Disrupting Diagnosis?

November 18, 2014

By Theo Schall



As you read this, there are hundreds of companies working to disrupt the traditional business of diagnosing disease. From the DNA Medicine Institute, whose device allows astronauts to diagnose themselves in space, to Theranos, which uses nanotechnology to make blood testing minimally invasive,  the testing industry has been flooded by small tech start-ups hoping to change how, when, and where patients can be examined. These new technologies aim for the superlative: testing that is cheaper, easier, faster, non-invasive, more flexible, more intuitive, more portable, open-source – better, in every way, than how we do things now. But what do these new technologies really mean for the future of medicine?



If the way we talk about something reveals how we think about it, the rhetoric these companies use is of two minds. Young CEOs speak with enthusiasm about democratizing markets, removing obstructions from the path of free individuals, breaking down the status quo. In her TedMed Talk, Elizabeth Holmes of Theranos emphasized her belief in a human right to engage with information about our own bodies. In a Wired article, Fay Christodoulou of Miroculus was quoted as saying, “We’re talking about a decentralized system; the main challenge is to make it robust enough so it can be done by an untrained person anywhere in the world in not-so-optimal laboratory conditions.” The story of new technology is one of empowered individuals unconstrained by the need for outside expertise. Why go to the doctor when you can run your own labs yourself? Why get sick at all, when you can discover your body’s weaknesses preemptively? More data means more freedom and more health.



Yet these same companies’ websites are much more careful to make medical providers and regulators feel comfortable that the world of medicine will remain recognizable. Elizabeth Holmes, whose company has already collaborated with Walgreen’s and whose board is packed with grizzled war hawks, has a great incentive to be mindful of the status quo – she also likes to use the drug commercial phrase “you and your doctor.” Rather than providing its technology to untrained people in sub-optimal lab conditions, Miroculus explains on its website that it “provides novel solutions for Academic Institutions, Genomic Research Centers, Pharma, Biotech and Diagnostics companies, so they can drastically improve their ability to diagnose, monitor and treat disease.” The reality of bringing expensive healthcare technologies to market requires that nimble new start-ups adapt themselves to the current medical system or risk failing entirely.



It’s understandable that emerging brands want to tailor their messages to their audiences. Tech-savvy investors and technology enthusiasts are, as a group, more invested in a neo-liberal or libertarian future where inefficient, paternalistic systems are overcome by the data-informed choices of rational actors. Outside of Silicon Valley, experts and patients alike are less interested in a paradigm shift than an improvement in outcomes. But we don’t know yet whether better diagnostic tools will make us healthier.



The FDA has made it clear in the past few years that it intends to impose more regulatory oversight to ensure the reliability of diagnostic tests. Misuse and overuse of diagnostic tests currently plague our health system, and while it’s true that making tests easier and cheaper will reduce the systemic burden, it will take some time for our analytic tools and therapies to catch up to a “new normal” of data collection. It seems unlikely that every lean start-up with an innovative diagnostic tool will succeed. Conditions favor the products of well-established companies like Google’s. Quality and safety assurance cost time and money, further hindering development, though successful companies take this into account. Hoping to improve the odds that their product would be a commercial success, Exact Sciences chose to simultaneously submit its colon cancer screening test to the FDA and Medicare, which is the single largest payer for health care in the country. Payment structures are inevitably crucial to the success of new technologies – a small tech start-up with an innovative test that insurance companies won’t cover is a small tech start-up that won’t make a lot of money.



Young companies interested in disrupting the status quo must find their way within the current system. Their products must meet regulatory standards, gain approval from payers, and either appeal to consumers directly or become so structurally entrenched that, like the current group of diagnostic companies, consumers are effectively left without a choice. By the time a new company has achieved success, it will be working from well within the industry it hoped to disrupt. Ultimately, it will be a while before we know if these technologies improve lives. It may turn out that this new class of diagnostic technologies represents less of a revolution than another step in the evolution of medical science and practice.

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Theo Schall

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