Hi David, from the Wired article:

“But the Journal’s first article said that their tech wasn’t up to the task, and instead the company diluted the blood and ran it through standard industry diagnostic machines. The second article said the FDA outright recommended that the company stop using all but one test, for herpes simplex I—the only one the FDA has cleared for use outside of Theranos labs.”

http://www.wired.com/2015/10/theranos-isnt-the-only-one-chasing-needle-free-blood-tests/

On EQA, this gives some interesting insights:

http://www.fiercemedicaldevices.com/story/wsj-former-theranos-employees-reveal-problems-proprietary-testing-device/2015-10-16

Stuart

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I know this topic comes up on a semi-regular basis, but it is fascinating that there is so much “value” ($9bn) in something seemingly so clandestine. Yes, I know it is a commercial operation and there is the matter of intellectual and commercial confidentiality (yada yada), but I am left wondering (naively, perhaps, due to middle-age decline) about a few things. I have to admit that I have not read the WSJ article (other things to do with my money), but from the Forbes article I wonder:

1.       To market these test methodologies commercially, would they not have to produce at least a 510K submission to the FDA? If not, would there not be some regulatory requirement? I got the impression that this was (at least partly) their proprietary technology, so they are not quite in the same position as the local Wal-Mart doing cholesterol testing. And I can’t believe the same technology is used for HSV testing and K⁺, so one test does not cover all!

2.       What about EQA? If they belong to a scheme that data would be confidential, but do they belong to appropriate schemes? If yes, why not use this in their defence against the criticisms? (If not, why not?)

3.       Has anyone done what Carreyrou appears to have passed on, and sent comparative samples to them and a traditional contract lab (with traditional EQA)? I don’t recall ever seeing this mentioned.

Maybe I am missing something because, although still interested in the area, I am now doing other things. But these are obvious questions to me from my experience of analytical clinical biochemistry. If anyone can comment (if only to set right my personal ignorance) I would be interested in the replies.

Best wishes,

Dave

And also read this: http://onforb.es/1LPvfSW

Theranos' Elizabeth Holmes Needs To Stop Complaining And Answer Questions - Forbes

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