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US regulators investigate Theranos complaints: WSJ

Elizabeth Holmes, founder and CEO of Theranos
Mike Blake | Reuters

U.S. health regulators are probing complaints about laboratory and research practices at Theranos by two former employees, The Wall Street Journal [WSJ] reported on Sunday.

According to one complaint filed to the Centers for Medicare and Medicaid Services in September, Theranos management allegedly told lab employees to continue testing patients using blood-analysis devices that had "major stability, precision and accuracy" problems, the WSJ said.

Another complaint sent to the Food and Drug Administration earlier this month showed a 2014 herpes study submitted for FDA approval was actually performed with breaches in research protocol.

The WSJ didn't mention how it obtained copies of both filings.

FDA: Theranos shipped 'uncleared medical device'

Theranos has said it wasn't provided with copies of any alleged complaints, with a spokeswoman telling the WSJ "we have no basis to evaluate what is in it or even if a complaint has been filed."

As a blood-testing startup that claims to have developed hundreds of tests using a finger stick rather than the traditional venipuncture method, Theranos was initially welcomed as a healthcare disruptor.

But an October expose by the WSJ ignited a series of accusations and a Fortune story last week has again raised scrutiny over the company.

Read the full WSJ story here.

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