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Science Reviews

The Market for Easy, Quick Blood-Testing is Ready Even if Theranos is Not

Health

Theranos test menu

The take-home lesson from the Theranos fiasco is that unlike the emergence of other technologies that many did not see coming, the market for easy DIY tests exists, is huge and is waiting. Take over-the-counter pregnancy tests, they are popular and have become the norm, because women trust that most of the time they work reliably and accurately. What we can also learn from the Theranos controversy is that even when the market is ready, there is a need to wait when a new technology is not ripe or to be more exact, when it is flawed and the errors have greater consequences. When a computer or smartphone fails to turn on, it is an annoyance, but it is not comparable to getting a false result on a medical test. A false positive, as an erroneous positive test is called in statistics, can lead to worrying, spending time and money on doctor visits, and on more tests. Technologies that involve medical diagnosis and test kits need to be evaluated thoroughly even if the market, the public and investors clamor to get it now.

According to Theranos Yelp reviews, which seem legitimate because they involve complaints, it is clear what customers were looking for: “I can’t imagine going back to the way it was before when everything had to go through a doctor’s office for a lab order” and “very easy draws, and super fast results –  through an app no less”, and avoiding the wait at medical diagnostic offices. Together with the millions in funding that Theranos got, it shows that it is only a matter of time before the flood gates of self-measurement and personal health data collection and storage open wide. When that happens, medicine as we know it today will change. This leads us to consider the reasons that propelled Theranos to become the darling of biotech investments and the reasons that blindsided Walgreens into closing a rushed deal with a company they did not vet.

Theranos started off as the feel good story of young scientific entrepreneurship until a few years ago.  A startup who surged on the hype of open science and novel medical breakthroughs and on the success of venture capital funding rounds that amassed $70 million in its first 10 years. According to an article in Forbes, Theranos was valued at $3.6 billion as of March 2016.

Unfortunately it is also the story of a company that rushed their technologies and services to market without undergoing thorough clinical trial testing or being subjected to peer-review scrutiny until now. Everybody likes a good story and the young founder of Theranos, Elizabeth Holmes, provided a compelling character that elevated the story to massive media attention.

But when it comes to medicine, we also need a story that is true or a method that works. As a contrasting example, the startup Evena Medical Inc , inventors of a vein locating device, spent years testing an early version of the concept to make sure it worked on all skin types and skin colors.

Theranos published no data in medical journals. Theranos claimed to have conducted clinical trials with Pfizer and GlaxoSmithKline but the two pharma companies deny having done than more than limited exploratory work early on.

Blood testing is a complicated business and making it easier, faster and more accessible to all without the insurance red tape will benefit all of us. But it must work. The results have to be accurate. We hope that Mrs. Holmes will fulfill her promise to take the necessary measures to fix the problems, and when they make their testing kits accessible to regular citizens, or another company beats them to it, that we can trust that the results are correct. The reliability of the first medical self-test technologies will determine the enthusiasm and support that other emerging biomedical self-service technologies will receive in the future. Walgreen is now reportedly teaming up with 23andme to sell their genetic testing kits, and 23andme, having been at it for many years while also negotiating with the FDA, has a better track record of producing sound results. We need strong success stories in order to open up the currently restricted world of life sciences to everybody.

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