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| Theranos' Palo Alto, CA, headquarters--Courtesy of Theranos |
Things haven't been going well lately for Theranos, and the storm isn't showing any signs of dying down. A couple of months after The Wall Street Journal published articles that called the company's proprietary technology into question, U.S. regulators are looking into complaints about Theranos' lab testing and research practices from two former company employees.
A former Theranos lab worker filed a complaint in September with the Centers for Medicare and Medicaid Services (CMS) saying that top brass told lab employees to keep testing patients with the company's blood-analysis devices despite signs of "major stability, precision and accuracy" issues with the products. And another ex-employee earlier this month sent a complaint to the FDA, alleging that a study that Theranos submitted last year to win approval for its herpes test violated research protocol, the WSJ reports.
The former lab employee who submitted a complaint to the CMS said that Theranos managers knew that there were problems with its Edison machines, which process samples, but told employees to continue running the samples through the devices anyway. The machines sometimes would yield "radically different results," the employee said in the complaint, as seen by the WSJ, showing varying levels of a thyroid-stimulating hormone, for example.
And quality-control checks of Theranos' general chemistry tests often failed, the former employee said, especially for tests that measure levels of carbon dioxide, calcium, sodium or potassium in the blood. General chemistry tests dilute tiny samples of blood collected on patients' fingers and run the samples on traditional lab machines, and some outside lab experts say that diluting the samples increases the risk of errors, the WSJ reports.
Another employee who sent a complaint to the FDA alleged that Theranos hadn't finished assembling its proprietary testing machines for a study of its herpes test, which was approved by the FDA last July. The company also changed some important parts of the devices to improve their accuracy after the study started, according to the WSJ story, a move that can alter the integrity of the resulting data.
Theranos is staying mum on the complaints, saying that it hasn't received "a copy of any alleged complaint, so we have no basis to evaluate what is in it or even if a complaint has been filed," company spokeswoman Brooke Buchanan told the newspaper. And the former employee who filed the FDA complaint is "uninformed" and disgruntled," she added.
"Agencies have a process for evaluating complaints, and many complaints are not substantiated. We trust our regulators to properly investigate any complaints, and we look forward to continuing our strong and productive relationships with them," Buchanan said.
But the news is unlikely to appease the Palo Alto, CA-based company's naysayers and partners, who are pushing back at Theranos after two WSJ articles in October challenged the company's testing methods. Theranos stopped collecting finger-prick blood samples for all but one of its more than 200 tests after the FDA paid the company a surprise visit over the summer and found that "nanotainers" manufactured and used by Theranos to collect samples were unapproved medical devices.
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| Theranos CEO Elizabeth Holmes |
Now, Theranos is waiting for the FDA to grant it approval for all of its testing tools, although the company can still rely on some of its technology in the meantime, CEO Elizabeth Holmes told The New York Times. Theranos, which is valued at $9 billion, is also trying to trot out data that demonstrates its tests' efficacy, but there's no word yet about when that information will be published.
- read the WSJ story (sub. req.)
- here's the NYT article (sub. req.)
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