On October 15 and 16, The Wall Street Journal published two front-page articles about Theranos. We have heard the questions that have followed these stories and want to provide answers.
As we provide these answers, it is important not to lose sight of a few simple truths:
Theranos’ technology is reviewed by regulators, proven in the field, and praised by leaders in the industry and doctors and individuals that we serve.
We provide blood tests faster, requiring far less blood and patient discomfort, than for any test previously available—or available today from any other laboratory.
We have run more than 3.5 million tests, with patient satisfaction scores from tens of thousands of patients that consistently rate Theranos, on average, over 4.8 out of 5. To our knowledge, we are the first laboratory to publish our prices, lab proficiency-testing scores, customer satisfaction scores, guest visit times, and more on our website.
We are confident in the reliability of our tests, because we comprehensively validate the accuracy of every test we run. In addition, we are the only laboratory that has committed to submitting all of our laboratory-developed tests, including our technology, procedures, and methods, to FDA for review and clearance. FDA has already cleared one of those tests, including our underlying test systems and Nanotainer™ tubes, for use in detecting the herpes simplex virus (HSV-1). The decision summary, which describes the rigorous science behind the clearance, is available online.
The faster speed and lower cost of our tests mean that consumers, and their doctors, can monitor their health so that problems are identified early enough to be addressed by medical professionals. That lower prices can reduce the cost to insurers, Medicare, and Medicaid by billions of dollars, and can give individuals access to critical health data they could not otherwise afford.
Our proprietary devices are making it possible to run finger-stick samples for tests that could never be run on finger-stick before. We began using our proprietary devices in our lab at the launch of our retail operations. And we initiated filings with FDA two years ago—by choice, not necessity—because we are seeking to create a new model for laboratory testing standards, and have championed FDA oversight ever since. It is the right thing, which is also the hard thing.
We are the same company offering the same services as we were last week.
Now, let us tell you what the reporter got wrong and why.