By Thomas Lee
San Francisco Chronicle.
In early July, Theranos, the Palo Alto blood diagnostic startup founded by superstar entrepreneur Elizabeth Holmes, had some big news to share.
The Food and Drug Administration had granted 510(k) approval to Theranos’ testing system for herpes.
“FDA’s review process for 510(k) notifications is widely recognized as one of the most rigorous regulatory hurdles in the world for evaluation of the performance and accuracy,” the company said. “Today’s announcement demonstrates that Theranos has met that standard and is an important step in Theranos’ mission to … empowering individuals everywhere with information to live healthier lives.”
Given the breathless tone of the statement, you would think that Holmes had just won the Nobel Prize for Medicine. But it turns out 510(k) approvals are pretty standard in the medical device industry. And contrary to what Theranos suggested, 510(k) does not mean the agency has blessed the “performance and accuracy” of the company’s technology. It simply means that Theranos’ tests are pretty similar to a previously FDA-approved device on the market.
“The 510(k) clearance is not a determination that the cleared device is safe or effective,” according to an Institutes of Medicine report, commissioned by the FDA itself.
Founded by Stanford dropout Holmes when she was just 19, Theranos has promised to revolutionize health care by introducing a simple way to test for multiple diseases with one prick of the finger.
Holmes’ audacious vision has helped Theranos earn a $9 billion valuation, a superstar board of directors and glowing media coverage. But recent reports by the Wall Street Journal have cast doubt on whether Theranos’ technology really works.
The FDA sent Theranos several 483s, forms that cite flaws such as selling unapproved devices across state lines and not creating a proper system to handle consumer complaints.