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Theranos faces scrutiny over medical device claims [Video]

Following several months of questions and criticism over the company’s promised blood testing machine, Theranos has unveiled a new high tech medical device. The miniLab was showcased to a group of laboratory scientists at this year’s annual meeting of the American Association for Clinical Chemistry.

Theranos founder Elizabeth Holmes says the device can run blood tests on as little as 160 microliters of blood, or a few drops, pricked from a finger. If true, this could revolutionize medical testing, making testing for blood-borne diseases as simple as checking glucose levels.

“We’re pleased to share our technologies with the entire laboratory industry,” Holmes wrote in press release issued alongside her remarks to the AACC. “It’s the beginning of the next phase of the company, as we introduce our technologies to the world.”

This new product is the successor to the controversial Edison machines that got Theranos in hot water in the past. When the company first went public, critics pointed out that the company had not made its analysis framework sufficiently transparent to prove some of the major promises related to its devices. This brought additional scrutiny, resulting in Federal regulators investigating the company’s Newark lab, declaring it a threat to public safety

Holmes has also faced a Congressional inquiry over her lab practices and was recently banned from operating in her own labs, causing Theranos’ value to fall from $9 billion to just under $800 million. A source also told the Wall Street Journal that claims related to the miniLab only needing 160 microliters of blood to perform the promised 11 blood tests are unrealistic, potentially requiring more than a single sample. 

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