The FDA made a surprise visit to Theranos, says report

The Wall Street Journal reported Friday that blood-test startup Theranos, under scrutiny by the Food and Drug Administration, has stopped using its fingerprick method for all but one of its more than 240 tests.

FDA officials recently appeared at Theranos’ Palo Alto headquarters unannounced, the Journal said, quoting an anonymous source. Federal officials considered the “nanotainers” the firm uses to collect blood from finger pricks an “unapproved medical device,” the article stated.

That report raised more doubts about the diagnostic company’s basic premise that it would offer people routine blood tests from a pinprick.

Earlier this week, the Journal reported a myriad of concerns about Theranos’ technology, as I wrote.

On Thursday, Elizabeth Holmes, the firm’s CEO and founder, appeared on CNBC’s “Mad Money.” She said:

This is what happens when you work to change things, and first they think you’re crazy, then they fight you and then all of a sudden you change the world.

Secrecy has long worked for Theranos, building up intense interest in the firm. Now, on Twitter, Theranos has been on the offensive:

Above: Elizabeth Holmes, chief executive of Theranos. (Karl Mondon/Bay Area News Group)

 

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