What if you could get a blood test done for less than $20, with no doctor’s order, no syringe, losing just a few drops of blood, and see the results within hours? Theranos is a Silicon Valley company that spent the last decade making this possible, and disrupting the $75-billion diagnostic lab test industry. Here are nine ways Theranos is affecting diagnostic testing.

  1. Cost As CEO Elizabeth Holmes told The New Yorker, a typical lab test for cholesterol can cost fifty dollars or more, while the Theranos test at Walgreens costs $2.99. Theranos offers more affordable tests across the board and lists all test prices on their website.
  2. Convenience Theranos has partnered with Walgreens, which now hosts in-pharmacy diagnostic testing labs at locations in Arizona and California. Based on a long-term partnership set up in 2013, Walgreens will eventually host Theranos diagnostic tests in most of its 8,232 stores across the country. Holmes says this will put convenient and affordable diagnostic testing within five miles of almost every American.
  3. Comfort No syringe and less blood might mean more people get tested. While there’s some debate about the statistics, Holmes says that 40-60% of people who are ordered by their doctor to get a blood test do not, which delays diagnosis of common medical conditions that are better treated if caught earlier. It’s not clear whether or not the poor follow-through rate is because of fear of needles.
  4. Consumer Lab Testing Earlier this year Arizona passed a Theranos-backed law that gives patients the “most robust and explicit rights in the country” to order lab tests without having to go through a doctor. As Fortune reports, this supports Holmes’ goal of advancing preventative medicine and may serve as a model for other states.
  5. Secrecy Many observers are troubled by Theranos’ secrecy, especially a lack of peer-reviewed data describing how its devices work and the quality of the results. While CEO Holmes says they are just trying to protect themselves from competitors and do something unique, there are ethical concerns that make this approach less acceptable in health care than with a product like Apple’s iPod. Theranos is certified in forty-eight states, so they do adhere to federal legislation and are evaluated three times a year by the College of American Pathologists.

    While lower cost, more convenient and comfortable consumer lab testing has clear benefits, there are also some aspects of Theranos’ model that raise difficult questions.

  6. Regulation Technically diagnostic tests don’t need FDA approval, which puts Theranos in an unusual regulatory grey area. Big diagnostic test companies, like Quest and Laboratory Corporation of America, usually buy equipment from manufacturers who need FDA approval to sell that equipment; but since Theranos manufactures their own equipment there is no external review. The company actually submitted its lab-developed tests for FDA approval voluntarily, but since no other diagnostic company has done this its unclear if the FDA has a mechanism to respond to that request.
  7. Doctors The biggest question is how consumer initiated diagnostic tests get incorporated into patient care. Should Theranos require test results to be sent to physicians? Will patients want their doctor to know? Doctors are legally obligated to follow up with patients about abnormal blood tests, but will Theranos be held to that standard?
  8. Insurance Will insurance companies reimburse for patient-ordered blood tests?
  9. Disruption Just as Theranos is disrupting the diagnostic test industry through miniaturization, other products and techniques on the market could disrupt Theranos. One example is point-of-care testing (like Alere TRIAGE), a technique for bedside blood tests that produces nearly immediate results. Working on the same principles as Theranos’ in-pharmacy labs, point-of-care brings the test conveniently and immediately to the patient. Lots of companies are also exploring tests that don’t require needles, using lasers, oximetry, biosensors, and medical imaging like MRIs.

Much has been written about Theranos CEO Elizabeth Holmes, now the youngest female billionaire who dropped out of Stanford at age 19 to disrupt diagnostic lab testing. If you want to know more, The New Yorker has a great piece about her journey and her company. But the implications for health care are much bigger than just the Theranos story. They requires us to ask, “what happens when consumer lab testing and in-pharmacy labs replace traditional diagnostic testing?” Because it seems like only a matter of time.

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