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US Regulators Find Serious Deficiencies At Theranos Lab (wsj.com) 66

An anonymous reader writes: 2016 has not started well for blood-testing startup Theranos. Already facing allegations of data manipulation, the Centers for Medicare and Medicaid Services have found problems with Theranos' laboratory in Newark, California, putting the company's relationship with the Medicare program in danger. WSJ reports: "It isn't clear exactly what regulators have faulted Theranos for in their latest inspection, which took several months. Adverse findings would be another regulatory setback for one of Silicon Valley's highest-profile startups, valued at about $9 billion in 2014. Theranos already has stopped collecting tiny samples of blood from patients' fingers for all but one of its tests while it waits for the Food and Drug Administration to review the company's applications for wider use of the proprietary vials called 'nanotainers.' In October, the FDA said it had determined that the nanotainers were an 'uncleared medical device.'"
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US Regulators Find Serious Deficiencies At Theranos Lab

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  • Awesome job, guys! (Score:5, Insightful)

    by fuzzyfuzzyfungus ( 1223518 ) on Monday January 25, 2016 @05:00PM (#51368891) Journal
    So, going from a revolutionary plan to do tests with markedly less blood using your super-neat proprietary hardware to not even being able to operate off-the-shelf hardware from competitors well enough to satisfy Medicare?

    I guess we can't all be disrupters...
    • by 110010001000 ( 697113 ) on Monday January 25, 2016 @05:15PM (#51369021) Homepage Journal
      Guys? The CEO is a woman. Don't be sexist.
    • by Anonymous Coward on Monday January 25, 2016 @05:19PM (#51369043)

      Nothing easy about it

      I led a team that developed a shipping/receiving system for the collection of tissue.
      At the time that we did the work the direction from the FDA led us to believe that it would not be a medical device
      18 months later, when they saw out spiffy new system in the field, they questioned why we did not apply to have it released as a medical device...

      This became a 'Big Deal' as the FDA threatened to recall about three months of product ($50 - $70 million in value) if we could not demonstrate complete traceability through the system with clear reporting of every sample

      Fortunately we designed every piece of the system as if it were a med device and came through the audit with flying colors

      Unfortunately the company that I worked for would not submit the system for formal review as a medical device and we pulled it out of service.

      Understanding the FDA requirements for a medical device, and staying in touch with them throughout your development process to make certain that they have not changed their direction is essential to staying alive in that market space

      • Figuring out where you are in the FDA regulated world can be difficult, but Theranos isn't in that situation. Diagnostic manufacturers and diagnostic labs go through FDA clearance. No ambiguity there (ok, LDTs are ambiguous, but that loophole is closing).

        Theranos knew this, and successfully went through FDA with a herpes diagnostic, as well as being qualified as a diagnostic lab. Given all that regulatory engagement, it boggles the mind that they didn't see this coming. Either they didn't know they were

  • by Anonymous Coward

    gone wrong.

  • FYI: Theranos has quite a controversial background of articles here at Slashdot:

    In October, they were called "vaporware." [slashdot.org]
    In November, they were "disruptive." [slashdot.org]
    In December, they had alleged data manipulation. [slashdot.org]

  • by supernova87a ( 532540 ) <kepler1@hotmai l . c om> on Monday January 25, 2016 @05:44PM (#51369239)
    The real story here is not about some medical device or a failed test.

    The story, and reason we take pleasure in this downfall is because a charismatic, supposed prodigy, Stanford-privileged, everyone-wants-to-believe-in-successful-woman CEO, who was able to convince funders based on flashy visions and compelling talk, has been found out to have nothing behind the emperor's clothes. And that so many people who are purportedly expert at evaluating technology got collectively duped/brainwashed into believing a whole bunch of fluff based on no more than a TED talk-level technology pitch.

    While others who are working on real demonstrable technology, and do not get the benefit of celebrity status, Silicon Valley connections, get passed over for grants / VC money / recognition because they're not connected or privileged in the same way.

    Stop believing so much in the vision and hype. Ask for and act on real results more.
    • by Krishnoid ( 984597 ) on Monday January 25, 2016 @05:51PM (#51369293) Journal

      Between that description and the name 'Theranos', this sounds like the backstory for the next version of an upcoming post-apocalyptic FPS.

    • by N7DR ( 536428 ) on Monday January 25, 2016 @06:52PM (#51369743) Homepage

      And that so many people who are purportedly expert at evaluating technology got collectively duped/brainwashed into believing a whole bunch of fluff based on no more than a TED talk-level technology pitch.

      I am frequently amazed at how willing VCs tend to be to provide money while at the same time being unwilling to express skepticism, even to themselves, about the claims of some of the companies they fund.

      Some time ago, after a particular VC firm had dumped $40m into a "security" (for which read "snake-oil") company, the company suits happened to make a closed-door presentation which, unknown to them, a handful of people with practical security expertise had been invited to attend. A VC representative was also in attendance, although he did not speak. When we recommended, after the talk, that the listeners have nothing further to do with the company product, the VC representative sought one of us out (it happened to be me) and the end result was that I spent a day at the company facility, towards the end of which I had a short meeting with the VC representative and explained at an intelligent layman's level why the product could never work. The money pipe closed that day. But I remain puzzled as to how $40m could have been dumped into a scheme that was so obviously flawed.
       

  • How many times will investors be fooled by people like this. When I see a company that has a "superstar" on the front page of everything, giving talks, giving interviews, always in the "top 40 under 40" I just know that this is someone who is not minding the store. If you look at companies that were massive successes in their start such as Google, Facebook, Microsoft. These were companies where the top people largely stayed out of the spotlight. Later after the companies had massive and real products the le

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