Regulators find big deficiencies at Theranos lab

Citing people familiar with the matter, The Journal reports that the problems observed by CMS health inspectors were more serious than the agency's inspection in 2013.

Another road block for the Silicon Valley company that said it would revolutionize the blood-testing business.

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. In October, FDA said it had determined that the nanotainers were an "uncleared medical device".

In the meantime, Theranos is using traditional analysis machines for the remaining of its more than 200 tests they now offer to consumers. The only test for which the Edison device is still approved by the FDA is to detect herpes. Those deficiencies, Theranos says, were promptly resolved. The inspection results are expected to be publicly released soon, according to WSJ's sources. A Theranos spokesperson told the Journal that the company doesn't yet have the CMS report but noted that Theranos "has continued its ongoing work to build best-in-class systems and engage in partnership with its regulators". Recent customer volume and referrals from medical providers have been "record-breaking", she said.

Walgreens has reportedly suspended plans to expand the program for now.

It isn't clear exactly what regulators have faulted Theranos for in their latest inspection, which took several months.

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