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Issues Uncovered

Inspectors from Centers for Medicare and Medicaid Services have found serious deficiencies at blood-testing company Theranos' California lab, the Wall Street Journal reports.

These inspection results have yet to be publicly released, but the Journal says these issues are different and more substantial than the ones found in 2013. Theranos says it has promptly resolved issues uncovered by previous inspections and that it has not yet seen the report from the regularly scheduled CMS audit.

As the Journal notes, Theranos stopped collecting blood samples in its nanotainers for most tests after the US Food and Drug Administration determined that they were unapproved medical devices. The company has been praised for changing how blood testing takes place by developing tests that only need a finger prick's worth of blood, though the Journal has reported that it often collects traditional blood samples from patients' arms. It is also using its proprietary Edison device only for a herpes detection test, which has been approved by the FDA.

In addition, the Journal says Theranos has been outsourcing a number of its tests to other labs, including ones at the University of California, San Francisco and ARUP. Based on what those labs charge for testing and on what Theranos charges, the paper says the company is sustaining losses on a number of tests.