view counter

Public healthTheranos blood-testing lab poses “immediate jeopardy” to the public: U.S. government

Published 28 January 2016

Theranos is facing another major setback after the Centers for Medicare and Medicaid Services (CMS) described the company’s blood-testing technology as posing “immediate jeopardy” to the public. The Silicon Valley firm has been valued at $10 billion, raising $400 million from investors for what it described as “breakthrough” technology which allowed it to do blood tests using a pinprick, rather than a full blood draw.

The promise of a blood test with a single finger stick // Source: theranos.com

Theranos is facing another major setback after the Centers for Medicare and Medicaid Services (CMS) described the company’s blood-testing technology as posing “immediate jeopardy” to the public.

Bloomberg reports that the Silicon Valley firm has been valued at $10 billion, raising $400 million from investors for what it described as “breakthrough” technology which allowed it to do blood tests using a pinprick, rather than a full blood draw.

In October, however, a Wall Street Journal investigation raised questions about exactly how much, or how little, the company used its own technology in tests.

Bloomberg notes that the CMS’s letter said that Theranos met the conditions of “a situation in which immediate corrective action is necessary because the laboratory’s non-compliance with one or more … requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.”

CMS also identified five specific areas in which a New Jersey lab operated by Theranos did not meet its standards, but said that “in addition, other standards were also found to be not met.”

Theranos was founded in 2003 by 31-year-old Elizabeth Holmes, the year she dropped out of a course in chemical engineering at Stanford University. The company quickly gained a lot of attention and investment — $400 million at a valuation of $10 billion, according to Bloomberg News, and a deal with insurer BlueCross.