Surprise FDA inspection blocks critical blood work at this red-hot Silicon Valley lab

A surprise investigation by authorities at the Food and Drug Administration showed up at the facilities of laboratory firm Theranos Inc. after concerns were raised about how they did blood work — and it could have big ramifications for the industry.

The FDA declared their new method of collecting tiny vials of blood via a pin prick rather than a traditional needle to be an “unapproved medical device,” and now Theranos is backing down from using the revolutionary technique that has helped make it the $9 billion company it is today, and one of the hottest names in biomedicine, according to a Wall Street Journal report.

Theranos quickly made a name for itself in the 12 years of its existence by pioneering new ways of conducting medical testing. This method of using a mere pinprick to collect tiny amount of blood in tiny vials instead of large amounts through a needle was supposed to revolutionize blood work, but this investigation is the latest setback to that effort.

Now, Theranos is back to doing blood work the old fashioned way in the meantime.

The FDA decided to make the visit after going over data submitted voluntarily by Theranos in an attempt to get the testing method approved, ultimately declared it to be an unapproved medical device. As a result, these “nanotainers” will only be used for one test — an approved test for herpes — and will not be used in the many others that Theranos does.

But the company is not giving up. For now, it’ll be a full-court press to get the nanotainers approved for use by the FDA, so they will begin jumping those hurdles right away.

Still, it’s been a rocky road for Edison, the name for the product, named after the inventor. It hasn’t quite on nearly as quickly as had been thought, and this latest wrinkle from the FDA will certainly not help matters.