US regulators investigate Theranos complaints: WSJ
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.
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.
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