Revolutionizing Blood Testing
Ken Auletta writes in The New Yorker about Elizabeth Holmes, a woman who's well on her way to "disrupting" medical testing with a cheaper, easier, less needle-scary blood test that will be available at Walgreen's and requires just a finger-prick:
When your physician wants to check some aspect of your health, such as your cholesterol or glucose levels, or look for indications of kidney or liver problems, a blood test is often required. This typically involves a long needle and several blood-filled vials, which are sent to a lab for analysis. Altogether, diagnostic lab testing, including testing done by the two dominant lab companies, Quest and Laboratory Corporation of America, generates seventy-five billion dollars a year in revenue.Holmes told the audience that blood testing can be done more quickly, conveniently, and inexpensively, and that lives can be saved as a consequence. She was wearing her daily uniform--a black suit and a black cotton turtleneck, reminiscent of Steve Jobs--and had pinned her hair into an unruly bun. As she spoke, she paced slowly, her eyes rarely blinking, her hands clasped at her waist. Holmes started Theranos in 2003, when she was nineteen; she dropped out of Stanford the following year. Since then, she told the audience, the company has developed blood tests that can help detect dozens of medical conditions, from high cholesterol to cancer, based on a drop or two of blood drawn with a pinprick from your finger. Theranos is working to make its testing available to several hospital systems and is in advanced discussions with the Cleveland Clinic. It has also opened centers in forty-one Walgreens pharmacies, with plans to open thousands more. If you show the pharmacist your I.D., your insurance card, and a doctor's note, you can have your blood drawn right there. (The sample is then sent to a Theranos lab.) From that one sample, Holmes said, several tests can be run--all less expensive than standard blood tests, sometimes as much as ninety per cent below the rates that Medicare sets. A typical lab test for cholesterol can cost fifty dollars or more; the Theranos test at Walgreens costs two dollars and ninety-nine cents.
...Holmes thinks that getting a blood test should instead be a "wonderful" experience, and the aim of Theranos is to lower the barriers. She told the crowd that between forty and sixty per cent of people who are ordered by their doctor to get a blood test do not. Diabetes, sexually transmitted diseases, and other common medical conditions could be diagnosed and treated earlier if the tests were less onerous and more accessible, she said. "We see a world in which no one ever has to say, 'If only I'd known sooner.' A world in which no one ever has to say goodbye too soon."
This is the innovation that America and what's left of capitalism makes possible -- that is impossible in places like France.
Of course, our government likes to step in and see that it's impossible here. As Auletta writes:
Last year, the U.S. Food and Drug Administration barred 23andme from disseminating some information out of concern that consumers might misunderstand or misuse it.
Do we really think someone who finds out they have a disease via a company like this is going to get up on the kitchen table and perform surgery on themselves?
We need to protect ourselves from a government that sees its job as protecting us from innovation and change. (Surely with a little help in the form of fuckloads of cash from its K Street status quo-maintaining friends.)
via KateC








Ok, dumb question time: Which of you Americans has had blood tests done lately? Did they really send your blood to some remote lab, and notify you of results days later?
The reason I ask: here (Switzerland) the lab is a box (about the size of a microwave) that sits in your GPs office. The nurse takes your blood, which may be a fingerprick if it's just one test, or several vials if they're doing a whole spectrum.
Ten or fifteen minutes later, they have the results. There's no huge wait, no sending blood off to some lab. I don't remember what the tests cost, but it's certainly not $50/test - maybe it costs that for a whole suite of tests.
It's been this way for years; this is nothing particularly new.
bradley13 at December 18, 2014 11:30 PM
I've had a ton of blood tests done this year and they have run the whole gamut of waiting times from 30 seconds while I waited to more than a week while my blood was sent half-way across the country.
There is a huge benefit to doing the tests immediately and it involves human error. One time I had 27 or so tests done at once in a busy office. They forgot one and I had to come back. Out of all those tests it was the only one that came back positive. I almost didn't go back after a 5 1/2 hour wait the first time.
Once again I had a test run and due to a mix-up the test ordered was never completed in a timely manner. Two weeks later they ran the test after my symptoms had resolved. The test was negative however my doctor wants to run it again if I ever have a flare-up because the markers can come and go even if a person has the disease. I had the exact test run before but once again the result is questionable because the test wasn't done in a timely manner that time either.
Jen at December 19, 2014 12:57 AM
Eliminate the part about showing ID and a doctor's note and allow anonymous cash payment and she might be on to something.
@ bradley13 - it depends upon the test (some tests require growing cultures, which takes time) but the "lab in a box" is a standard fixture of most veterinary practices in the USA. Sadly, as with many things right down to mouthwash (Chlorhexidine Gluconate mouthwash is prescription only for human use but over the counter in a veterinary formulation with the exact same concentrations of active ingredients) the disconnect between veterinary and human medicine is attributable only to cronyism and regulatory capture.
the other rob at December 19, 2014 4:58 AM
Amy Alkon
https://www.advicegoddess.com/archives/2014/12/revolutionizing.html#comment-5670848">comment from the other robThanks for mentioning that about the stupid doctor's note. I thought that was awful as I was reading it. Same for the "Showing ID."
Amy Alkon
at December 19, 2014 5:28 AM
Who pays for Congress? I'm not talking about the salaries, I'm talking about the millions it takes to run for office. That's who they work for.
MarkD at December 19, 2014 5:47 AM
I prefer the long needles over the pin pricks. The pin pricks really sting! And in the hands of a good phlebotomist, you rarely feel anything but a little pressure. However, I once had my blood drawn by someone new on the job. But she was so attractive that I didn't mind her poking holes in my muscle tissue while she was trying to locate the vein. It was still better than a pin prick.
