FDA Rebukes Theranos for Selling 'Uncleared' Device

Alicia Ault

October 27, 2015

In documents just made public, the US Food and Drug Administration (FDA) said that Theranos is selling an "uncleared medical device" as the collection unit for its blood testing, and has also cited the diagnostic company for 13 other potential violations of FDA regulations.

Theranos had previously acknowledged that the inspection took place, but had not made the agency's findings public.

The FDA conducted an inspection at a Theranos facility in Newark, California, from August 25 to September 16, and documented 14 "observations," or problems in two reports (report 1, report 2) posted to the agency's website today.

The Capillary Tube Nanotainer has been sold as a class I exempt medical device, but is in fact a class II device, which means that Theranos is in effect selling an unregulated and unapproved product, according to the agency documents. Class I devices are considered to be low risk by the agency, but class II devices "require greater regulatory controls to provide reasonable assurance of the device's safety and effectiveness," according to the FDA.

Theranos has received much attention from Wall Street and the media. Since its founding about a decade ago, the company has said that its new blood collection and testing method — using just a finger prick, and a few drops of blood deposited into the Nanotainer and analyzed on a proprietary system — could revolutionize diagnostics.

The FDA said, however, that the design for the nanotube "was not validated under actual or simulated use conditions." The agency also cited Theranos for not setting up "adequate procedures for receiving, reviewing and evaluating complaints."

And, said the FDA, "Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary."

Problems "Addressed and Corrected"

The company promised to fix the problems within a week of the final inspection in September, and in a statement told Medscape Medical News, "We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection and have submitted documents to FDA that say so."

Theranos also said that the inspections came in the midst of the company's transition to a different regulatory model. "We are charting new pathways, and are working to create a model for the transition from the [laboratory developed test] framework to the FDA quality systems framework," the company said.

In the meantime, as Theranos had already announced, it has stopped using the Nanotainers for all of its tests except for the herpes simplex virus-1 immunoglobulin G diagnostic, which was approved by the FDA in July. It is instead using venous blood collection tubes until the FDA clears the Nanotainer, said Theranos, in an October 22 posting to its website.

In that same post, the company defended its record — which has been under scrutiny by the Wall Street Journal, among other publications. "We are confident in the reliability of our tests, because we comprehensively validate the accuracy of every test we run," said the company.

The Journal and other news organizations reported on October 23 that Walgreens — one of Theranos' main partners — won't open any new centers until the company answers some of the questions that have been raised about the quality, safety, and effectiveness of its testing systems.

The chain pharmacy has been offering Theranos tests at wellness centers in its Arizona and Palo Alto, California, locations.

Congressional Scrutiny Around the Corner?

Theranos may be the center of attention again in a few weeks when the House Energy and Commerce Subcommittee on Health meets to discuss draft legislation on diagnostic tests.

Lab testing has been a perennial issue of interest to Congress. The House subcommittee will hear from officials from the FDA and the Centers for Medicare and Medicaid Services at a November 17 hearing, seeking feedback on the current regulatory state and what roles the agencies will play going forward, according to a press release.

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