Blood Business

Written by Wynter Holden Category: Valley News Issue: May 2015
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Disruptive tech company Theranos launches a pilot program in Arizona that may revolutionize blood testing – and that needles the competition.

Sweaty palms. Nausea. Racing pulse. What sounds like classic heart attack symptoms could just as easily describe the terror some patients experience while awaiting a simple blood draw. According to the Journal of Family Practice, approximately 10 percent of the population suffers from some level of trypanophobia, or fear of needles.

Elizabeth Holmes, founder and CEO of Silicon Valley laboratory testing company Theranos – which has launched a revolutionary pilot program in Arizona – is very outspoken about her aversion to needles. “That’s the only thing in my life I think I’ve actually genuinely...  been afraid of,” she admitted in a 2014 video for USA Today. This common fear of the standard venipuncture – which requires large needles and intravenous penetration to procure one or more vials of blood – prompted Holmes to develop alternatives such as finger-prick draws and micro-sampling that require only a few drops of blood in a 1.29 cm tube, with comparatively little intrusion.

The technology behind laboratory blood testing hasn’t changed much since the 1960s, but the industry has recently seen innovations that allow for easier and more patient-friendly processing. In early 2015, Ireland’s Radisens Diagnostics unveiled new “clinic-in-a-box” technology that processes blood using a finger-prick sample collected in a small cartridge. The process is similar to Theranos’ micro-collection procedure, which offers results for 30 individual tests from a single drop of blood on a microchip.

Since its inception in 2003, Theranos has been working toward making major changes in the industry. Holmes reportedly raised more than $400 million in venture capital; has a board that includes former United States Cabinet stalwarts Henry Kissinger and George P. Shultz; and at 31 years old, is America’s youngest self-made female billionaire (estimated net worth: $4.5 billion). Last year, Theranos leased a 20,000-square-foot wing at SkySong in Scottsdale, after partnering in 2013 with Walgreens to create a network of in-store wellness centers in Northern California and throughout the Phoenix metro area. There are currently 40 centers in Arizona. Holmes hopes to eventually have a center within five miles of every Arizona home. Opportunities for national expansion are in development.

Though Holmes was unavailable for comment, Theranos spokesman Jeffrey Blickman says Arizona was chosen as a test market for the Walgreens program for its “standing as a national leader in healthcare innovation and the cost-saving opportunity to Medicare and Medicaid due to the representative population in the state and the low costs of our tests.” Theranos’ pricing is one of the largest draws of the Walgreens clinics, with tests costing as little as $2.99 for a cholesterol screening in comparison to the $50 or more found elsewhere. The company’s less invasive methods and reportedly faster-than-usual results also appeal to consumers.

But not everyone is keen on Theranos’ testing model – or even believes its claims. Visits to Walgreens testing centers have yielded mixed results, with many patients reporting that blood vials were collected via venipuncture instead of the promised finger prick. According to Joyce Santis, Chief Operating Officer of Sonora Quest Laboraties, the technology does exist to test minute samples of blood. But she says there’s a downside to working with limited fluid samples.

This small drop of blood is about the same amount needed for a Theranos blood test.

“A finger-stick is one of the less desirable samples to take,” Santis says. “You always try to have enough to repeat a sample in case you have to rerun it. Rather than having the patient come back, we can retest. Plus, any time you have to apply pressure and squeeze or push, you’re pushing tissue into the sample and potentially diluting it.” With more than 6,000 clients and 70 service centers statewide, Sonora Quest is Theranos’ biggest Arizona competitor. Santis’ issue with Theranos is the lack of public information about the company’s furtive technology and secretive testing process. “I would like to see more transparency,” Santis says. “It’s great to have something new and cutting-edge... disruptive technology... but in healthcare we need to understand it.” From her viewpoint, it isn’t just about the solid statistics expected by industry professionals. It’s also about fully informing the consumer of what to expect.

Holmes has responded to concerns about Theranos’ secrecy, and assertions from outsiders that the company should publish more information about its methods. She points out Theranos seeks FDA approval for all its laboratory-developed tests, though it is not required to do so. “We understand that our competition would like us to tell them how we do everything that we do... [but] no lab goes out there and does a publication that says, ‘My lab test works,’” she told Michael Krasny in an interview for the Computer History Museum’s Revolutionaries speaker series. “The regulators make sure your lab test works.”  

Blood testing is a growth industry in Arizona, where politicians such as Rep. Heather Carter are pushing a bill designed to give consumers more power. Under current Arizona law, residents can order limited lab tests, including urinalysis and cholesterol levels, on their own. Other tests, ranging from thyroid hormone levels to certain STD screenings, require a doctor’s order. Facilities like Any Lab Test Now circumvent this restriction by offering immediate test referrals through in-house physicians.

This clever workaround may soon be unnecessary. In late March, Carter’s House Bill 2645 had been unanimously approved by the House and the Senate and progressed to the governor. Holmes testified in favor of the bill at a Senate Health and Human Services Committee meeting in March. “I believe very strongly it’s a basic human right for every person to be able to have access to health information if they want to use their own money to pay for it,” said Holmes, addressing the committee in her signature austere black jacket and turtleneck.

Holmes says her commitment to the accessibility of blood testing was inspired by the untimely death of her uncle as a result of skin cancer that might have been treatable. “If you have the ability to find out earlier, there’s so much you can do,” she told Arizona lawmakers. But she also understands that affordable pricing is key to getting Arizonans tested in time to make a difference. Cost is an integral component of Holmes’ push for “direct access” to healthcare information. Price lists are published by Theranos and Sonora Quest (as well as walk-ins like LabCorp, Any Lab Test Now and Lab Xpress), with Theranos’ pricing undercutting Medicare rates by 30 to 90 percent.  

The new law would allow patients to walk into a lab and order any test offered. This increased availability, combined with pricing transparency, means educated consumers will likely be shopping around for affordable lab tests. With Theranos’ rock-bottom pricing, it could be difficult for other Valley labs to compete.

In a statement issued by Chief Legal Officer F. Samuel Eberts III, nationwide testing service LabCorp disagreed with the idea of allowing patients free reign. “We have long supported making test results available to patients, and we support the democratization of lab testing, but not all tests and results are created equal,” Eberts says. “Some test ordering and result delivery are most appropriately handled through the traditional doctor-patient relationship.” This viewpoint is especially prevalent among physicians who worry patients will misinterpret results or pay for unnecessary tests after looking up symptoms on the Internet.

Other medical professionals support increased access to testing, including Dr. Matthew Baral of Southwest College of Naturopathic Medicine, who testified alongside Holmes in favor of HB 2645. “There is already so much information available to patients online and through confidential testing centers,” he says. “The law will give people easier access to their health information without going through hoops.”

With low advertised costs, minimally invasive technology and readily available tests, Theranos is poised to give Arizona’s big-name blood labs a run for their money. “If it’s as accurate as conventional testing, one-tenth the price and an easier specimen to collect,” Dr. Baral says, “then it’s a no-brainer to utilize [Theranos’] technology.”

 

Testing, Testing
How Theranos’ prices for blood tests compare to the competition.

Glucose levels
$49 (Any Lab Test Now)
$25 (Sonora Quest)
$2.70(Theranos)

Thyroid panel
$98 (Sonora Quest)
$79 (Any Lab Test Now)
$49.95 (Theranos)

Lipid panel
$49 (Any Lab Test Now)
$42 (Sonora Quest)
$9.21 (Theranos)

Testosterone levels
$79 (Any Lab Test Now)
$65 (Accesalabs)
$17.50-$17.75 (Theranos)

*prices reflect test menus published on each company’s website and are subject to change