Theranos is a very high-profile startup doing blood tests. You’ve probably come across them (or their founder, Elizabeth Holmes), promoting “X number of tests from a single drop of blood” and so on. The company has been making a big splash since at least 2013, when this article in the Wall Street Journal came out (I keep thinking that I’ve written about them here, but I can’t find a post, so apparently not). In that article, things are working fine:
Theranos’s technology eliminates multiple lab trips because it can “run any combination of tests, including sets of follow-on tests,” at once, very quickly, all from a single microsample. Ms. Holmes estimates that patients and doctors will receive readouts in “as little as two hours” and can even do so before an office visit based on their physician’s recommendation for better, or at least less ad hoc, consultations. . .
. . .Another Theranos advance is its testing’s accuracy. Ms. Holmes believes the chain of conventional laboratory custody introduces too many opportunities for error, “which is basically wherever humans are involved.” . . .Theranos’s technology is automated, standardized, and attempts to subtract human error from the process. It can thus achieve much lower variance ranges for a given test. Ms. Holmes says its tests have margins of “allowable error” targets less than 10%.
How they’re getting this to work has always been a bit of a mystery, though. And a much different article in this morning’s WSJ by John Carreyrou suggests that they may not be getting to work very much at all. (If that link doesn’t work for you, try going through Google News, which often does the one-time-access trick). It’s a grenade, all right:
But Theranos has struggled behind the scenes to turn the excitement over its technology into reality. At the end of 2014, the lab instrument developed as the linchpin of its strategy handled just a small fraction of the tests then sold to consumers, according to four former employees.
One former senior employee says Theranos was routinely using the device, named Edison after the prolific inventor, for only 15 tests in December 2014. Some employees were leery about the machine’s accuracy, according to the former employees and emails reviewed by The Wall Street Journal.
In a complaint to regulators, one Theranos employee accused the company of failing to report test results that raised questions about the precision of the Edison system. Such a failure could be a violation of federal rules for laboratories, the former employee said.
It goes on, in great details, with many insights from former employees and regulatory filings, and the picture does not look very good at all. Particularly concerning are the proficiency tests, required by Medicare and Medicaid for testing services to show that they’re producing data that are close to their peers. There are detailed allegations that Theranos tried these with both their own system and with current commercial testing systems, with widely varying results, and that the company tried to gloss over these discrepancies. And there are other allegations that the company, since it collects such a small amount of blood, has to dilute these samples to what could be problematic levels to run the other standard blood assays on them, and these could (according to some in the article) be as much as 90% of all the tests in their portfolio.
This has been a key part of the Silicon-Vally-Meets-Medicine story, and a lot of people are going to be very upset if it falls apart. Theranos, or at least their press coverage, has been as much a cult of personality, though, as a biomedical or analytical chemistry story. But analytical chemistry – which is what all this comes down to – is not something that responds very well to well-crafted TED talks, high-profile magazine pieces, and photo shoots. The company has reached the point where they need to demonstrate, in great detail and at excruciating length, that their technology works the way that they say it does.
Update: Matthew Herper has more, including some accusations by Theranos about the story, and some rather defensive conspiracy-mongering by Holmes herself.
Update 2: The WSJ is now reporting that Theranos, at the request of the FDA, has stopped using its nano-scale testing in all but one of its offered assays. This took place fairly recently, after agency inspections, but the company has never disclosed any of the details (or that any such changes took place). Their web site was reworded sometime during the last two months, however. . .