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Theranos Test Results Are Erratic: CMS

The bad news keeps continues to pile up for next-gen blood-testing firm Theranos. According to recently released CMS documents, the company's technology failed 29% of its quality-control checks in October 2014. According to the reports, quality problems were commonplace based on analyses performed in July 2014 and from February 2015 to June 2015.

Qmed Staff

A CMS report found that the company's Edison technology--designed to test small amounts of blood from a fingerprick--failed 87% of quality-control tests when measuring a hormone that affects testosterone levels.  Tests used to measure prostate-specific antigen or PSA, failed the firm's quality-control tests 22% of the time in April and May 2015.

The results for a vitamin D test were also erratic based on comparisons to traditional lab machines. The gap between the Theranos results and that of traditional machines ranged from 21% to 130%, according to a CMS review of nine random samples pulled from an internal Theranos study.

The company released a statement on its website acknowledging that the firm had "made mistakes in the past in the Newark, CA lab," but added that has been working diligently to resolve any problems.

A CMS publicly released in January found that Theranos's practices could "pose immediate jeopardy to patient health and safety."

According to anonymous sources quoted by the Wall Street Journal, CMS has not been content with the firm's plan to address quality problems and was planning on sanctioning the company. CMS said in January that, unless the company addressed the issues to its satisfaction, it could fine the firm, or suspend or revoke its certification for testing human samples.

The recent report from CMS also found that the company had been employing unqualified personnel to run its tests and that the company was often slow to notify patients that test results were inaccurate. According to the Verge, one staff member of the Theranos group had a bachelor's degree in liberal studies. Also, CMS also said that the company had been storing blood samples at the wrong temperatures.

An independent test recently published in the Journal of Clinical Investigation (JCI) also questioned the accuracy of the company's technology.

According to Theranos records, the company had been running roughly 890,000 tests per year.

The company becomes well-known for its fingerprick blood-testing technology, which, according to the Wall Street Journal, is internally known as Edison technology. The Journal also stated that Theranos had asked CMS to redact any reference to Edison technology from its publically released documents and to strike out references to what it perceived as referring to its trade secrets.

The company had developed a reputation for being intensely secretive and has hesitated to release data about its technology to the public.

"This is the first time that we've actually seen data from the Theranos instrument, and it's as bad as one would have worried it would be," Stephen Master, associate professor of pathology at Weill Cornell Medical College in New York was quoted as saying in the Wall Street Journal. "Based on this data, it's hard for me to believe that they went live with this instrument and tested patient specimens on it."

"With this amount of variability, you get to a point where you're essentially guessing" what the test results are, Master also was quoted as saying.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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