Early this morning, the Wall Street Journal published an investigative report that said former Theranos employees claimed the company was not using their own new "revolutionary" blood tests for the majority of lab testing, largely because of concerns about accuracy.
In response, the company says that the Journal relied on sources who were not in a position to know whether the tests were accurate or not, and called the doubts about accuracy "baseless" and "erroneous."
Here's Theranos' response in full:
Today’s Wall Street Journal story about Theranos is factually and scientifically erroneous and grounded in baseless assertions by inexperienced and disgruntled former employees and industry incumbents. Theranos presented the facts to this reporter to prove the accuracy and reliability of its tests and to directly refute these false allegations, including through over 1,000 pages of statements and documents. Disappointingly, the Journal chose to publish this article without even mentioning the facts Theranos shared that disproved the many falsehoods in the article.
Theranos’ products and services have proven accurate and reliable for tens of thousands of satisfied customers through millions of tests and experiences and in ongoing review by our various regulators. Our focus remains ensuring high quality real-time, actionable information to improve diagnosis and treatment decisions. When you create innovative technology, scrutiny is to be expected. We have always welcomed that scrutiny – opening up to regulators like no lab before and voluntarily submitting all our tests for FDA review, the gold-standard for quality. We received our first FDA clearance this summer based on the very proprietary systems the story is asserting don’t work, and have submitted almost 130 pre-submissions at FDA for tests run on those proprietary systems.
Theranos is working to reinvent the lab experience by providing high quality tests faster, cheaper, and more conveniently, requiring less blood, and causing less patient discomfort than ever before. We lead the industry in transparency and quality, have advocated for FDA regulation of lab tests, for the reduction of Medicare and Medicaid rates, and for transparency in pricing. We’ve partnered with health care leaders including the Cleveland Clinic, Capital BlueCross and AmeriHealth Caritas. We also have advocated for direct access to lab testing, which will drive price transparency and lower the cost of testing in response to consumer demand; this issue is at the heart of the current movement towards individual engagement and preventive health care.
The sources relied on in the article today were never in a position to understand Theranos’ technology and know nothing about the processes currently employed by the company. We are disappointed that, in an effort to make its story more dramatic, this reporter relied only on the views of four “anonymous” disgruntled former employees, competitors and their allies, instead of reaching out to many of the scientific, health care and business leaders who have actually seen, tested, used and examined our breakthrough technologies. The Journal even declined an opportunity to experience the technology themselves by turning down our offer to send proprietary Theranos devices to their offices so they could have a demonstration of tests conducted themselves, and compare the results to those of other testing providers.
Stories like this come along when you threaten to change things, seeded by entrenched interests that will do anything to prevent change, but in the end nothing will deter us from making our tests the best and of the highest integrity for the people we serve, and continuing to fight for transformative change in health care.
