FDA inspectors have declared that the vials Theranos uses to collect blood samples are uncleared medical devices. What s more, the company didn t seem to be delivering on what it claimed to do, according to the inspectors. Although these are observations and not an official agency decision, this is just the latest headache for the Silicon Valley company.
Theranos, a privately held tech darling with a $9 billion valuation, has been in the spotlight since a mid-October Wall Street Journal article raised questions about its technology. The article said the company only used its much-touted Edison finger-prick technology for a few tests and relied on other methods for a majority of the 240 tests it offers, and also raised doubts about test accuracy.
Founder and CEO Elizabeth Holmes and the company have tried to fight back. And Monday, Holmes reportedly said the company would begin publishing data to prove the accuracy and validity of its test results.
The FDA observations, which resulted from inspections from Aug. 25 to Sept. 16, said a nanotainer tube used by Theranos for blood collection are not listed correctly and therefore aren t cleared: You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania.
In a statement emailed to SiliconBeat, Theranos said:
We worked closely with FDA representatives and provided all requested information. At the conclusion of the inspection, FDA issued two Form 483s outlining observations made during the inspection. None of these observations pertain to Theranos analytical devices or chemistries, or the manufacturing infrastructure for either. The observations were specific to only one of Theranos nanotainer tubes. All observations were specific to the nanotainers operating under the CLIA lab quality framework. The correction to the observations was to cut over to the FDA Quality Systems framework.
Theranos said it is already transitioning from the CLIA (Clinical Laboratory Improvement Amendments) framework to the FDA framework.
In addition, a couple of key FDA observations show the company did not seem to have enough proof of its claims about its technology: Design validation did not ensure the device conforms to defined user needs and intended uses, and the design was not validated under actual or simulated use conditions.
The inspectors also deemed inadequate the company s compliance with listing, documentation, quality assurance, audit requirements and more.
The company says it is in close contact with the FDA. More from the Theranos statement:
Over 120 of the tests developed for use on our devices used as part of Theranos proprietary technologies have been submitted in pre-submissions to FDA. This voluntary engagement with FDA is not only a statement about our confidence in our technologies, but this summer s clearance and CLIA waiver would not be possible if our devices and technologies did not work with those tests. Theranos technologies includes its devices, chemistries, consumables, and software, in addition to its Nanotainer tubes. These proprietary systems and technologies – which we protect as intellectual property – have been rigorously tested and reviewed, and continue to be.
Walgreens, which has a partnership with Theranos, said last week that it would hold off on the planned expansion of blood-testing centers at its stores.
The FDA observations are here and here.
Photo: Elizabeth Holmes in 2014. (Karl Mondon/Bay Area News Group)
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