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Comment by annnnd | Hacker News Reader

I don't have much experience with FDA, but it looks like they are arguing with technicalities. They are not saying that product is not working, just that it isn't approved by them (for this purpose, if Theranos website is to be believed [0] - "The Nanotainer™ and our devices have already been cleared by FDA for use with our HSV-1 test").

It looks like this could be solved very quickly if all parties were interested. I am quite sure that Theranos has made some powerful enemies, many of whom probably have some influence within FDA...

[0] https://www.theranos.com/news/posts/statement-from-theranos-...

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I assuming hsv-1 was approved and successful because it's a pcr test requiring very little blood already. Most of the other tests require much more volume. It sounds like these tests were the ones that were supposed to be revolutionary but were not successful.

Yeah, a PCR test can use a tiny sample, and and with a modicum of care it's not going to be subject to cross contamination in taking the sample (you do have to watch out for back-end contamination).

But I can see how things like lipid panels would have contamination problems with finger-stick draws, although they say they use a combination of those and "venous blood draws using smaller needles and smaller tubes", which doesn't strike me as a big selling point. In my experience, pain is associated with not hitting the vein right the first time, and once you hit the vein, you might as well draw more than enough for the planned tests and any followup tests ordered once the first results come in.

> although they say they use a combination of those and "venous blood draws using smaller needles and smaller tubes"

That's new, they used to claim they could do it all from their Nanotainer sample. It was and still is a crock, but that's entirely what Theranos' claim to fame is.

Yikes. And true per this cited on Wikipedia's intro page: http://www.wsj.com/news/articles/SB1000142412788732412300457... Here's what they're saying right now on https://www.theranos.com/our-lab

Our tests require less blood and less pain, regardless of whether we use our proprietary finger-stick technology or a venous draw.

We do venous blood draws using smaller needles and smaller tubes.

Now, I will say that when Quest does a venous draw they use a honking big tube ... well, the normal size since they stopped using syringes (you young whippersnappers are lucky, let me tell you!), and draw well more than a mL, but for the latter, who cares? Especially if that allows them to do followup tests without requiring another draw, as happened with me a couple of months ago. And for that matter, the larger the needle, the shorter the time is has to be in you to get a given sized sample.

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