Blood-testing startup Theranos, under fire after reports that the company overstated the ability of its tests to accurately perform several dozen types of measurements, has flaws in the process it uses to validate its products, U.S. Food and Drug Administration inspectors found.
Heavily redacted inspection reports, posted Tuesday by the FDA, said Theranos’s “design validation did not ensure the device conforms to defined user needs and intended uses.” The name of the device was redacted. In addition, “the design was not validated under actual or simulated use conditions.”
The inspections were conducted Aug. 25 through Sept. 16 at Theranos’s Palo Alto headquarters and its East Bay offices in Newark.
“We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection,” Theranos said in an emailed statement.
Theranos says its technology can run finger-stick samples for tests that have typically required an entire vial of blood. While the company lists about 200 tests on its online menu, the company said this month that it is using its new technology on only one, a herpes test.
Theranos voluntarily reached out to the FDA in 2013 and based on the agency’s guidance decided to begin a transition from a laboratory that isn’t regulated by the FDA to a device manufacturer that meets the agency’s quality standards, according to the company’s statement.
“We are charting new pathways, and are working to create a model for the transition,” Theranos said.
The FDA reports said Theranos’s blood-collection device, which the company describes as a capillary tube nanotainer, is a Class II medical device, which is considered higher-risk than the Class I that Theranos had categorized it as.
“You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona, and Pennsylvania,” the FDA document said.
Theranos said it decided to stop using its nanotainers in all except the herpes test, which the FDA cleared in July. In the meantime, Theranos is using traditional vein draws for everything else.
After limiting the technology’s use, the company has said it will resume using the nanotainers and associated testing technology once the FDA reviews and clears more types of tests offered by Theranos and using its technology. More than 120 of the tests developed for use on Theranos’s devices have been pre- submitted to the FDA to gain the agency’s guidance on product development or application preparation, Theranos said.
The accuracy of Theranos’s technology was questioned in a Wall Street Journal article this month. Theranos has disputed the article’s claims, and the Journal has said it stands behind the story.
FDA also listed inspection observations that many startup testing companies unfamiliar with U.S. regulations get slapped on the hand for, including inadequate procedures for evaluating complaints and documenting corrective actions.
The latest company to receive such a notice was Chicago-based Merge Healthcare, which was purchased by IBM for $1 billion earlier this month. Merge received a warning letter on Sept. 30 for failing to show it had adequately reviewed or evaluated complaints.
