CEO SUMMARY: Following months of investigation, reporter John Carreyrou of The Wall Street Journal published back-to-back reports about aspects of Theranos that the secretive company has kept from public view. Based on interviews with several employees and others with knowledge of events at Theranos, the WSJ disclosed that Theranos runs only a handful of tests
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A nanotainer is the proprietary name for a tiny vial, less than half an inch tall, intended to hold a few drops of blood as part of the self-described “disruptive” blood testing technology invented by Theranos.
Theranos claimed that its proprietary technology allows it to run as many as 200 blood tests on just a couple of drops of blood, drawn via finger prick instead of a needle, that are contained in the Nanotainer.
However, when the federal Food and Drug Administration conducted unannounced inspections of Theranos facilities in August and September 2015, it reported that the nanotainer is a Class II Medical Device, for which manufacturers must use special labels, meet performance standards, and conduct post-market surveillance. FDA noted that Theranos was using the device without its clearance or approval.
Theranos argued that the nanotainer is a Class I device, for which there are no regulatory requirements However, the FDA documented a number of complaints from its inspections, including that a the Nanotainer had a design evaluation that didn’t ensure the device “conforms to defined user needs and intended uses.” Additionally, the nanotainer “was not validated under actual or simulated use conditions,” and the risk analysis for the device hasn’t been adequately documented. FDA also said there were inadequate procedures for logging customer complaints, and that complaints that Theranos’ technology didn’t work weren’t reviewed or investigated.
Theranos had become involved in legal proceedings in 2014 following objections filed to Theranos’ trademark application by Becton Dickinson, which holds a trademark for the name “Microtainer.”
Theranos responded by filing papers asking that the U.S. District Court for the Northern District of California rule that “nanotainer” does not infringe the “microtainer” trademark used by Becton Dickinson. The parties arbitrated and settled their dispute on Sept. 28, 2015 with apparently no money changing hands.
However, in October 2015, Theranos founder Elizabeth Holmes announced that the company was no longer using the nanotainer except for one FDA-cleared test, HSV-1, for which it earned FDA clearance in July. For more than 240 other blood tests, she said, Theranos was performing traditional venipunctures with test tubes and standard analysis technology.
As of late 2015, Theranos had released no data or peer-reviewed studies to prove its claims for the nanotainer or its blood analysis technology. After becoming the target of a major expose by the Wall Street Journal,, CMS sanctions and numerous lawsuits in 2016, the company announced that it was leaving the clinical lab business to focus on device development instead.
CEO SUMMARY: Winston Churchill famously said that “Russia is a riddle wrapped in a mystery inside an enigma.” That description could apply to Theranos, the company that claims it is poised to disrupt the entire clinical laboratory testing industry. In Phoenix, where Theranos is ramping up its clinical lab marketing and operations, competing lab companies have it under the microscope. Some say not all may be going to plan and Theranos has been asked to comment on several issues.
BY FILING A LAWSUIT IN FEDERAL COURT against Becton Dickinson, Theranos, the ultra-secretive lab testing company based in Palo Alto, California, has once again put itself in the headlines.
CEO SUMMARY: With each passing month, Theranos pulls open the curtain a bit more on its business structure and its market growth plans. Its clinical lab tests are now offered in Walgreens pharmacies in Palo Alto, California, and Phoenix, Arizona. Recent news coverage in Fortune and USAToday disclosed that company officials—based on stock sales to
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, it has provided no information about the science that supports this testing and the clinical validations