At the American Association for Clinical Chemistry (AACC) conference this week, Theranos CEO and founder Elizabeth Holmes unveiled the details of a new blood testing device, called the miniLab. The device was designed to analyze small-volume blood samples using multiple different diagnostic methods in a single desktop machine.
The device is not yet approved by the US Food and Drug Administration (FDA), however Holmes presented data based on the device’s ability to analyze capillary blood samples at the AACC conference. Holmes recently received a two-year ban from owning and operating a blood testing business from US regulators, after violations were identified at t
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While Theranos’ Edison device was touted as a revolutionary tool with the potential to diagnose multiple conditions from a single drop of blood, the company has since fallen from grace. An inspection of the company’s California testing facility last year – conducted by the Centers for Medicare and Medicaid Services (CMS) – highlighted a number of issues with Theranos’ blood testing practices.
In an effort to find a solution to those concerns, Theranos voided tens of thousands of blood test results which were released between 2014 and 2015. Despite their efforts to make amends, the CMS banned Holmes from the medical laboratory business for two years, and the Newark lab’s certification was revoked.
With Holmes’ impending ban set to take effect on September 5, some had expected her to speak about the validity of the Edison device at the AACC conference. Instead, Holmes discussed the company’s newest miniLab device.
“We’re pleased to share our technologies with the entire laboratory industry,” said Holmes. “It’s the beginning of the next phase of the company, as we introduce our technologies to the world. We also will be working with academic institutions and other independent parties to validate and publish our results.”
Holmes has since faced additional criticism for failing to speak to the inefficiencies in Theranos’ current blood testing methodologies. She has also not provided any peer-reviewed studies on neither the Edison nor the miniLab device.