Complaints from ex-Theranos employees spur two federal investigations

Ars Technica » Scientific Method 2015-12-22

Theranos, Inc., a beleaguered, multi-billion-dollar startup developing blood testing technology, is now under investigation by two federal agencies, according to a report in the Wall Street Journal.

Complaints from former employees sparked the two investigations, one by the Food and Drug Administration and the other by the Centers for Medicare and Medicaid Services (CMS). According to the WSJ, those complaints laid out concerns about breached research protocols as well as severe accuracy problems with the company’s blood tests.

Theranos gained prominence and drew skepticism earlier this year with claims that it could perform a multitude of medical tests with just a few drops of blood. While previous media reports have also raised questions about the accuracy of the fingerprick-based tests, the new report outlines concerns over the only blood test that has so far received FDA approval, a herpes test.

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