Observational studies fill void left rcts

The moves are seen as attempts by Theranos to persuade the CMS not to impose stiff sanctions that the agency threatened in the aftermath of its inspection of the company’s Newark, California, laboratory. Company records reviewed during that inspection showed that the laboratory ran approximately 890,000 tests a year. The inspectors found that the Edison machines in the lab often failed to meet the company’s own accuracy requirements.

Theranos also told the CDC that it used the Edison devices for only 12 types of tests out of more than 200 offered to consumers and stopped using the machines altogether in late June 2015. Theranos had touted the devices as revolutionary, leading to a $9 billion valuation of the company in 2014.

In March 2016, the CMS proposed banning Theranos founder Elizabeth Holmes from the blood-testing business for at least two years after concluding that the company failed to fix what regulators called major problems at the California lab. The CMS also threatened to revoke the California lab’s federal license and to impose hefty fines against Theranos.

Last week, Theranos announced the departure of Sunny Balwani, its No. 2 executive, who also was under the threat of a two-year ban from the blood-testing industry.

Source: Wall Street Journal; May 18, 2016.

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