Things just got a lot worse for medical tech firm Theranos, and that’s saying something.
The Silicon Valley startup that aims to change the way we test blood has already been reeling from a series of charges, first leveled in The Wall Street Journal, that it’s nowhere near delivering results it once promised. Now, Theranos finds itself in the crosshairs of the US Government.
The Centers for Medicare and Medicaid Services says the lab run by Theranos in Newark poses “immediate danger to patient safety.”
Theranos' founder, Elizabeth Holmes, was called the world's youngest self-made billionaire as her much-trumpeted company gained financing and press. Its board of directors includes Henry Kissinger, George P. Schultz and several other former Cabinet and high-profile government officials.
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The company has reportedly been valued as high as $9 billion.
The Centers for Medicare and Medicaid Services says the lab falls short of several non-specified standards. It isn't clear where the company is coming up short, but the government agency has given Theranos 10 days to provide “acceptable correction.”
Theranos faces fines as high as $10,000 a day, and possible decertification. If that happens, the company can no longer perform tests there.
Theranos released a statement through email, saying the charge leveled “does not reflect the current state of the lab.” It also says the company has made “policy and personnel changes” at the lab.
Scott tracks biotech on Twitter: @scottbudman