FDA Releases Inspection Findings From Theranos Visit

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Pulitzer Prize-winning journalist John Carreyrou has published yet another damning piece about Theranos in the Wall Street Journal, his third in the last two weeks. In his most recent piece, Carreyrou reviews newly released FDA inspection reports from two unannounced visits the agency conducted at the Silicon Valley medical laboratory of Theranos. In its findings, the FDA clearly states that the “nanotainers” Theranos uses to collect and store blood samples are uncleared Class II medical devices, and notes that the company erroneously assumed that they would be considered exempt Class I devices.  The “nanotainers” in question are small vials that Theranos developed as part of the proprietary finger-stick blood test technology. Theranos claims that its proprietary analyzer, called Edison, in combination with the “nanotainers” can process hundreds of different blood tests with just a finger-prick, while its competition’s analyzers require a full venous blood draw. This revolutionary step forward in lab processing power propelled the company to a value of $9 billion.

Last week, Carreyrou published a piece in the WSJ alleging that the FDA had shut down its use of its “nanotainer” and that as a result, Theranos was only using its Edison and “nanotainer” technology to analyze one blood test, the herpes test it received FDA clearance for earlier this year. All of the 240 other tests that it markets have been moved over to traditional lab analyzers. At the time, Theranos maintained a Web page and media talking points that gave the impression that all was well behind the scenes. The day after the WSJ article went live, Theranos responded by calling the story misleading. In its own statement, Theranos acknowledges that it had scaled back its use of the “nanotainer,” but the statement insinuates that it was its own strategic decision to move in this direction: “The FDA is putting our tube that transports the blood for our devices through its rigorous review process. That’s what we are advocating for…. Our decision to engage with FDA at these unprecedented and transparent levels is, in and of itself, innovative.” A later statement from Theranos continues to drive the same point home: “In our discussions with FDA, we determined that it was appropriate to temporarily pause use of the Nanotainer™ tubes for all tests except our cleared HSV-1 test.”

While Theranos does indeed seem to have a new technology that will likely shift a number of tests from venous draw to finger-stick, resulting in faster and cheaper results for doctors and patients, the company is alienating the very doctors and payers that would refer patients when it sidesteps major issues and attempts to camouflage the reality of what is happening back in the Theranos labs. Still, many companies have paused their ramp-up periods because of setbacks with regulators, and Theranos, with its seasoned and influential Board of Directors, should be more than capable of navigating these waters in a way that keeps it in business and eventually allows it to return to market with approved blood tests.


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