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U.S. Food and Drug Administration

Now no doctor's note needed for blood test in Arizona

Marco della Cava
USA TODAY
Theranos Wellness Center program manager Ryan Karpel stands inside a clinic inside Walgreens in Scottsdale, one of dozens of locations where come July 3 residents of Arizona can go to get blood tested without a doctors' note.

SAN FRANCISCO – The Fourth of July may be the big holiday for the rest of the nation. But for Theranos founder Elizabeth Holmes, July 3 is party time.

On Friday, an Arizona law co-authored by Holmes' high-tech company goes into effect, allowing patients to order blood tests without involving a doctor. It represents a significant step towards Holmes' ultimate mission: giving consumers control over monitoring their health via inexpensive and comparatively painless tests.

"This bill demonstrates that we can facilitate a new era between physicians and patients," Holmes tells USA TODAY. "If people begin to engage, they can test and monitor their health before they get sick."

Theranos' calling card is the ability to run tests based on a finger prick, using not vials but mere drops of blood that are collected in its patented Nanotainers. The vials along with Theranos' testing procedures received Food and Drug Administration approval Thursday.

A simple finger prick would appeal to both the squeamish and those requiring frequent tests, while Theranos' transparent and low pricing – it offers more than 100 tests at less than $10 – is meant to eliminate cost as a reason for not being tested.

The new Arizona law, which was signed by Republican Gov. Doug Ducey in April at a Theranos lab in Scottsdale, allows patients to order any blood test they want without a doctor's referral. In addition, the law protects physicians from being sued as it places the onus of interpreting test results on patients.

Holmes says the idea isn't to cut doctors out. Friday also marks the launch of Theranos MD Connect, an online resource that puts Arizona test result recipients in touch with primary care physicians around the state.

"The bill deliberately protects physicians (from lawsuits), but we are all for making sure patients partner with them in a productive context," says Holmes. "People need to be in control. I liken it to a pregnancy test. You wouldn't go to your doctor to get approval to take a test. You'd take the test and go to the doctor. All of this is just about having the access to your own health."

Theranos has its critics. In February, Stanford University School of Medicine professor John Ioannidis scolded the company in a Journal of American Medical Association editor of "stealth research" and called upon the company to be more forthcoming about its equipment and testing methods.

"Theranos is just one example among many for which major efforts and major claims about biomedical progress seem to be happening outside the peer-reviewed scientific literature," Ioannidis wrote. "The main motive appears to be to develop product and services, rather than report new discoveries as research scholarship."

Representatives of Theranos' main rivals in the blood testing business, Quest Diagnostics and LabCorp, did not respond to requests for comment on Theranos and the new Arizona law. Holmes simply says that "many things have been written about us that are just completely false. We're just saying that enfranchisement leads to understanding."

In fact, Theranos' blending of technology and health is far from novel.

So-called telemedicine – where doctors and patients consult online or by phone for a fee – is a growing trend, while new health care insurers such as New York-based Oscar are using smartphone apps and other tech to make the enrollment process more transparent and doctor interactions easier to facilitate.

Theranos founder Elizabeth Holmes holds one of her bloodwork company's FDA-approved Nanotainers, where mere drops of blood are stored for complex tests.

"This (bill) is a major step for Theranos and its plans and the FDA news does validate Theranos' core competency, but there is still a long road ahead," says Eric Lakin, biotech analyst with DeciBio who has been following the Palo Alto startup. "My biggest concerns would be around the interpretation of (blood work) results when there are urgent anomalies."

For Eric Meyer, a former emergency room physician and now Arizona's House Minority Leader and member of the state's House Health Committee, Theranos' next step in his state could ultimately lead to reduced health care costs.

"As a physician, I like the idea of people taking a more active role in managing their health, but as a legislator I'm even more excited about the possibility of health care savings," says Meyer. "Theranos won't make a difference if you don't need blood work often. But if you do, it changes the game."

That's precisely the case for Sandy Crytzer and her Cole, 8, who used to be terrified of getting his blood drawn. After reading about Theranos online, the Phoenix resident went to her nearby Walgreens and hoped for the best.

"Cole has Asperger's (a form of autism) and has sensory issues, and giving blood was miserable for him," says Crytzer. "But at the Theranos lab, Cole was put in control."

She says the technician did not rush the process and the result was that her son now asks to go back. "He feels like a big boy," she says.

Crytzer adds that Theranos has also made checking on her thyroid issue easier. Instead of making an appointment with a doctor to get the go-ahead for blood work, "all of which took weeks," she finds herself being far more proactive about keeping her condition in check.

That's the sort of testimonial that makes Holmes happy to jump through the hoops that will no doubt continue to be placed in Theranos' path as it continues to push in considerable secrecy to win its share of the $60 billion-a-year blood testing industry.

"For us, it's never been about what other (companies) are doing, it's about early disease detection," she says, adding that Theranos may be announcing roll-outs in other states soon. "We're taking the crawl, walk, run model, building our foundation slowly and solidly. There is nothing more important to me than this."

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