Was Edison's "one drop of blood" technology abandoned prematurely due to regulatory pressure? Is the concept still viable with more development? How much is known about miniLab's capabilities and performance? How much of an advancement does it represent?
To be resolved: Did Edison do what Testing claimed it
"Theranos's Edison technology is not worth further consideration — except as it sheds light on questions of the company's truthfulness with investors, potential investors, and retail and HMO partners. The company has acknowledged that the device had limited application and accuracy, and has abandoned it.
Its current project, the miniLab and associated technology, has become the company's full focus. It is still in development and too early to say what its impact and opportunity will be. This statement, displayed prominently on the Technology pages of Theranos's website, sums it up: 'This technology has not been cleared or approved by the FDA and is not for sale in the United States.'
Early reviews by the scientific community were lukewarm. The American Association for Clinical Chemistry got the first look at a miniLab prototype in August, 2016 during a 55-minute slideshow presented by CEO Holmes. One attendee's assessment, that of Jerry Yeo, director of the University of Chicago's clinical chemistry laboratories: 'There was nothing revolutionary or disruptive behind the technology of the miniLab.' He also said it must be tested by independent labs and written up in peer-reviewed journals before any conclusion can be drawn." *Assigned Advocate. If a party does not provide a statement, the Moderator may assign an advocate from the PeopleClaim online mediation community to represent their side of the case.
Theranos has acknowledged regulators' concerns with its earlier technology (i.e., "Edison"), assessed the situation, and concluded that company energies are better spent developing new technology.
Current Theranos technology encompasses a lab testing framework with three core stages: 1) a finger-stick blood collection and storage device that makes it easier and less painful to collect blood samples; 2) the Theranos miniLab, a portable device designed to process and analyze very small samples of blood. (It amounts to a huge diagnostics lab condensed to the size of a microwave.); and 3) the Theranos Virtual Analyzer (TVA), a remote server that is designed to communicate with the Theranos miniLab through secure wired or wireless connections. The TVA will analyze all raw data that is sent from the Theranos miniLab, and measure the miniLabs' performance metrics to ensure that each device passes strict quality control measures.
Though still in development and not yet approved by the FDA, miniLab is a step forward and a significant technological achievement. The miniLab incorporates many important inventions, including the miniaturization of different kinds of diagnostic tests, managed with robotic assistance, and capable of being orchestrated at one time within a small miniLab housing. This will result in easy-to-distribute testing stations to bring rapid diagnostics to more places at a lower cost.
*Assigned Advocate. If a party does not provide a statement, the Moderator may assign an advocate from the PeopleClaim online mediation community to represent their side of the case.