Following an unannounced inspection by the US Food and Drug Administration, lab-testing company Theranos is only using its tiny blood collection vials for one of its tests, the Wall Street Journal reports.
The company, which is valued at $9 billion, has been praised for "revolutionizing" testing with its development of an approach that only requires a finger pricks' worth of blood from patients. But now, the Journal notes, it "is operating more like a traditional lab that draws blood with needles from patients' arms. "
The FDA deemed the company's 'nanotainers' to be an unapproved medical device, a WSJ source says. The source also tells the Journal that the inspection was due to concerns regarding data the company submitted to FDA as it sought approval for its proprietary testing methods.
Theranos founder Elizabeth Holmes told CNBC that the company is only uses its nanotainers for FDA-cleared tests, and the Journal notes that the agency cleared one of its tests, for herpes, in July.
It adds that the company has since also been audited by the Centers for Medicare and Medicaid Services.
The Wall Street Journal reported yesterday that Theranos has been struggling with its Einstein instrument and was relying on machines from other companies to run many of the tests it offers. It also said there were questions surrounding some lab and proficiency testing practices there.
In a statement yesterday, Theranos said the Journal's Thursday report was "factually and scientifically erroneous" and that "Theranos' products and services have proven accurate and reliable for tens of thousands of satisfied customers."