Microfluidics in the marketplace: Theranos makes its move

June 18, 2015
Will Elizabeth Holmes revolutionize clinical laboratory testing? Theranos, a Palo Alto, CA-based company that promises low-cost testing via microfluidic technology, was founded by Holmes in 2003 when she was a 19-year-old student, at Stanford. The year before as a freshman, she had been named one of the “President’s Scholars” and given a stipend of $3,000 to pursue a research project. She persuaded her chemical engineering professor, Channing Robertson, to use the money for a project in his lab, and later start a company. She used money that her parents had saved for her education, to establish Real-Time Cures in Palo Alto. Later, she changed the company’s name to Theranos (an amalgam of “therapy” and “diagnosis”).

Until recently Theranos has kept a relatively low profile, as the company apparently was busy refining its developmental, financial, and organizational systems. Then, in September 2013, an interview with Holmes appeared in the Wall Street Journal—an impressive debut for an organization that clearly wants to be a major force in American business—and a steady stream of media attention has followed. 

In February 2014 a question-and-answer interview with Holmes appeared at wired.com. The introductory paragraphs that precede the Q-and-A format espouse her creative ideals. “It’s a game changer…The implications are mind-blowing”– you get the idea. Holmes comes across as likable and self-effacing; when asked what motivated her to found Theranos, she jokes, “I definitely am afraid of needles. She quickly gets serious, however, and reveals the scope of her ambitions: “I started this company because I wanted to spend my life changing our healthcare system.” 

How does Theranos plan to do that? The company asserts that it has developed technology that uses the principles of microfluidics to create a new kind of testing. A micro-sample of blood, collected via fingerstick, would be loaded into a disposable cartridge and analyzed, and results would be sent to a secure database. Multiple tests could be run on a sample. Theranos claims that its processes will reduce pre-analytic errors and that results will be available to clinicians within a few hours. The company also says its laboratory is CLIA-certified.

She appears to be achieving some of her goals. In late 2013, the company began offering testing directly to consumers through a beta-testing arrangement with Walgreens. By early 2015, 40 pharmacies in the Phoenix, AZ area, and one in Palo Alto, were offering point-of-care testing. Some 250 tests are listed on the company’s website as available, including pricing which appears to average roughly half or less what an insured consumer might pay for a doctor-ordered test at an independent lab.In the meantime, Holmes has been getting remarkable exposure. Last year, Time magazine named her to its list of the world’s 100 most influential people. (I don’t know, Time, the world is a pretty big place.) Holmes was interviewed by CBS and CNBC, and a number of videos and interviews that feature her are picking up “views” on YouTube. She is literally the face of the company on its website. And at age 30, she finally received an honorary Doctor of Humane Letters degree from Pepperdine University after speaking at their commencement.

In May, Research and Markets released a report “Will Theranos Turn the Lab Industry Upside Down?” Introducing the report, R&M asks the key question: “Has Theranos scaled microfluidic technology across a comprehensive menu of tests?” That is, will it work? Will the company’s hardware and software do what it claims?

There is skepticism. In an opinion piece published in the Journal of the American Medical Association (JAMA) this past February, John Ioannidis, MD, a professor at Stanford School of Medicine, noted that Theranos’s claims of having creating technology for successful micro-testing have not been submitted for peer-review to scientific journals. There has been no independent review of the technology—just assurances from the manufacturer itself. Ioannidis also raised important questions about possible unintended consequences of the new testing model, including over-diagnosis and false positives.

But what if the company is finally able to back up its claims? The consequences could indeed be “mind-blowing.” With the reach of Walgreen’s behind it, Theranos could define a new paradigm for testing for millions of clinicians and consumers. The centralized clinical lab could find itself with new competition on a significant scope, greatly complicating outreach strategies. Demand for phlebotomists could suffer. Theranos could create a ripple effect throughout healthcare. I would be pleased to hear what you think.