Fayd at December 19, 2014 8:52 AM
Fascinating, great article, and interesting person.
I had routine blood work done recently, and had no idea that there are only two blood lab companies that do most of the analysis in the US. I would love to see how her system works and try it.
But as far as the big bad gov't goes, the article says that there is very little gov't oversight of blood lab industry. It's mostly in-house inspection. And the Holmes gal *wants* the FDA sign of approval, which isn't required, and the other labs don't even have.
Jason S. at December 19, 2014 9:46 AM
In all but a couple of states you don't need a doctor's order, note, prescription or whatever to have lab tests. A few labs will sell you lab tests directly, and you can order whatever tests you want through vendors on the internet. Try:
http://directlabs.com/
The internet vendors are middlemen. You order from them, pay with your credit card, print out your requisition and take it to a lab in your area. It's usually Lab Corp, one of the two biggest providers of lab services.
If you're paying for lab tests out of pocket the cheapest way to get them is through a clinic where you get your healthcare. If the clinic has a deal with a lab company and the clinic's nurses or med techs collect the blood from you themselves and send it to the lab some lab tests are amazingly cheap. Some tests, like hematocrit, blood sugar, cholesterol, pregnancy tests, drug screens or urinalysis, can be done right there and are often covered by the fee for the office visit.
The most expensive way to get lab tests is directly from the lab itself.
Getting tests through a healthcare provider or directly from a lab usually requires some form of permission from a doctor (not by law but by company policy) The doctor orders what he/she thinks you need, not what you think you need or would like to have, and may be influenced by pressure to cut costs.
The cost of ordering labs from a vendor on the internet is somewhere between the above two. Buying lab tests from Lab Corp through an internet vendor is usually cheaper than buying them directly from Lab Corp, even though the tests are done in the same lab.
It doesn't require any permission from your doctor to buy lab tests through the internet. However, included in the price the vendor will usually have a doctor review your results and give you brief feedback. Not a diagnosis, but pointing out any red flags or results you should follow up on.
If you have lab tests done yourself it's important to know that for many tests - i.e. liver function, lipids, thyroid, testosterone, estrogen, serum insulin - the "normal" range for tests doesn't mean optimal or healthy or good. The so-called "normal" range is just a reference range that represents +/- 2 standard deviations from the mean of some number of tests done at that lab over some period of time. The reference range can vary from one lab to another, and at the same lab from week to week or day to day. A lab test result isn't a diagnosis; it's just one piece of the information a doctor evaluates to determine a diagnosis. Some doctors are good at that and some not.
Ken R at December 19, 2014 11:46 AM
Elizabeth Holmes makes me think of Dagny Taggart, except for the inclusion of so many former big government functionaries on Theranos's board of directors.
Ken R at December 19, 2014 12:47 PM
"But as far as the big bad gov't goes, the article says that there is very little gov't oversight of blood lab industry. "
There is little federal regulation. As with most aspects of medical practice in the U.S., it is regulated at the state level. As you might expect, states vary in their rigor, but I've seen some of the process in Alabama and they are pretty darn thorough.
"I had routine blood work done recently, and had no idea that there are only two blood lab companies that do most of the analysis in the US. "
To a considerable extent, this was brought on by the federal government. It used to be pretty common for larger physician practices to own thier own labs. But the feds decreed this "vertical integration" and forced doctors to sell their labs. Additionally, lab equipment manufacturers used to have their own lab chains, e.g., Roche Biomedical. But again, the federal government decided this constituted an antitrust violation. That left Quest and Labcorp to snap up a whole bunch of suddenly no-longer-viable competitors.
Lots more to write about this, but I'm currently sitting in the ATL and I'm running out of time and battery charge. More later, if I get back to it.
Cousin Dave at December 19, 2014 1:05 PM
I'd like to be able to walk in and buy my own blood tests and results without having to show ID or get a doctor's order for it. I resent all the gatekeepers restricting access to everything.
BunnyGirl at December 19, 2014 1:23 PM
Additionally, lab equipment manufacturers used to have their own lab chains
Hmm, yeah, the article does say equipment manufacturers influence competition and is one reason for the two major labs.
Encouraging to learn that Holmes' lab can set up shop in 48 states, though.
Jason S. at December 19, 2014 1:48 PM
I don't know much about this, but it's a cautionary piece about prenatal screening via a loophole in FDA regulations.
http://features.necir.org/prenatal-testing
Jason S. at December 19, 2014 3:22 PM
I just tried to find a Theranos lab at a nearby Walgreen's - no luck. So I signed up for the mailing list in the hopes that the lab will open nearby soon. I'm annoyed that the option to identify as a non-medical professional is "patient," not "consumer."
In the U.S. there's a history of/ tendency to infantilize or otherwise subjugate people who seek (or are subjected to) medical treatment. I think that's reflected in the requirement to provide a doctor's note before handing over a part of one's own body in order to obtain information about one's own body. I'm not sure why this company requires a prescription, as I've purchased DIY sample-collecting kits and received results through the mail without a prescription.
Holmes' innovation is something my friends' kids are going to be able to replicate via 3D printing. Kids are going to be analyzing their blood at home the way my friends used to bake cakes in their bedrooms with EasyBake ovens. When I talk about the old days, when we'd have to ask a doctor for permission before finding out about and obtaining the drugs to alter our own body chemistry, they're going to look at me the way I looked at my grandmother when she told me she gave up the opportunity to be a showgirl in order to marry my grandfather. And I will envy them the way she likely envied me.
Michelle at December 20, 2014 11:54 PM
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