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US Regulators Find Serious Deficiencies At Theranos Lab (wsj.com)
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.'"
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...
Now society has to wait a decade while vastly more blood is drawn than is really needed for tests, because even a single drop of blood being outside the body is too fearsome a prospect to bear for the wilting Nanny State.
I'd say there's a better than even chance some large testing companies have put the fix in to make sure this technically savvy startup gets shut down.
"There is more worth loving than we have strength to love." - Brian Jay Stanley
gone wrong.
FYI: Theranos has quite a controversial background of articles here at Slashdot:
In October, they were called "vaporware."
In November, they were "disruptive."
In December, they had alleged data manipulation.
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.
it should up to the free market to decide what punishment to mete out,
It is, if enough people get second opinion tests and it's shown the testing is flawed, people will not use them...
Yet a lot of people do continue to use them.
The nanoliter concept has serious issues - some things you need more than a microliter of possibly contaminated blood to test for.
Are you so sure? Does it not make some sense that advancements could be made on how much you need to collect?
Oh but wait, let's just blame Obama. That's easier.
Who said anything about Obama? This is a vastly larger issue, as the FDA is obviously being paid by existing testing companies to eliminate a potential threat. Let's see if the company can make the process work before bringing in government goons to shut it down beforehand.
"There is more worth loving than we have strength to love." - Brian Jay Stanley
the ceo is so pretty, how could she be evil ;^)
With all the statements I have seen fall out of this individuals mouth
"if you have a plan "b" you have allready lost."
Or something to that effect..
I think the chip on her shoulder may have caused some blindness.
Regardles man or woman, any insensitive statements like the arrogant one above should be a negative indicator .
I beleive the same thing about her feminine colleges Carly and or Meg with reference to the buying of Sacramento California.
But, moving ahead, I feel bad for the individuals whom have been or are being falsely led by this individual..
I am sure if this individual was no so publically outspoken about being a successful "female CEO" I bet this (like others) would have not gotten so much attention..
"living in the lime light, the universal dream"
Stupid fuckfaces from Silicon Valley think that laws and regulations to apply to them. Medical devices are regulated for a reason and that is to stop snake oil salesmen from selling devices etc that simply don't work, put a patient in danger, etc etc.
They are doing the same model as Uber, fuck the regulations, we're ABOVE THE LAW!
In short, there ain't no such thing as a free lunch.
The better way to look at it would be to get the corrupt bureaucracy out of everything we touch. Oh I know.. blah blah but the Government needs to regulate everything.. BULL! Before you jump on your time tricycle remember that Snake Oil selling is ALREADY ILLEGAL. If you die from taking it, person selling goes to jail for murder. If it does nothing, then there is fraud. Problems with industry stagnation are directly related to the corruption which can happen due to massive Government encapsulation of "Medical". The same problems we have with Insurance..
I'm not a pure anarchist, but I have read some great works. Buy some Stephan Molynoux, he's a good start and very thorough.
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 leaders might spend more time on something else. A full time self promotion tour has only one real goal, self promotion. Actually working on a product of this nature takes huge amounts of effort in the lab, and then huge amounts of effort in the regulatory department. There is no time left for strutting and preening. This is what marketing departments are for.
/., reddit, local newspapers, international news, everywhere at once. Again this only happens when the product is something for everyone (erection drugs) or has a massive promotion campaign behind it. Except that, again, this product only needs to be promoted to labs, and it pretty much will sell itself if it works.
The other reality is that a product like this can pretty much sell itself. But my first indication of the product being crap was that I was suddenly seeing it mentioned everywhere. Here on
Thus all that promotion was aimed at investors. She was aimed at investors. This entire exercise was a combination of promoting her, and getting investor money into her pocket. Full stop. The science would pretty much have gotten in the way. Plus I can see someone like her actually resenting a star scientist who might actually end up with credit. I suspect that the scientists working for her were glorified coffee boys and pencil sharpeners.