The embattled health care startup Theranos, which has been fighting off accusations that the effectiveness of its blood tests were unproven, suffered another setback on Tuesday, Oct. 27, when the Food and Drug Administration (FDA) called its Nanotainers—tiny vials used to collect finger pricks of blood—an “uncleared medical device” in two inspection reports.
Theranos, which was last valued at $9 billion, boasts that its Nanotainers can test for a range of diseases from just a pinprick of blood, a far lesser quantity than conventional tests. But a report by the Wall Street Journal earlier in October cast doubts about its effectiveness, charging that the medical results obtained by Nanotainers didn’t match up with that of other tests.
The widely read report put Theranos on the defensive, and on Oct. 26 the company finally agreed to share its testing data with peer-reviewers, days after Walgreens froze the expansion of blood-testing centers that deployed its Nanotainers. Theranos operates in 45 locations, most of them Walgreens Wellness Centers in Arizona.
“Data is a powerful thing because it speaks for itself,” Theranos CEO Elizabeth Holmes said at the Cleveland Clinic conference, the New York Times reported, but did not specify when the data would be published.
The FDA’s reports don’t concern the effectiveness of Theranos’s proprietary technology, and instead focused on the company’s failure to meet bureaucratic standards such as the documentation of “software validation activities” and “quality audits,” nor do the FDA reports pose a legal threat to Theranos, which had already voluntarily halted the deployment of more than 240 Nanotainer tests while seeking FDA approval.
