Theranos’ mission is to make actionable information accessible for every person at the time it matters most. Our work is about building a healthcare system in which early detection and prevention become reality; a world in which people are able to determine the onset of disease in time for treatment to be effective. Our model is about transparency and accessibility. We list our prices – always a small fraction of Medicare reimbursement rates and the same for everyone irrespective of insurance coverage – so that individuals and physicians know in advance what a test will cost. And we provide individuals with testing that is designed to be faster, cheaper, and less painful at the highest levels of quality. Our mission depends upon meeting the highest standards of test quality – standards set by the Food and Drug Administration (FDA). That is why this week, Theranos supported the FDA in their proposed framework for the regulation of laboratory tests that have been developed “in house” by certified laboratories. We support this effort because we know from our own experience that FDA standards are the gold standards for laboratory tests that so many individuals rely on in making important decisions about their health.
Theranos is submitting and will continue to submit all our tests to the FDA. We are not required to do so, but we have made this commitment because we believe that FDA oversight plays a critical role in ensuring that individuals and their physicians get the most accurate test results. FDA clearance or approval serves as the highest bar of validation in this country and around the world. While there are limits on the adequacy of the peer review system – limits that the FDA has noted, including that “the published literature do not always contain a complete, or entirely accurate, representation of the device design, performance, manufacture, clinical study plans, conduct, accountability, and outcomes”1 – we know from firsthand experience that meeting the standards required for FDA review ensures the analytical and clinical validity of a test more than any other standard. That is why we will continue to submit our work to the FDA and why we believe the decision to do so is essential in providing accurate results for individuals and physicians.
The full text of Theranos’ Comment to FDA can be found here
1 Guidance for Industry, Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review, http://www.fda.gov/RegulatoryInformation/Guidances/ucm080183.htm.