Theranos, the blood-testing startup founded and led by Elizabeth Holmes, has been under fire since a Wall Street Journal story questioned its progress, or lack thereof,  in developing its proprietary technology used to derive test results from just a few drops of blood.

Theranos has never been a company to play by the same rules as everybody else. Yes,  other 19 year-olds have raised  boatloads of venture money, as Holmes has--but not in healthcare. She kept her company, today valued at $10 billion, in stealth mode for an astonishing 10 years. She's been very clear that her goal is not merely to build a better testing company, but to save lives through advances in preventative medicine.

Critically, Theranos asked the Food and Drug Administration (FDA) to be its regulator rather than the less rigorous CLIA (Clinical Laboratory Improvements Amendments) system governing its competitors. Theranos "has taken on some fairly big players in the middle of a nasty battle between the CLIA lab organizations and the medical device industry," says Mark Mansour, a partner with Washington, D.C. law firm Mayer Brown. "Theranos says 'We can't be CLIA and FDA, so we're going to jump the gun and become an FDA-regulated company,'... They're trying to equate themselves with the big boys, and the big boys find that galling."

So maybe it's not surprising that Theranos has had few friends since the Journal story broke. While Theranos has always said it did some tests using full blood draws, and used existing technology for some tests, the Journal story was damning: based on interviews with former employees, it claimed Theranos used its own 'Edison' technology for only 15 of the more than 200 tests offered. The story also alleged that, in some cases, test results were wildly variable and inaccurate, and that Theranos hadn't properly conducted its so-called proficiency testing, a government-mandated quality control process.

Rather than going deep into "no-comment" mode, Theranos responded unusually aggressively. The company labeled the Journal story as "factually and scientifically erroneous, and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents." Even within the story, Theranos' general counsel gave detailed--though not necessarily clarifying--responses when "no comment" would have been the expected. David Boies, the company's famed outside counsel, joined its board a couple weeks after the brouhaha started.

It's gotten worse, in multiple turn-of-the-screw-events, since then: The FDA said Theranos needs to resubmit data for the agency to approve its tests. The FDA also asked Theranos to stop using its tiny vials to collect and transport blood, on the ground that those so-called nanotainers were not approved medical devices.  That means Theranos is using full blood draws, from patients' arms, rather than a few drops of bloods from pricking patients' fingers, for all but the herpes simplex test. Walgreens said it was temporarily holding off on any further expansion of its partnership with the company. By last week, things were verging on the comic: In a superior display of pettiness, a Google Ventures partner explained why the firm didn't invest in Theranos, and Theranos responded with the full-on "he-didn't-reject-us-we-rejected-him."

Theranos seems to be coming to the belated realization that its infamous opacity is has become a liability. On Monday, the company said it would release data proving the accuracy of its tests, although it didn't say how or when. In the midst of all this, Holmes  showed up, defiant and unflappable, to be interviewed at the Wall Street Journal's AllThingsD conference.

Too much faking it, not enough making it?

Fake-it-til-you-make-it is pretty much the entrepreneurs' mantra, and with good reason. It takes a ridiculous amount of confidence to take on Walmart or General Motors or LabCorp, or any other established competitor. But there's a thin line between hubris and fraud. When Zappos first started selling shoes, the company was a lot less than it appeared, too: A customer would place an order, and Zappos founder Tony Hsieh would run out to a shoe store, buy the shoes, and ship them. Uber and AirBnB wouldn't exist if they were strictly law-abiding. By claiming they are merely platforms connecting buyers and sellers of a service, Uber and AirBnB have ignored the regulations relating to their industries, and now are lobbying heavily to get the rules changed. 

The problem, of course, is that healthcare isn't footwear. As a patient, I might not care if Theranos uses its own technology, or someone else's. If the results are accurate and I'm paying less for them, who cares? Only investors do, really, and they're supposed to know what they're getting into.

But I certainly care about the accuracy of those tests, and I personally want to know that the company is abiding by all the FDA regs that apply. Yes, entrepreneurs in healthcare complain ceaselessly that the FDA is a roadblock to innovation, but talk to venture investors who specialize in the field, and you'll hear something very usual: Entrepreneurs need to chill out. The FDA has actually done a good job keeping people safe, they will say, and has also done a decent job of pushing ahead treatments that hold extraordinary promise.

That's why the most serious charge against Theranos is not that it uses other companies' technology, but that it botched the FDA-required proficiency testing. Here again, Theranos seems to have benefitted from a loophole. To decide if a blood test is accurate, proficiency testing requires that it be evaluated against its peers--and Theranos has said its tests, using only tiny amounts of blood, have no peer group.

If Theranos has made as much progress as Holmes claims, it still has the benefit of being a private company, and can get things in order without having to issue quarterly reports. Mansour thinks it's more likely that the company has made very little progress. Only the herpes simplex test has been FDA-approved, he notes, and no one has any idea when or if more approvals might come. Again, Theranos' famed secrecy is not helping, although the company does say it's submitted information on 120 tests for FDA approval. "It's disturbing that they're out there and capitalized at a ridiculous level and no one knows what they do," says Mansour.

Keep in mind that the FDA shut down part of 23andMe for nearly two years. For now, Theranos is in better shape than 23andMe was. That company got a warning letter from the FDA that Mansour characterizes as "strict, nasty, almost abusive... the damage to their name was incredible." Yet 23andMe never lost its fight, and recently announced it would pivot into drug development.

Theranos still has a few things going for it: High-level partnerships, gobs of money, a hugely influential board, and most important, no FDA warning letter has been issued. What's vanishing is consumer confidence, and as I see it, Theranos has only two ways to get it back. First, the company can release convincing and complete data that shows its tests are accurate--that the product works. But given Theranos' obsession for secrecy, and uncertainty around its technology, that may be tougher than it appears. If transparency is not possible, Theranos needs to hunker down, and make massive progress in its technology, until it is.

Published on: Oct 29, 2015