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The Tech World's Blood-Test Darling Theranos Makes Giant Stride Forward

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The Silicon Valley company Theranos has an alternative—instead of a hypodermic needle and multiple vials of blood, Theranos technology uses a finger prick like the one diabetics use to measure their blood sugar. With just a few milliliters of blood Theranos can test for hundreds of things, from cancer biomarkers to cholesterol counts, illegal drugs to infectious diseases. What’s more, many of the tests are cheap. And in at least one state, the system doesn’t require a visit to a doctor’s office or a lab. But Theranos has been slow to deploy its system. 

Now things are starting to pick up. On Thursday the US Department of Health and Human Services gave the company a Clinical Laboratory Improvement Amendments waiver1 for a single finger-prick blood test, for type 1 herpes simplex. But that CLIA waiver does much more than approve one test—it also covers Theranos’ complete system, hardware and software underpinning the entire diagnostic suite. That means that Theranos’ partners, places like Capital BlueCrossAmerihealth Caritas, and the Cleveland Clinic, can install Theranos tech in place instead of having to send samples back to the company’s Silicon Valley headquarters for testing.

And earlier in July, the FDA declared that same finger-prick herpes test was just as effective as the current version, the one with needles. Then Arizona made it legal to get a blood test without a doctor’s permission, on your own initiative.

Taken together, these developments mean Theranos is on its way to reinventing the field of clinical chemistry—that’s blood work. And that has some scientists worried. While Theranos has touted the fact that the FDA says its tests work as well as traditional diagnostics, the company hasn’t been forthcoming about how the tests work. So physicians are asking if it’s enough for Theranos to be cheaper and faster when they don’t know—can’t know—how the company gets its results.

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