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HealthTheranos

Theranos Chief Elizabeth Holmes Is ‘Devastated’ Over Lab Deficiencies

By
Sy Mukherjee
Sy Mukherjee
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By
Sy Mukherjee
Sy Mukherjee
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April 18, 2016, 11:21 AM ET

Theranos founder and CEO Elizabeth Holmes says she feels “devastated” over the lab deficiencies which have put her blood testing upstart under siege and led regulators to suggest potentially banning her from the industry for at least two years.

“I feel devastated that we did not catch and fix these issues faster,” Holmes told NBC’s Maria Shriver in an interview aired on the Today show Monday morning.

Theranos has been hit with a series of body blows over the past six months, including allegations that the firm’s “nanoprick” blood testing tech doesn’t work as advertised and that one of its California laboratories employed unqualified staff. The barrage of criticism from the Centers for Medicare & Medicaid Services (CMS), including one notice saying the lab deficiencies posed “immediate jeopardy” to public health, has eclipsed Theranos’ once-rising star and threatens to derail a major distribution deal with Walgreens (WBA).

The company has responded by saying that it’s working hard with regulators to resolve the issues. But in a scathing letter uncovered by the Wall Street Journal last week, CMS mulled harsh sanctions against Holmes and Theranos president Sunny Balwani, including the potential two-year industry ban and revocation of the federal license for its California lab, for not fixing the problems quickly enough.

Holmes told Shriver that the buck ultimately stops with her. “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.”

When pressed on whether or not the various violations and deficiencies that Theranos must address should have been fixed from the get-go, Holmes responded, “Absolutely. Probably the most devastating part of this is that I thought we did.”

Holmes still expressed optimism that her company will bounce back from its current woes. Recently, the firm hired an impressive cadre of medical experts in response to criticisms that its board was stacked with big names and political figures who had little scientific experience.

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