defence Secretary. The group was criticized for lacking expertise in science or medicine.

Holmes went on Jim Cramer's Mad Money show on CNBC and, riffing on a line first uttered by her idol Steve Jobs, voiced righteous indignation: "This is what happens when you work to change things".

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In 2015 Arizona lawmakers voted to make it easier for Theranos to market its testing services directly to Arizona consumers.

After the Journal's investigation, Theranos and Holmes pushed back hard, and for months refused to acknowledge that its machines were effectively a sham. In 2016 the Centers for Medicare and Medicaid Services, which oversees blood testing labs in the USA, banned Holmes from operating a lab and revoked Theranos' blood testing license.

And if the company is sold or liquidated, Holmes would not get a cent until more than $750 million is returned to defrauded investors and other preferred shareholders.

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Theranos and Holmes neither admitted or denied the allegations in the SEC's complaint, and Balwani will face litigation in the Northern District of California from the SEC related to its claims against him. She also will return about 18.9 million shares she obtained during the fraud. "The Company is pleased to be bringing this matter to a close and looks forward to advancing its technology", it said.

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