Theranos blood tests often wildly wrong and may be shut down by feds

Founder and CEO of Theranos, Elizabeth Holmes at TEDMED 2014. (credit: https://www.youtube.com/watch?v=dBvzKp0AERE)

Late Thursday, federal regulators released a redacted 121-page inspection report of a Newark, California Theranos facility, which revealed that the company’s high-profile finger-prick blood tests failed quality control checks nearly 30 percent of the time.

Theranos and its CEO, Elizabeth Holmes, made waves last year with claims that they could carry out more than 200 medical tests with their Edison devices using just a few drops of blood from a finger prick—rather than a full vein draw taken by a needle. With promises that the cheap and easy finger-prick tests could revolutionize medical diagnostics, the company was valued at $9 billion.

However, since the initial buzz, the company has been hit with a series of questions, criticisms, and federal regulatory snags surrounding the accuracy and validity of its tests. In the latest setback, the Centers for Medicare and Medicaid Services (CMS) released a redacted inspection report that seems to substantiate concerns and whistleblower reports of the Edison’s failings.