If there were a category for biggest loser on MD+DI’s annual list of winners and losers, California startup Theranos would likely take the dubious distinction.
The Palo Alto company, whose much-vaunted young CEO Elizabeth Holmes aimed to upend the laboratory testing world with its finger prick technology, saw itself biting the dust after a brutal expose in the Wall Street Journal in October.
The technology, as it turns out, is not accurate, allege former employees. Further, Theranos is using conventional lab testing machines and traditional blood draws for the majority of its test for consumers. The article also accused the company of covering up data that showed that its test results differed materially from those using standard blood-testing equipment.
To add insult to injury, an FDA inspection of Theranos found that its Nanotainer—a blood-collection device—is an unapproved medical device. FDA informed the startup valued at $9 billion that it has poor quality management and inadequate processes to handle customer complaints.
Walgreens, with which Theranos has partnerships, decided not to open more Theranos blood-testing centers. Under fire and in a bid to quiet skeptics, Holmes has promised to publish its data for peer review.
|Start 2016 off right by attending MD&M West, the world's largest medical design and manufacturing event, February 9-11, at the Anaheim Convention Center.|