This Woman Invented a Way to Run 30 Lab Tests on Only One Drop of Blood

WIRED ScienceBY CAITLIN ROPER 02.18.14 Mathew Scott; Hair and makeup by Raina Antle WIRED

Phlebotomy. Even the word sounds archaicand thats nothing compared to the slow, expensive, and inefficient reality of drawing blood and having it tested. As a college sophomore, Elizabeth Holmes envisioned a way to reinvent old fashioned phlebotomy and, in the process, usher in an era of comprehensive superfast diagnosis and preventive medicine. !hat was a

decade ago. Holmes, now "#, dropped out of $tanford and founded a company called !heranos with her tuition money. %ast fall it finally introduced its radical blood testing service in a &algreens pharmacy near the company head'uarters in (alo Alto, )alifornia. *!he plan is to roll out testing centers nationwide.+ ,nstead of vials of blood one for every test needed!heranos re'uires only a pinpric- and a drop of blood. &ith that they can perform hundreds of tests, from standard cholesterol chec-s to sophisticated genetic analyses. !he results are faster, more accurate, and far cheaper than conventional methods. !he implications are mind blowing. &ith inexpensive and easy access to the information running through their veins, people will have an unprecedented window on their own health. And a new generation of diagnostic tests could allow them to head off serious afflictions from cancer to diabetes to heart disease. .one of this would wor- if !heranos hadnt figured out how to ma-e testing transparent and inexpensive. !he company plans to charge less than /# percent of the standard 0edicare and 0edicaid reimbursement rates. And unli-e the rest of the testing industry, !heranos lists its prices on its website1 blood typing, 23.#/4 cholesterol, 23.554 iron, 26.6/. ,f all tests in the 7$ were performed at those -inds of prices, the company says, it could save 0edicare 258 billion and 0edicaid 29#6 billion over the next decade.

Object 1

&hat was your goal in starting a lab testing company:

&e wanted to ma-e actionable health information accessible to people everywhere at the time it matters most. !hat means two things1 being able to detect conditions in time to do something about them and providing access to information that can empower people to improve their lives. !here are a billion tests done every year in the 7nited $tates, but too many of them are done in the emergency room. ,f you were able to do some of those tests before a person gets chec-ed into the E;, youd start to see problems earlier4 youd have time to intervene before a patient needed to go to the hospital. ,f you remove the biggest barriers to these tests, youll see them used in smarter ways. &hat was your motivation to launch !heranos at the age of 95: &hat set you on this road: , definitely am afraid of needles. ,ts the only thing that actually scares me. <ut , started this company because , wanted to spend my life changing our health care system. &hen someone you love gets really sic-, most of the time when you find out, its too late to be able to do something about it. ,ts heartbrea-ing. =oure not alone in your fear of needles. (hlebotomy is such a huge inhibitor to people getting tested. $ome studies say that a substantive percentage of patients who get a lab re'uisition do not follow through because theyre scared of needles or theyre afraid of worrying, waiting to hear that something is wrong. &e wanted to ma-e this service convenient, to bring it to places close to peoples homes, and to offer rapid results. &hy the focus on rapid results: &e can get results, on average, in less than four hours. And this can be very helpful for doctors and patients, because it means that someone could, for example, go to a &algreens in the morning to get a routine test for something their doctor is trac-ing, and the physician can have the results that afternoon when they see the patient. And were able to do all the testing using >ust a single microsample, rather than having to draw a dedicated tube for each type of test. $o if , got a blood test and my doctor saw the results and wanted other tests done, , wouldnt have to have more blood drawn: Exactly. And on their lab form, the physician can write, ?,f a given result is out of range, run this follow up test.@ And it can all be done immediately, using that same sample.

Todd Tankersley Brown Bird Design $ome conventional tests, li-e pH assays, can be done 'uic-ly. Athers, li-e those that re'uire culturing bacteria or viruses, can ta-e days or even wee-s. Are there some tests that ta-e !heranos longer: )an everything really be turned around in four hours: =es, we had to develop assays or test methodologies that would ma-e it possible to accelerate results. $o we do not do things li-e cultures. ,n the case of a virus or bacteria, traditionally tested using a culture, we measure the B.A of the pathogen instead so we can report results much faster. &here do you see this ma-ing a big difference: Certility testing is a good example. 0ost people pay for it out of poc-et, and it can cost as much as 23,###. !hese tests provide the data you need to figure out someones fertility, and some women cant afford them. Aur new fertility panel is going to cost 2"/. !hat means women will be able to afford the tests. !heyll be able to better manage the process and ta-e some of the stress out of trying to conceive. &hat are you doing to ensure the accuracy of your testing: !he -ey is minimizing the variability that traditionally contributes to error in the lab process. .inety three percent of error is associated with whats called pre analytic processing generally the part of the process where humans do things. $uch as: 0anually centrifuging a sample or how much time elapses before you test the sample, which brings its decay rate into play. $o how do you avoid these potential errors: !heres no manual handling of the sample, no one is trying to pipette into a .anotainer, no one is manually processing it. !he blood is collected and put into a box that -eeps it cold. !he very next thing that happens is lab processing, and thats done with automated devices at our centralized facility with no manual intervention or operation. How can improved processes actually save lives: &eve created a tool for physicians to loo- at lab test data over time and see trends. &e dont usually thin- about lab data this way today. ,ts ?Are you in range, or are you out of range:@ ,nstead, we li-e to thin-, ?&here are you going:@ ,f you showed me a single frame from a movie and as-ed me to tell you the story, , wouldnt be able to do it. <ut with many frames, you can start to see the movie unfold. How else can you use this technology:

0any, many years of wor- went into ma-ing this possible. &e started our business wor-ing with pharmaceutical companies. <ecause we made it possible to get data much faster, they could use our infrastructure to run clinical trials. !hey were also able to run whats called an adaptive clinical trial, where based on the data, they could change the dosing for a patient in real time or in a premeditated way, as opposed to waiting a long period and then deciding to change a dose. ,n the long run, what impact will your technology have: !he dream is to be able to help contribute to the research thats going on to identify cancer signatures as they change over time, to help intervene early enough to do something about an illness. &ill people become more used to gathering and examining their own health data: .o one thin-s of the lab testing experience as positive. ,t should beD Ane way to create that is to help people engage with the data once their physicians release it. =ou cant do that if you dont really understand why youre getting certain tests done and when you dont -now what the results mean when you get them bac-. ,t drives me crazy when people tal- about the scale as an indicator of health, because your weight doesnt tell you whats going on at a biochemical level. &hats really exciting is when you can begin to see changes in your lifestyle appear in your blood data. &ith some diseases, li-e type 3 diabetes, if people get alerted early they can ta-e steps to avert getting sic-. <y testing, you can start to understand your body, understand yourself, change your diet, change your lifestyle, and begin to change your life.