The 30-year-old health sector billionaire
I think what is important is the LACK of critical articles out there. Where was the counterpoint in this article, or the recent Fortune article. I run a hospital laboratory in Seattle, and I am a clinical pathologist. Like Elizabeth Holmes, I studied Chemistry at Stanford, although I did graduate. Everyone in the lab world is a-twitter about Theranos right now, up to the CEOs of the big companies, largely because no one knows what they are doing. Everyone who goes and talks to them, including interviews for a job, signs a CDA, so this isn't surprising. However, there are several things we can know:
1- the big name folks on the board are Hoover Institution connections. No surprise there, I knew all those guys were there when I was at Stanford, and she was connected with them early. The person who commented about the importance for these links when it comes to FDA problems is right on.
2- what these people are doing for lab testing, in terms of technology, sounds totally revolutionary IF YOU DON'T KNOW ANYTHING ABOUT CLINICAL LABS. If you did know, you would understand that most of our routine instruments ALREADY use a couple microliters for an assay, and that results are available in seconds to minutes. There has never been an article about Holmes that mentions this. What she has done with microfluidics is to reduce dead volume quite a bit to allow overall lower sample volumes, but this is an evolutionary, not revolutionary, change to instrumentation. It is also of dubious clinical value (more on this later).
3- the fact that they list their prices IS revolutionary, and it's the best thing about the company. I wish I could do at for my lab. Secrecy of pricing is one of the major problems with Us healthcare.
4- no one writing any of these articles about her understands that fingerstick blood is not the same as venous blood. It is blood mixed with interstitial fluid from the tip of the finger. The results of tests are different for analytes in venous bold and fingerstick blood. Thus,they need to do a clinical validation that their results are meaningful, in addition to an analytical validation to prove that they're accurate. This is where the FDA, as they did to 23andme, is going to get involved, unless Don Rumsfeld can head them off. If LAb Developed Tests get regulated in the coming years, though, they are totally screwed, just like I am.
5- many people don't know that you can already get lab tests done on finger stick blood, ie prick your finger at home and mail in the blood or take it to participating Walmarts. The reason for this, I suspect, is that the companies that do this are not headed by an attractive blond woman and enveloped in the shroud of mystery of a Silicon Valley.I will be interested to see how long it takes before a serious "the emperor has no clothes" article will come out in a mass media outlet, and someone who actually runs a lab or knows any of the rules of running labs is asked even one question. It is much less sexy of a story when told that way, so maybe never.