Theranos lab safety probe
Controversial blood-testing company Theranos repeatedly failed to meet lab standards despite asking for extra time to come into compliance, new documents released by the US federal medical regulator CMS have revealed.
The documents [PDF], released under a freedom of information request, highlight "serious deficiencies" at its main lab that have put patients' health "in immediate jeopardy." The company failed to resolve the issues despite being given two months to work on them.
Theranos and its CEO Elizabeth Holmes have been under increasing pressure since an investigation last year revealed its proprietary technology – which led to a $9bn private valuation of the company – was not reliable and the company was using traditional methods to test blood.
Last week, Theranos informed its partners it was being investigated by both the SEC and the US Attorney's office over claims it misled investors and government officials. And the week prior to that, it was revealed that the Centers for Medicare and Medicaid Services (CMS) was planning to shut down its California testing facility and was considering banning Holmes from running such a facility for two years.
In response to the turmoil, Theranos' legal counsel David Boies has given a number of interviews claiming that Holmes still has the board's support and is "in the process of adding significant talent to the company."
In reality, Holmes holds a controlling stake in the company and any change in board members is likely to reflect a desire for many of them – including former secretaries of state George Shultz and Henry Kissinger – to get off a sinking ship. ®