Theranos Gets FDA Approval For Its Secretive Lab Test Process

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Theranos, Silicon Valley’s billion dollar blood-testing startup, announces that it has secured FDA clearance for its herpes simplex test, a process that it voluntarily undertook to assure the public that its innovative new blood analysis method is as accurate as the traditional process it hopes to replace.

Theranos was founded in 2003 by Elizabeth Holmes, a 19-year-old Stanford University dropout that now holds the honor of being the youngest entry on the Forbes billionaire list, with an estimated net worth of $4.5 billion. Under the leadership of Holmes, Theranos brought an innovative new blood-testing methodology to market that can run multiple tests from a single finger prick blood sample, and can do so faster and cheaper than current technologies are able to. The technology behind Theranos, if it proves to be a cheaper, faster, and equally accurate solution, could revolutionize the clinical laboratory market globally.

The pervasive problem for Theranos thus far is that clinicians are uncomfortable using the company’s tests when they do not understand how they work, or if the results they produce are as accurate and reliable as traditional lab analyzers. The journal Clinical Chemistry and Laboratory Medicine recently published an editorial calling the company’s claims “exaggerated.” Jerry Yeo, PhD and director of Clinical Chemistry Laboratories at the University of Chicago, reiterates those sentiments in a recent Business Insider interview: "They completely bypassed the traditional process of peer review or publishing in peer-reviewed journals or having peer labs evaluate their product." To date, Theranos has not publically published any information comparing the accuracy of its tests to that of traditional tests, or explaining in detail how the tests actually work. Holmes has defended her decisions by explaining that the way her company’s tests work is valuable and proprietary information, and that since the FDA is the “gold standard” of independent evaluations in the medical field, she would lobby to have them assess the accuracy and reliability of her tests.

Now, Theranos is happily reporting that the FDA has evaluated its testing procedures from end-to-end and has approved its method. The company is still not willing to provide a detailed explanation of its testing process, but hopes that its newly-earned FDA approval will calm the concerns of the clinical community that it hopes to win over and sign on as customers.


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