One of Theranos’ top defenses against the Wall Street Journal‘s incisive exposé has been its good standing with the Food and Drug Administration.
Well, looks like that’s crumbling.
The FDA has said that Theranos’ “nanotainers” are actually “uncleared medical devices” that are being wrongfully shipped across state lines. These nanotainers, to be clear, are the tiny vials pictured above that Theranos has built its reputation around. They collect small drops of blood from the finger for analysis, instead of several vials of veinous blood which are used in standard blood testing.
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The FDA’s assessment is based on two inspection reports (here and here). A WSJ report breaks it down:
The FDA inspection, which spanned Aug. 25 to Sept. 16, also found a number of deficiencies in Theranos’s quality-assurance processes, the reports show. Among them, Theranos didn’t investigate whether the suppliers of materials it used had met the company’s quality requirements, according to one of the reports. In addition, Theranos was “unable to produce documented supplier qualifications,” the report said.
Specifically, the FDA says Theranos’ capillary tube nanotainers have been misclassified as Class I devices – the lowest risk form of medical device. However, FDA deems the nanotainers as Class II devices, which are described on its site as such:
Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices.
It says that Theranos is shipping this “uncleared medical device in interstate commerce, between California, Arizona and Pennsylvania.” FDA says Theranos hasn’t responded to complaints to the nanotubes appropriately – such as that they’re “too opaqueto be able to see clotting clearly.”
Last July, Theranos got its first – and only – FDA clearance for a herpes diagnostic test. In its rebuttal to the damning WSJ report, Theranos relied heavily on the validation it received from FDA for its technology.
