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Theranos CEO Devastated Over Lab Problems

With CMS mulling whether to shut her out of the lab testing business, Theranos founder and CEO Elizabeth Holmes appeared on NBC's "Today" show to take responsibility for her company's actions. Troubles, though, could be getting worse for the company, with Bloomberg reporting a potential federal investigation.

Qmed Staff

Elizabeth Holmes Theranos
Elizabeth Holmes

Theranos CEO Elizabeth Holmes was on NBC's "Today" show, saying she was "devastated" that the blood-testing company did not catch problems at its Newark, CA laboratory sooner.

"Anything that happens in this company is my responsibility at the end of the day," Holmes told NBC special anchor Maria Shriver.

The interview came days after the Wall Street Journal broke the news that the federal government has proposed banning Holmes from the blood-testing business for at least two years if the company cannot prove it has fixed serious problems at its California laboratory.

Theranos' problems could be getting even worse: Bloomberg broke the news late Monday that federal prosecutors and the U.S. Securities and Exchange Commission are potentially investigating the company. Bloomberg cited a memo sent to the company's business partners.

In a letter dated March 18 and obtained by the Wall Street Journal, the Center for Medicare and Medicaid Services cited Theranos for continued failure to address issues at the plant following a CMS inspection in November.

CMS had already said in January that, it might fine the firm, or suspend or revoke its certification for testing human samples. The agency is now threatening fines and revocation in addition to shutting Holmes and Theranos president, Sunny Balwani, out of the business.

The Silicon Valley startup, once valued at $9 billion, became well-known for its blood-testing technology, which promised to perform multiple diagnostic tests with a single drop of blood. Following previously released CMS reports stating that the company may be putting patients in danger and that its test results are erratic, the company has been on the defensive publicly.

To help boost its expertise, Theranos has beefed up its scientific and medical advisory board with eight medical and lab testing experts.

Holmes told NBC's Shriver that Theranos responded to inspectors' complaints by stopping testing in California and rebuilding the lab's operations from scratch. The company's Arizona lab, which performs the builk of Theranos' blood testing, has meanwhile passed inspections. 

Will Theranos survive? "Absolutely," Holmes said. "It's a change that needs to happen in the world," she said of the company's goal to provide easily accessible finger-prick blood tests.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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