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FDA Reports Cite Problems at Biotech Company Theranos

Palo Alto-based Theranos has come under heavy fire in recent weeks, as questions continue to surface about their supposed revolution in blood testing procedures.

On October 15th, the Wall Street Journal published a biting expose regarding Theranos’ methods and business practices. Now, the FDA is looking a bit closer as well.

The Food and Drug Administration released two reports in which they state that Theranos used an unapproved medical device. They have also concluded that customer complaints regarding the tests were not adequately addressed. For that matter, quality control procedures themselves were notably deficient.

Theranos has already been facing questions of a far more essential nature; is it even using its technology for the hundreds of tests being offered? The company claims to have the ability to test for everything from dangerous levels of cholesterol to some forms of cancer.

In response, Theranos has offered to publish proof of their accuracy and reliability. Whether that data will be enough for dissatisfied consumers and the FDA itself remains to be seen.

Follow Nate Church on Twitter @Get2Church.

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