Theranos’ Only FDA Approved Test Is Also Under Scrutiny After Ex-Employee Complaint

Two former Theranos employees have filed complaints so far with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) over alleged faulty test results. The latest complaint is aimed at a test for herpes – and it is the only test the FDA has so far approved blood diagnostics startup Theranos to run using its proprietary technology.

One former employee filed a complaint in September to CMS alleging upper management had instructed lab employees to continue using Theranos’ proprietary blood testing technology, even though there were indications of “major stability, precision and accuracy” with those tests, according to a recent Wall Street Journal article.

That complaint may have tipped off the FDA. The administration shut down Theranos’ use of one of its “nanotainers” or tiny vials of blood purported to deliver accurate test results on a number of conditions with just one drop of blood that same month. The FDA declared these “nanotainers” to be uncleared medical devices after an inspection of Theranos’ California facilities.

Theranos then went into a self-imposed quiet period in October while it waited for FDA approval of its technology to use on other tests.

However, one test out of the 15 Theranos was reportedly running on its proprietary machine went unscathed. The U.S. health administration gave the clearance for Theranos to run a test for herpes on that machine in July – and was the only test the FDA approved Theranos to run.

But things might be going from bad to worse for the company valued at $9 billion on paper. Another former employee has now filed a complaint with the FDA this month alleging the study submitted by Theranos for its herpes test was “tainted by breaches in research protocol,” according to the Journal.

What does this mean for Theranos? According to the Journal article, the company hasn’t seen the allegations and believes this former employee could be “disgruntled.” Though this isn’t the first time Theranos’ technology has been called into question and certainly not the first we’ve heard from others concerned about Theranos’ testing practices.

Walgreens, Theranos’ third-party testing partner, has halted expansion of services while an investigative team looks into the allegations and Safeway grocery stores pulled out of a deal that would allow customers to order Theranos tests through Safeway pharmacies after executives grew concerned over accuracy of those tests – Though Theranos told TechCrunch it would be announcing new distribution partnerships in the coming year.

Theranos said it did not have to seek FDA approval for diagnostic tests and that it is one of the only labs to do so. “We’re doing this voluntarily,” Theranos’ spokesperson Brooke Buchanan said. Theranos also disputes the complaints about upper management instructing lab employees to continue administering possibly faulty tests.

Buchanan tells us the Journal has not shared the two complaint letters with them and that it is hard to tell the nature of the complaint or who it is coming from without that knowledge. “Just because a complaint has been filed doesn’t mean it’s substantiated,” Buchanan told TechCrunch.

*This story has been updated with commentary from Theranos.