Elizabeth Holmes, founder and CEO of blood-testing company Theranos, said she was "devastated" after an inspection found "critical violations" at her California lab, raising questions about an accuracy of the tests.
The Silicon Valley company, valued at $9 billion, partners with Walgreens to provide quick, in-store blood tests at a fraction of regular prices. In November, a federal inspection by the Centers for Medicare and Medicaid Services (CMS) found the company failed to hire and train qualified staff to work the testing machines, and let unlicensed workers review test results.
"I feel devastated that we did not catch and fix these issues faster," Holmes said in an interview on NBC's "Today" show Monday.
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Holmes said the lab stopped testing and that she is rebuilding the "entire laboratory from scratch," but a letter from regulators in March called her fixes insufficient and threatened to shut down the lab and ban Holmes from the business of blood testing for at least two years.
Holmes said she has hired a new lab director and an expert medical board to prevent any future violations. She is awaiting response from CMS.