She is awaiting response from CMS. “Anything that happens in this company is my responsibility at the end of the day”.
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The company has also been probed by the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and two state health departments. “We stopped testing and have taken the approach of saying, ‘Let’s rebuild this entire lab from scratch so that we can ensure it never happens again'”.
As we’ve previously shared with you and as could be expected, surrounding critical Wall Street Journal articles a number of regulators began investigations.
Regarding the letters as well as the six months of controversy over the accuracy of Theranos’ tests, Holmes told Shriver that as the founder and CEO, the responsibility for the problems is hers alone.
The company, which has come under scrutiny following reports about irregularities with its tests, is the subject of a criminal probe as well as a civil probe from the SEC, according to a separate report by the Wall Street Journal.
Elizabeth Holmes, founder and CEO of blood testing company Theranos, said she was “devastated” by failures at the company’s California laboratory, which have left federal regulators threatening to shut down the lab and ban Holmes from the business of blood testing for at least two years. Days after the Journal published its initial report about Theranos last fall, Holmes appeared onstage at the newspaper’s tech conference. “I know what we’ve built and I know what we’ve created and I know what it means to people”, she said.
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At the AACC Clinical Lab Expo, more than 750 exhibitors will fill the show floor of Philadelphia’s Pennsylvania Convention Center, with displays of the latest diagnostic technology, including but not limited to mobile health, molecular diagnostics, mass spectrometry, point-of-care, and automation.
