Since the dawn of modern medicine, patients have needed the doctor’s permission and expensive technology to receive almost any medical service, from routine blood testing to complex genetic sequencing. It’s just the way things are done. Blood tests are an integral part of healthcare and, according to the Mayo Clinic, inform 60 to 70 percent of healthcare decisions.
In recent years, though, a new echelon of companies has started to challenge the medical establishment with low-cost, accessible, self-directed products that can conduct hundreds of simple blood tests and can detect genetic predispositions for hundreds of serious illnesses. The importance of this patient empowerment and disruption of the traditional healthcare system is hard to overstate. It is also incredibly exciting.
Just as patients want more access to their health information, surveys also indicate that patients want more control over their healthcare decision-making. “More control” means everything from access to simple tests on-demand, without consulting a gatekeeper, to participation in shared decision-making with doctors over treatment options for complex, life-threatening illnesses.
The truth is that patients have always wanted more control over their healthcare, but now they are better equipped with the needed tools in the form of smartphones, patient portals and self-accessed diagnostic testing.
Theranos, which makes diagnostic kits that can perform all manner of blood tests in the home or at the neighborhood pharmacy, was founded 12 years ago by Elizabeth Holmes after she dropped out of Stanford. Although she had been quietly building the company for years, it was not until a 2014 profile in Fortune that Theranos and Holmes rocketed onto the public stage.
The Palo Alto-based company makes tests that require a few drops of blood instead of entire vials, and at a fraction of the price of office-based or lab-based tests. Dozens of Walgreens stores in Arizona, which recently passed a law allowing consumers to have blood tests without a doctor’s prescription, provide Theranos testing on a walk-in basis with results available within 24 to 48 hours through a secure patient portal. Dan Munro from Forbes has a detailed write-up on his personal experience with the service.
Theranos is also gaining momentum with recent FDA approvals for its methods and home-based testing. Although FDA approval is not required, it lends credibility to the technology and opens the door for more convenient testing in the future. “The more accessible care locations become, and the longer hours they are open, the better people can take control of their own health,” Holmes wrote in an op-ed for the Wall Street Journal earlier this year.
However, Theranos is now just as well known for its lower-cost, faster and less painful blood tests as it is for the secrecy surrounding its innovations.
Several experts, such as Dr. John Ioannidis from Stanford and Dr. Eleftherios Diamandis from Mount Sinai Hospital in New York, warn that the new excitement around Theranos should be met with caution and even skepticism. “Stealth research,” writes Ioannidis in the Journal of the American Medical Association, “creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements, and mass media hype.” Diamandis concludes that, “their claims of superiority over current systems and practices are speculative, at best.”
Observers have also raised concerns that patients, if given more liberty to seek out and see results of diagnostic tests on their own and without guidance from a trained doctor, might come to the wrong conclusions about what the tests mean. Most medical tests are known to have some “false positives” where the test indicates an alarming result that is not actually true. Most patients do not have the experience or knowledge to recognize false positives based on contextual information such as age and risk factors.
As a safeguard against these concerns, Theranos contends that it is physician-centric. It recently introduced MD Connect, which allows patients to consult physicians right after receiving their test results. Holmes says, “Our goal in providing more accessible, less expensive, and less painful diagnostic tests is to enable individuals and physicians to better engage early when interventions can be most effective.”
While Theranos is perhaps the highest-profile direct-to-consumer lab testing service, it is part of a crowded and competitive market of new and established players. Laboratory Corporation, the large diagnostics provider, rolled out online scheduling and a patient portal for viewing results. LabCorp hopes that the new patient-oriented services will enable it to compete with upstarts such as WellnessFX and Direct Laboratory Services, which provide most popular tests at a lower cost than traditional companies.
Another area of healthcare that used to be expensive and difficult to access, genomic sequencing, can now be obtained in a home kit for less than $100. 23andMe, co-founded by Anne Wojcicki, is the first name in do-it-yourself genomic testing and provides users with insight on their risk for hundreds of genetically-influenced diseases. Wojcicki told CBS in an interview: “If you know that you’re at higher risk for something, you can eventually screen better or you can eventually change your lifestyle so that will enable you to delay or prevent the onset of a condition.”
There is no doubt that a change is arriving to healthcare: patients are becoming more empowered and will soon expect, or demand, the freedom to control more healthcare decisions. It is crucial for the companies and healthcare providers to work together to provide responsible, meaningful and widely accessible services in order to realize that exciting future.
NOTE: The views expressed here are those of the authors and do not necessarily represent or reflect the views of Healthcare, Inc. and HealthCare.com.