U.S. government says Theranos lab poses ‘immediate jeopardy to patient safety’

Theranos, the high-profile Silicon Valley company that promised to revolutionize blood testing was warned by federal regulators this week that its laboratory has “deficient practices” at its Newark, Calif. facility that “pose immediate jeopardy to patient health and safety”, according to a letter sent this week.

Theranos has 10 days from the day it received the letter, January 25, to submit evidence to CMS showing that they have corrected the deficiencies.

If Theranos doesn’t take immediate action, the lab could lose its certification, which which would bar the lab from performing testing. Information about the letter leaked earlier this week.

But in October 2015 the company was rocked by a Wall Street Journal investigation into exactly how much – or how little – it actually used its own technology during tests.

Specifically, the document cites problems with the laboratory director, the technical supervisor, hematology, and the lab’s analytic systems.

Theranos, a closely held company that has been valued in private investments at about $9 billion, has been under fire after reports that the company overstated the ability of its tests to accurately perform several dozen types of measurements.

Theranos has said its technology can run finger-stick samples for tests that have typically required an entire vial of blood.

“As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems”.

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

In response to CMS’s complaints, Theranos said it has made “policy and personnel changes” at its Newark lab, including appointing a new lab director, Dr. Kingshuk Das. It will complete the rest and file a report back to the CMS claiming compliance in a few days, the company said. The company says it is taking additional corrective steps.