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Theranos Faces Even More Damning Lab Test Accusations

Theranos apparently knew that the accuracy of its blood testing technology was questionable and decided to use it for an important hematology test on 81 patients for six months.

Brian Buntz

The bad news keeps piling up for Theranos, the beleaguered blood testing company that had been one of the hottest healthcare startups in Silicon Valley.

In its latest article related to the company, the Wall Street Journal reports that the company knew that its hematology test was inaccurate yet decided to use it anyway to for a test that helps determine how quickly blood clots. The prothombin test is therefore used to treat people with blood disorders and people at risk of strokes. The allegations are contained in a forthcoming CMS report, reports the Wall Street Journal, quoting anonymous people familiar with the CMS document.

Inaccuracy in the test results can cause serious injury to some patients such as those taking blood thinners like warfarin (Coumadin). Overdoses of warfarin can cause severe injury or death, although cardiologists are typically conservative when adjusting warfarin prescriptions.  

The Journal states that the forthcoming report CMS provides more details into the nature of the "deficient practices" outlined in a prior CMS document that the result of a visit by government officials to the company's facility in Newark, CA.

One of the most serious allegations in the WSJ article is that Theranos allegedly ignored red flags related to the quality of its tests and that the results did not always meet its own criteria for accuracy. In fact, results repeatedly deviated by expected quality levels by more than two standard deviations in quality-control protocols performed from April 1 to September 23 of last year.

The director of Theranos's facility, Kingshuk Das, the company's new lab director says that the company has "no reason to believe" that patients have been harmed from problems observed by CMS.  "At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab," he was quoted as saying by the WSJ.

The Journal also quotes a states that Theranos had seven quality-control failures in a single day, according to a person familiar with the CMS document.

In addition, the report concluded that the company had used expired regents for some of its prothombin time tests, according the WSJ.

Furthermore, CMS observed that the company's former quality-control manager was unqualified.

Theranos has requested that CMS not release the inspection report publicly alleging that doing so would compromise its trade secrets, according to the Wall Street Journal's anonymous sources.

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

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