Theranos Inc Under Investigation for Device Deficiencies, Walgreens Partnership Could be In Jeopardy
Theranos Inc is a Silicon-Valley medical startup known mostly for its development of a simple, practical, painless blood tests that require only a finger price of blood to conduct various tests. They recently partnered with Walgreens Boots Alliance Inc to develop blood-drawing stations at Walgreens “wellness centers” across California and Arizona (for now). So far there are 41 of these outlets between the two Western states.
While the product and the concept have been well-received, though, Theranos labs have been recently scrutinized under threat of inaccurate methodologies which may have led to “serious” and “severe” deficiencies.
According to federal health inspectors with the Centers for Medicare and Medicaid Services—which is the chief federal regulator of all clinical labs in the United States—these problems are far more severe than those which were originally cited by the CMS from the inspection last year.
No details about the discovery have been released yet, but those involved do indicate that Theranos appeared to resolve those previous discrepancies. What is known, at least for now, is that the reports appear to pertain to proprietary vials the company calls “nanotainers,” which the FDA had determined in October to be an “uncleared medical device.”
As such, though, the company has ceased collection of tiny blood samples for all but one of their tests, now waiting for the US Food and Drug Administration to review the report(s) and deliberate on an appropriate course of action. The only test they are now conducting is the one which detects herpes using a proprietary Edison device; the test for which has been approved by the FDA.
In the meantime, Theranos is using traditional analysis machines for the remaining of its more than 200 tests they currently offer to consumers. Furthermore, the company also said it has outsourced some of the remaining tests to other labs which, of course, comes at a loss to them.
Of course, Walgreens has had to also face the consequences of these investigations, debating the benefit of closing any or all of the 41 wellness centers. Regardless of this decision, though, the company may have to reevaluate the future of this partnership.