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I'm not entirely convinced that what Theranos is promising is even that great.

A couple weeks ago I got a blood test. I walked into the test center, which was staffed by a single person. I waited in line (there was one person in front of me), and told the person my name. She walked me over to a chair, drew enough blood for a whole bunch of tests, and that was it. I was in and out in 12 minutes (I timed it), and it was almost completely painless.

This wasn't Theranos. It was "Lab Corporation", an utterly non-unicornish testing center, and the local branch was staffed by a competent phlebotomist. It turns out that, once you stick a tiny IV needle in, you can draw a few vials of blood very quickly and painlessly.

In contrast, I once had a test at Theranos. The tech poked my finger with the magic lance (which stung more than the IV needle), put the little magic capillary collection widget over the drop of blood on my finger, and squeezed REALLY FUCKING HARD, repeatedly. My finger tingled weirdly for a few hours, because the REALLY FUCKING HARD squeeze hurt and probably broke a few capillaries. And the process took considerably longer than the blood draw at Lab Corporation. See, a little needle with a vacutainer at the other end draws quite a few mL of blood very easily, but a little finger prick struggles for more than a drop or two.

(Next time you give blood and get the finger-prick hematocrit test first, look at the tiny amount of blood that they get. Then imagine the rather large multiple of that amount that you'd need to fill the little Theranos collection widget. Ouch!)

I suppose if I were afraid of needles, then maybe the squeeze-the-finger-really-hard approach would have been an acceptable idea.




From experience, a blood sample which has been milked out of a finger is quite different to a venous blood sample.

(I am an anaestheologist and often perform or ask nurses to perform post-op point of care pinprick blood counts to look for anaemia in patients who have had big surgeries. We do 2 readings to check for error, and I often find that samples which have been squeezed out have a haemoglobin value 10-20% different to those which are drawn from a vein due to expression of tissue fluid.)


It seems that this isn't an issue for Theranos's FDA-approved HSV-1 assay. See Table 16 and Figure 1: http://www.accessdata.fda.gov/cdrh_docs/reviews/K143236.pdf

However, the skill level of whoever performed the fingerpricks for that data may be significantly higher than the average technician at Theranos's wellness centers. And of course we have no idea about the hundreds of other tests. There seems to be some other correlation data on Theranos's site (https://www.theranos.com/our-lab - scroll down to 'Representative Clinical Correlations'), but there's no captions or text to provide context.


Theranos definitely has an uphill battle against the ubiquity and cost efficiency of offsite testing labs but their technology is significantly different because it is an onsite test with a tiny amount of blood.

The infrastructure to support the kind of experience you're used to at Lab Corporation or Quest Diagnostics does not exist in much of the world. With the ubiquity of electricity and wireless broadband, a charity like Doctors Without Borders or Red Cross can drop a Theranos test device in a developing country and only have to worry about delivery of consumables to the location instead of shipping samples out, which requires a reliable postal infrastructure instead of a once a month delivery by airplane, boat, train, truck, or rickshaw for that matter.

I'm excited by Theranos' technology because the FDA has strict limits on how much blood you can draw from patients during a clinical trial. As our therapeutics get more and more complicated, we'll need a lot more data but the FDA will not raise this limit much, if at all, in the future. This is a known issue that you have to design around when running clinical trials, especially if you're developing something like a cancer cocktail where you might be looking for half a dozen metabolites and intermediary molecules in extremely low concentrations that each need a vial of blood. This isn't Theranos' target market (intermediaries/metabolites can be much harder to design tests for) but their tech's ability to test onsite with a tiny amount of blood might allow them to move into this market.


You're not thinking hard enough. Imagine you could do blood tests weekly from home cheaply? It could change all of medicine.




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