This story undoubtedly sounds familiar: earlier this month, a tech start-up company presented a low-cost, open source invention at a TED conference. The device is made with a 3D printer and uses an iPhone app to communicate with the cloud. Its inventors even met at Singularity University, the elite Silicon Valley philanthro-capitalist thinktank. Like every new tech innovation, this one’s future is hardly assured, but the bioethical questions it poses are sure to linger.

 

The company, Miroculus, plans to overhaul cancer screening by making it easier, cheaper, and more comprehensive. Its device, dubbed “Miriam,” uses a blood sample to detect micro RNAs, also known as “miRNAs.” miRNAs are a class of small molecules that appear and disappear based upon what is happening in the body, making them potentially ideal biomarkers for disease. Miroculus hopes to eventually be able to test for up to 200 cancers in about an hour, making regular comprehensive screening practical for every patient.

 

Miriam’s inventors didn’t discover miRNAs. First found in 1993, it took molecular biologists a while to recognize the importance of the discovery. Over the past decade, thousands of papers have been published on the relationship between miRNA expression and disease. We now know that the presence of specific patterns of miRNA indicates the presence of disease. Unfortunately, because testing remains prohibitively expensive and slow, your physician isn’t likely to order a miRNA testing assay as part of your annual physical.

 

This is also because we don’t yet know how to use miRNA to screen accurately. Cancer is not the only thing that can change miRNA – so can medicines, environmental conditions, and less serious diseases like colds. A biomarker whose function we don’t fully understand is not quite ready for primetime. In his TEDGlobal talk, Chief Technology Officer Jorge Soto admitted that the company has so far successfully identified the microRNA patterns of only four cancers. Miroculus has partnered with pharmaceutical companies, offering up the device for cancer screening studies in exchange for a new wealth of data on its efficacy. The first clinical trial using Miriam is underway now in Germany.

 

Yet while Miriam’s success is not assured, the device certainly points to the future of diagnostics. It seems inevitable that this or another technology will eventually bring minimally invasive, inexpensive disease screening to us all. Soon, we’ll be able to track how our bodies respond to treatment in real time. We’ll know at a molecular level how our bodies are and aren’t working. And inevitably, this new world of diagnostic medicine will bring diverse ethical challenges.

 

If we run too far from medical paternalism’s past, we may find ourselves lost and alone, without help or guidance. Miroculus has been keen to promote Miriam on the basis of the device’s “democratization” of medical testing. This is no doubt a compelling selling point for Silicon Valley investors, but it points immediately to questions of oversight, quality control, treatment protocols, and patient support. If a patient is tested remotely or by minimally trained professionals, who will help make sense of the results? What happens if a seemingly healthy patient is found to have a serious disease? What about incidental findings? Who will guide treatment choices and provide compassionate care?

 

Lowering the prohibitive cost of medical testing opens the technology to populations and nations that can’t afford it. Yet our medical system, which already overtests and overtreats, offers this lesson: testing is not, in itself, always a benefit. The desire to do something, to test and treat even when nothing is wrong or the prognosis is bad, can have devastating results. And while “democratized” diagnosis may be more accessible to poor patients, the cost of treatment may remain too high. Is it helpful to have better diagnostic tools without better access to treatment?

 

As ever in this world of Big Data, we must worry about privacy and security. Miriam uses cloud-based databases to analyze diagnostic information and store longitudinal results. While these kinds of systems already exist, the expansion of medical testing will be accompanied by exponential growth in the amount of private medical information recorded about each patient. It may not be cause for alarm, but we must approach developing diagnostic infrastructure with awareness of the costs of close surveillance. Who will have access to this data? How will it be protected?

 

It’s likely that we’ll soon need a new vocabulary for disease itself. We know already that we all have cancer in our bodies all the time – how will we talk about who is sick and who is well when we have a more complete understanding of the body’s moment-by-moment balancing act? And as language changes, so will behavior. Perhaps we will be more supportive of “healthy” people fighting off infection or more understanding of those challenged by atypical brain chemistry. Perhaps the binary understanding that we have now – the Sick and the Healthy – will turn out to be a childish oversimplification. Of course, it’s difficult to predict the future of technology and even more so to imagine how our social and cultural norms will adapt themselves to it. What we do know is that ethical deliberation must advance in step with evolving medical technology.

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Theo Schall

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