US health regulators probe Theranos over inaccurate blood-testing device

The $9 billion startup company, Theranos Inc, is under investigation by the Food and Drug Administration after complaints from former employees regarding the company's inaccurate blood testing device. 

According to a report from The Wall Street Journal, a former employee filed a complaint to the Centers for Medicare and Medicaid Services (CMS) against Theranos' management for allegedly instructing lab employees to continue testing patients with blood analysis devices even when the devices have "major stability, precision and accuracy" problems. Theranos' champion blood-testing device, Edison, allegedly produces "radically different results".

The other complaint was sent to the FDA by another former employee stating the Theranos study submitted last year to win the agency's approval for a herpes test has breached a lot of research protocols.

The International Business Times reports that the company has declined to give any comment regarding the allegations as they have not received any copy of the complaints.

"Agencies have a process for evaluating complaints, and many complaints are not substantiated," said Theranos spokeswoman Brooke Buchanan. The company also has rejected the allegations against their Edison.

Elizabeth Holmes, Theranos Inc.'s Chief Executive, defended her company from published stories suggesting her company was relying on traditional lab tools because it is struggling with its own technology, according to a report from Reuters. Holmes defends her company and said it is transitioning from one of its devices as it waits approval from the FDA for all of its tests.

The company was founded in 2003 by Elizabeth Holmes who was 19-year-old at the time. She captured the whole world's attention when she patented the device which can perform multiple tests with one drop of blood and can transmit the data wireless. With the $9 billion funding for her company last year, Holmes easily became Forbes' youngest and richest female billionaire.  

Tags

Theranos, FDA, Elizabeth Holmes, blood testing device, Edison

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