Surprise FDA inspection at one of Silicon Valley’s hottest startups Theranos

Surprise FDA inspection at one of Silicon Valley’s hottest startups Theranos

Theranos is stopping its revolutionary blood work technique after being blindsided by the inspection.

Federal officials showed up unannounced to the facilities of super-hot startup laboratory Theranos, slapping its revolutionary pinprick blood vials as “unapproved medical devices.”

Now, Theranos is halting work on its brand new blood test technique, which involves using tiny vials to collect droplets of blood through a pinprick rather than large vials of blood from a traditional needle in vein procedure, according to a Wall Street Journal report.

Theranos is now drawing blood via traditional procedures much like a traditional lab, a disappointing shift for a company that aimed to turned the medical industry upside down with a new blood testing method that was non-invasive and regard just a tiny bit of blood.

Its new method is a flagship technology in the company, which has become one of the hottest startups in Silicon Valley in the medical field. The company is based in Palo Alto, California, and is worth a princely sum already: about $9 billion, reflecting just how valuable advances in the biomedicine field are.

But FDA officials were not impressed with Theranos’ developments, showing up unexpectedly at their facilities after going through data the company voluntarily provided them in an effort to get the testing method approved.

These “nanotainers” as they are called have now been declared an unapproved medical device by the FDA, so only FDA-cleared assays will feature the nanotainers, and most other testing will involve traditional blood draw methods. That means just one test — an FDA approved test for herpes — will used nanotainers.

The pinprick technology has been called Edison, after the famous inventor, and it has become a key product for Theranos. However, it hasn’t taken off as expect, and this is most definitely not helping the company’s cause.

Theranos has been around for about 12 years now. It specializes mostly in medical tests, particularly blood tests.



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