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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.

4 of 74 comments (clear)

  1. Girl Power! by alternative_right · · Score: 5, Insightful

    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.

    1. Re:Girl Power! by f97tosc · · Score: 3, Insightful

      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.

      Well at this point the primary story is the meta story about how otherwise sophisticated investors put in tons of money behind the the young, attractive, blonde woman even though they were shown very little evidence. That meta story is both entertaining and fact based.

  2. Re:How many times do you screw up... by Anonymous Coward · · Score: 3, Insightful

    How many times does a company like this need to screw up before being forcibly shut down by the feds?

    Embezzle a little money and they come in and lock the doors on any business you run. Endanger people's lives and you get a slap on the wrist. What's wrong with this picture?

    captcha = "boners"

  3. They are trying to run big pharm by Anonymous Coward · · Score: 2, Insightful

    These people are trying to run big pharm like it's a startup selling kitten mittens. Do it fast, get it to the market without proper testing and let our users beta test. It's all an internet scam, the only difference between Theranos and some other dot com blowout, is the government has more control over approval for medical treatments and devices.