Elizabeth Holmes, the founder and CEO of blood testing company Theranos, says she is "devastated" by her company's failures, with its California laboratory in danger of being shut down due to health hazards. To make matters worse, federal regulators are threatening to ban Holmes from the business of blood testing for two years or more.
Although Holmes takes full responsibility for all of the problems at the laboratory, which include inaccurate test results and unqualified workers, she says she was unaware of their existence.
"I'm the founder and CEO of this company," she said. "Anything that happens in this company is my responsibility at the end of the day."
However, when questioned regarding the company's lack of protocols to ensure the laboratory's internal and external quality and proper hiring process, Holmes said that she we unaware of these failures.
"Probably the most devastating part of this is that I thought we did," she said.
Holmes built up Theranos to a $9 million valuation, saying that it would revolutionize diagnostics and patient cure through a new device with the ability to perform numerous medical tests using just a few drops of blood.
Despite these promises, the company has failed to publish or release any sort of data to back up these claims. Furthermore, inspections by the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) found problems in the company's labs that posed immediate dangers to patient health.
Holmes and her staff are now hard at work to resolve the reported problems with their company and have hired numerous experts in the medical community to aid them, although the CMS is still threatening action against them for not responding to the dangerous problems quick enough.
Theranos is now awaiting the CMS's decision in regards to sanctions that could lead to the shutdown of its California lab and prevent Holmes and company president Sunny Balwani from working in the blood testing business for two years or more.
"I know what we've built and I know what we've created and I know what it means to people," she said. "And it is a change that needs to happen in the world."
