Theranos To Publish Data On Controversial Blood Test, FDA Not Impressed

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Theranos To Publish Data On Controversial Blood Test, FDA Not Impressed

Facing intense public criticism, the founder of the troubled medical testing company Theranos announced on Monday that data validating the accuracy and reliability of its blood tests would be released in the near future.

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Speaking at a conference at the Cleveland Clinic on Monday, Theranos CEO Elizabeth Holmes noted that presenting the data regarding the new lab test method would be more effective compared to the firm’s current efforts to try and rebut articles that she claims unfairly attacked the blood test and the company more generally.

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More on Elizabeth Holmes and recent Theranos problems

Holmes dropped out of Stanford University at age 19 to found Theranos, which has turned her into a billionaire who has been seen featured on the cover magazines because of her promise that her new “Edison” technology will provide rapid and inexpensive medical testing from samples of blood from a finger prick, instead of having to draw entire test tubes of blood.

Articles a week or so ago in The Wall Street Journal and other media sources, have opened up big questions about how well the technology really works or if can be effectively scaled up to hundreds of tests.

Attorney David Boies, in an interview after the story broke, noted the company had been doing a “minority” of its tests using its own Edison technology.

That means that the large majority of the tests are actually being done on conventional machines, and several former employees claim that the firm just dilutes the finger-prick samples it has to undertake the blood test results, which is a less-accurate measurement method.

The firm has been extremely secretive about its blood test technology, and has not yet published data on the technology in peer-reviewed journals.

In the interview, Holmes has said that Theranos was not against peer review, but was concentrating on submitting data to the FDA for approval, which she argued would represent the best validation.

However, it seems the FDA is not impressed, according to Vox Media – see the full filing here.

David Boies to become Theranos director

It looks like Theranos is taking additional steps to beef up its image. A company spokesperson confirmed late Monday that David Boies, a well-known lawyer who has been hired as Theranos’s external legal adviser, will now be joining the BoD.

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