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Checking It Out

Regulators in the US are looking into complaints made regarding issues with laboratory practices at blood testing startup Theranos, the Wall Street Journal reports. The Journal reported in October that the company was using its Edison technology for only a handful of tests it runs and noted alleged irregularities in its lab and proficiency testing practices.

In one complaint made to the Centers for Medicare and Medicaid Services in September, a former Theranos lab employee alleged that even though there were "major stability, precision and accuracy" problems with the company's Edison machines, employees were told to keep using them, the Journal reports.

Daniel Young, a vice president Theranos and director of its Arizona lab, tells the Journal that he is "not aware of any pressure from upper management to release errors or unreliable results."

According to the Journal, CMS auditors are inspecting the company's Newark, Calif., lab as part of a regularly scheduled audit.

In the other complaint, made to the Food and Drug Administration this month, a different ex-employee alleged that the study Theranos submitted last year to the agency seeking approval for its herpes test was plagued by research protocol breaches, such as modifying parts of the device partway through the study to improve accuracy. The complaint also alleged that the company underreported how often its machines broke down.

The WSJ says FDA has interviewed the person who made the complaint.

Theranos denied the allegations, and said its study followed established protocols and that what it submitted to FDA was complete and truthful, the WSJ reports. 

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