FDA Draws Blood in Reports on Revolutionary Biotech Firm

Startup Theranos used unapproved device, didn't field complaints: FDA
By Jenn Gidman,  Newser Staff
Posted Oct 28, 2015 2:33 PM CDT
FDA Draws Blood in Reports on Revolutionary Biotech Firm
Theranos has some issues to resolve.   (Shutterstock)

One year ago, Elizabeth Holmes was the golden child of the biotech world: The college dropout's company, Theranos, had developed a seemingly revolutionary way to draw blood (just one finger prick), and Holmes was named the youngest female billionaire in the US at age 30. News out of the FDA Tuesday, however, wasn't quite as encouraging, with the agency releasing two reports based on its inspections of Theranos facilities, the New York Times reports. Among key issues are allegations the $9 billion-plus firm shipped an unapproved blood-collection tube over state lines and that there were multiple QC issues. USA Today notes the company is also accused of not sufficiently addressing complaints the small containers might obscure blood clotting. The FDA's findings were the result of surprise visits in August and September to Theranos operations under the agency's authority to regulate medical devices, a source familiar with the situation tells the Wall Street Journal.

The reports, which the Times concedes are "heavily redacted" and "difficult to interpret," outline more than a dozen "observations" about flaws in QA processes and accompanying paperwork. The reports also said necessary audits weren't performed and proof wasn't readily available that parts suppliers were up to par. Theranos "addressed and corrected" all the FDA's issues "at the time of, or within a week of, the inspection" and provided proof to the agency, a Theranos spokeswoman said in a statement Tuesday, via the Journal. Still, Theranos says it's cooperating with efforts to remedy any remaining issues, though it's been somewhat on the defensive after earlier reports about its struggles. The company says it's stopped using its nanotainer for all but one test until its gets the FDA green light (though the Times notes that was only after "explicit pressure" from the FDA), and Holmes said at a conference this week she'd make her company's data public so it could be validated. (More FDA stories.)

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