21 October 2015

Scandal over miracle blood testing startup must not halt progress


It’s nearly a year since CapX covered Theranos, the miracle startup that was upending the $75 billion blood testing industry by using pin-prick technology. Founder Elizabeth Holmes figured out that most people don’t like having syringes stuck into them, and built a $9 billion company based on making blood tests quicker, cheaper and less painful.

As someone who is violently needle-phobic (I have literally run away and ended up in hospital carparks rather than endure a basic blood test), I have been watching Theranos with excitement. And I was therefore particularly disturbed when, last week, the Wall Street Journal ran an exposé on the company, uncovering a range of worrying problems.

For those without enough time to read John Carreyrou’s whole piece, here’s the gist: Theranos’ wonder-device (named ‘Edison’), which requires just a pin-prick’s worth of blood taken from the patient’s finger, is unreliable. Out of the 240 different tests the company offers, he writes that Edison is used for just a fraction (15, according to a former employee mentioned in the WSJ article, although Theranos has denied this), with the rest performed by equipment bought from other medical suppliers. To make the traditional tests work with only the small sample of blood provided, it is claimed that it is diluted which can compromise results. When the Edison device does perform the tests, the results can be inaccurate: “Some of the potassium results at Theranos were so high that patients would have to be dead for the results to be correct, according to one former employee.”

In addition, the WSJ reveals evidence to suggest that Theranos may have misled regulators by using these other machines when running samples for mandatory “proficiency-testing” which labs must perform to prove they can produce accurate results. It is not clear whether this would be a breach of regulations, although it certainly raises concerns.

Theranos has come out fighting, issuing a statement calling the WSJ’s story “factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents”. Elizabeth Holmes has appeared on CNBC, saying she was “personally shocked” that the WSJ had published, and claiming Theranos had sent in “more than 1000 pages” of documentation to refute the claims.  But neither she nor her company has so far commented on whether the concerns over the Edison technology are true.

Why does this matter, if you’re not an investor or healthcare professional in the US? Because this kind of technology should work. The syringe has been used for blood tests since the 19th century (at least). It is painful, and often terrifying for patients. It’s about time we had a better solution.

And this stuff is important. There’s already a test for HIV which requires just a pin-prick of blood, and which provides results within minutes. A study in the British Medical Journal on the effectiveness of this “rapid voluntary counselling and testing” (rapid VCT) concludes that:

“Rapid VCT in health facilities and communities was associated with a large increase in HIV-testing uptake and receipt of results.”

Being able to test a patient quickly, on the spot, without needing to stick a needle in their arm increases testing, diagnosis, and treatment. This is true whether dealing with lack of infrastructure in sub-Saharan Africa or acute needle-phobics in the US. In addition, a blood test in the US can cost hundreds of dollars. Theranos is offering tests for a little as $2.99.

Technology has overhauled basically every industry – retail, information, banking, entertainment, travel – except healthcare. Slowly, healthcare tech is starting to challenge traditional models, whether its telemedicine  or smartphone ultrasound machines. But it isn’t happening fast enough. Like millions of others, I loved the idea that a smart Silicon Valley startup could challenge the foundations of healthcare infrastructure with something as ubiquitous as a blood test.

And if it turns out Elizabeth Holmes couldn’t figure it out after all, somebody else has to. Progress cannot be allowed to stop here.

Rachel Cunliffe is Deputy Editor of CapX.