FDA Extends Theranos Clearance To Include At-Home Testing

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Earlier this month, Silicon Valley-based lab test vendor Theranos gleefully announced that it has received FDA clearance of its entire testing process. The news was an important milestone for Theranos for several reasons, but the most important was that it provided independent confirmation that the tests Theranos offers are both safe and accurate. The company’s groundbreaking new testing method only require a finger stick rather than a venous blood draw, and processing the tests is both cheaper and faster than tests offered by hospitals or competitors like QuestLabs. The company, which was launched nearly a decade ago by a then 19-year old Stanford University dropout, has been firmly unwilling to provide detailed information on how its new way of performing lab tests works, leaving clinicians wary of trusting its results.

Theranos responded to a growing base of vocal skeptics by promising that it would voluntarily submit its entire testing process to the FDA for independent, but confidential, review. Currently, lab test vendors are not required to secure FDA approval before starting a business because tests must be ordered and interpreted by a physician, and the test must be carried out in certified labs. Theranos has been calling for a change to this policy, arguing for broad FDA oversight over lab testing vendors in hopes that by introducing FDA oversight, there would be enough confidence in the process to develop a broad, direct-to-consumer offering for its lab tests.

Now, Theranos has announced that it is one step closer to realizing its dream of building a decentralized lab testing platform. The FDA has updated the company’s clearance, authorizing it to administer its tests outside of a certified lab. Known as a CLIA waiver, this new authorization is traditionally issued to vendors whose testing process is so simple that there is little risk of error or erroneous results. Pregnancy tests, glucose monitoring tests, and many others have been cleared for at-home administration. Now, Theranos is free to offer its herpes simplex test in a similar format. This is the first herpes test to receive such a waiver. In practice, Theranos can now offer at-home test kits as well as on-site tests in retail environments, like the company’s growing number of wellness centers. Theranos CEO Elizabeth Holmes explains in the announcement, “Having the ability to make our test and system more broadly available in a variety of settings is critical to our aspirations to contribute to public health, as we continually innovate to provide the best laboratory testing services in the world. The ability for individuals and their health care providers to receive test results in near real-time will play a pivotal role in bettering diagnostic and treatment decisions.”


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