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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.
...before you get the idea that you need to start doing things properly?
Theranos really don't seem to be getting the hint that if they want to be taken seriously now they need to be utterly scrupulous about everything they do.
Paul Leader
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
I would say not much. Theranos was promising drug tests that would be significantly cheaper than current tests. According to Theranos pricing, Basic Metabolic Panel for about $6 bucks, Lithium level for $5... Together those might cost $200 (without insurance). I couldn't give two shits about who is at the helm if that's what they're promising.