SAN FRANCISCO • US securities regulators on Wednesday charged the chief executive of blood-testing firm Theranos, 34-year-old Elizabeth Holmes, with an "elaborate, years-long fraud".
Holmes and Theranos made a deal to settle the case against them, with the penalty including her surrendering majority voting control of the company, according to a statement by the Securities and Exchange Commission (SEC).
A former president at the one-time soaring Silicon Valley start-up was also charged.
Founded in 2003 by Holmes when she was only 19, the company had been seen as a rising star but came under scrutiny after The Wall Street Journal (WSJ) published articles questioning the reliability of its technology.
Theranos, which had touted a new way of testing that uses far less blood and delivers faster results at much lower cost than traditional methods in American labs, had been under civil and criminal investigation over its claims.
The SEC charged Holmes and former Theranos president Ramesh Balwani with raising more than US$700 million (S$917 million) by exaggerating or lying about the business and its technology.
"As a result of Holmes' alleged fraudulent conduct, she is being stripped of control of the company she founded, is returning millions of shares to Theranos, and is barred from serving as an officer or director of a public company for 10 years," SEC enforcement division co-director Stephanie Avakian said in a statement.
Holmes will also pay a US$500,000 fine as part of the settlement, according to the SEC.
"The company is pleased to be bringing this matter to a close and looks forward to advancing its technology," the Theranos board of directors said in a statement.
Theranos and Holmes cooperated with the SEC investigation, and she will return approximately 18.9 million shares as a result of the settlement, according to the firm.
Enforcement division co-director Steven Peikin said during a conference call that the SEC intended to litigate the case against Balwani, seeking a range of sanctions against him.
Holmes was seen for a time as a rising star in Silicon Valley, appearing at events such as the Women In Technology and Politics dinner hosted by Glamour and Facebook, the Vanity Fair New Establishment Summit and events hosted by the WSJ and TechCrunch.
The SEC is not taking aim at the start-up itself, which last year was near bankruptcy and recently obtained a loan to survive, said Mr Peikin. "(It) was really a two-person operation, with Holmes and Balwani in exclusive control and responsible for the conduct," Mr Peikin said. Punishing the start-up would further harm investors the SEC is aiming to protect, he added.
Holmes and Balwani pitched a tale in investor presentations, product demonstrations and media articles about the firm's key product - a portable blood analyser - which they claimed could revolutionise the industry by inexpensively conducting comprehensive tests from drops of blood from fingers.
Theranos analysed only a small number of blood samples on its own equipment, having testing done on standard industry equipment developed by other firms instead, the complaint contended.
SEC complaints also charged that Theranos, Holmes and Balwani claimed that the start-up's products were deployed by the US Department of Defence on the battlefield in Afghanistan and on medevac helicopters, and that the firm would generate more than US$100 million in revenue in 2014. Theranos technology was never deployed by the US Department of Defence and generated a little more than US$100,000 in revenue from operations in 2014, according to the SEC.
A settlement with the SEC does not preclude criminal charges from being pursued by US prosecutors, but Mr Peikin declined to comment on whether any other agencies were investigating the case.