FDA Finds Flaws In Theranos' Zika Tests (techcrunch.com)

An anonymous reader quotes a report from TechCrunch: This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn't welcome to provide it yet is Theranos. The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports (Warning: may be paywalled). Specifically, regulators found that in developing and testing a new Zika-diagnostic technology, Theranos failed to use proper patient safety protocols, the type approved by an institutional review board. Such protocols are critical in ensuring the ethical treatment of patients involved in studies, and their safety. Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.

Comments

Girl Power!

[alternative_right]

How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?

How much actually focused on the product and the likelihood of it succeeding?

Our news today is more entertainment than fact.

Re:So there's nothing wrong with the diagnostic ..

[umafuckit]

... but the FDA is still finding something to complain about.

I can't see it say anywhere that the diagnostic test from Theranos works. It just says that there are problems with associated protocols. Seems like yet another example of their corner cutting behavior. Theranos doesn't exactly have a good history of producing reliable diagnostic tests.