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.'"
Awesome job, guys! (Score:5, Insightful)
I guess we can't all be disrupters...
Re:Awesome job, guys! (Score:4, Funny)
Re:Awesome job, guys! (Score:5, Interesting)
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
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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
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That's my feeling too. The whole thing smelled too much like a witch hunt.
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Sure, because nobody every put a medical device on the market that failed due to an unexpected task case, and/or were unable to produce documentation demonstrating that they did or did not have adequate test coverage
Re:Regulation; is there no harm it cannot bring? (Score:5, Informative)
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Yes, I am sure the laws of nature are conspiracy aimed at forcing big government on us and stifling or tech savvy dreams of flying out of the window by flapping our ears.
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Here come the fans of personal responsibility, blaming their failures on others...
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To me it seems like they continue to not quite live up to the hype. They have really interesting stuff that doesn't seem to be quite there yet. For medical testing I personally want them to be very rigorous making sure it works as accurately as what we have now. For non medical 'for funz' or 'other' testing I would be less concerned. I definitely want them to succeed as it would be a boon to the world, but it needs to be rock solid, not the 'mostly works' SV startup type stuff.
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How do they manage to get by with less material than is generally required, and have they been able to show (through data reproduction) that their techniques get the same results with less?
Re: Regulation; is there no harm it cannot bring? (Score:3)
I've read that they have at least one patent. They do not seem to be doing very well on the "reduction to practice" bit that is supposed to be a prerequisite for getting a patent, though.
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Shouldn't they have hundreds to thousands of patents if they're actually doing what they're saying?
Re: Regulation; is there no harm it cannot bring? (Score:2)
Thousands seems high. I could see dozens, and maybe hundreds in the US's patent-happy system. I don't know how many they have, beyond one that I saw attributed to their CEO's time in grad school. They might have dozens or hundreds (especially if you include filed but not granted).
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How do they manage to get by with less material than is generally required, and have they been able to show (through data reproduction) that their techniques get the same results with less?
So far as I know, they haven't let any independent labs near their technology. To me, an ex-med tech, that is extremely suspicious. If the technology is sound, they should be bragging about it, taking it to trade fairs and letting large hospitals test it out.
Re:Regulation; is there no harm it cannot bring? (Score:4, Insightful)
Even worse, a recent article indicated they had effectively stopped using their own process for testing and had gone back to using the previous method.
If anything screams scam, that should be a flashing red light.
Re: Regulation; is there no harm it cannot bring? (Score:4, Informative)
Why do you say they are technically savvy? Their marketing appears to be savvy, but all the impartial stories I've seen (including from Reason, which is usually against regulators and incumbents who benefit from regulations) give the impression of dodgy technology at Theranos.
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Theranos has made unsubstantiated claims from day one, and tried everything they can think of to bypass the process every other medical device manufacturer follows.
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A capillary blood collection tube is Class I and not subject to pre-market approval (21 CFR 864.6150). But for some reason the Theranos capillary nanotube is class II? Why?
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Theranos device has integrated testing capability and the capillary tube contains the sample while it is delivered to a desperate testing device, which in all likelihood is a medical device
Response is simply common sense (Score:1)
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
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Are you really advocating a system where patients regularly give multiple samples and send them to multiple labs just to check to see if the lab isn't cutting corners at the risk of killing them? We have a regulatory agency to prevent that sort of thing (rather than waiting until after the bodies stack up). In this case it's called the FDA.
Except that the FDA is doing much much more than that. If the FDA merely had a certification program that allowed patients to know which labs were more likely to give accurate results - then that would be very useful.
But the FDA is not allowing people to choose: it is forcing them to only use certified labs. And there are compelling reasons to suspect that the certification process is less about insuring accurate results and more about protecting existing monopolies (e.g. forcing people to pay medical docto
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I'm not advocated for that. I'm saying people will do that anyway, and if results are inconclusive they will let people know.
People are just like that in case you hadn't yet figured it out.
Re:Response is simply common sense (Score:5, Informative)
"Are you so sure? Does it not make some sense that advancements could be made on how much you need to collect?"
On this point, yes, we're pretty sure.
Here's the problem: when there's something bad (bacteria, virus, mutated DNA) in your system, it usually appears in very small copy numbers (copy number is a technical term that tells you how many copies of something you see in a given sample). The relative abundance (another commonly used term that tells you how common your target is compared to everything else in the sample) of the bad stuff (not a technical term) is usually very small compared to the good stuff. So much so, that often times you need a large sample just to get a single copy of a bad thing. In most biological systems, we're talking needle-in-a-haystack small copy numbers for bad things.
Think of it this way: Let's say you have a gallon bucket full of coins with only a few quarters. You randomly sample a cup of coins. Can you confidently say there are no quarters in the bucket? Now say the coins are flowing through a series of tubes (no, these are not bitcoins on the internet) and your sample is determined by the coins present when you siphon off your cup's worth. What would the relative abundance need to be before you can confidently say quarters are present in the system using a cup for sampling? How about using a quart for sampling?
Somewhat like the laws of thermodynamics limit the ability to create perpetual motion machines, relative abundance/copy number place hard limits on the sample sizes needed to detect things in blood with confidence.
-Chris
Re:Response is simply common sense (Score:4, Interesting)
Single cell sequencing isn't useful as a diagnostic technique for the same reason I outlined above: every cell has a slightly different genome sequence.
When you're sequencing for diagnostics, you need a consensus genome for the tissue or tumor, not the genome for individual cell in the tissue or tumor. That's because not every cell in the tumor will necessarily have the variation that led to the tumors and it's possible for a single tumor cell to be in the healthy tissue. It's only over populations of cells that the negative effects can be measured properly.
If you're measure gene expression instead of DNA variants (e.g., looking for gene fusions), the problem is even worse. Not only do you need to sample many cells, but some of those cells need to be actively expressing the damaged gene to be able to sequencing it.
Disclaimer: I helped develop a single cell sequencing product and currently run a gene sequencing software company. I'm also friends with people at the FDA. I can assure you, they're not protecting profits for anyone and have the best interests of the patients in mind. It might look like bureaucratic overreach at times, but their goal is for only safe products enter the marketplace.
That goes for interpretation, too, which is why 23andMe got smacked down so hard. The science connecting genotypes to phenotypes is not as strong as the popular press would have you believe (there's currently a reproducibility crisis in the whole genome association study (WGAS) community, where most of the disease/gene associations come from). Sure, you can go to pub med and read all the studies, but understanding the body of knowledge to place those studies in context is difficult even for professionals.
-Chris
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And by WGAS, I meant GWAS (genome-wide association study). Post-workday brain kicking in...
-Chris
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23 and Me was warned that their changes in advertising were pushing the limits, and they changed them again to push the limits further.
What specific claims were they making that were so objectionable that you think it was necessary to take away their freedom of speech? Do you imagine that the American public is so stupid that they can't tell the difference between a website and a medical doctor?
Then the government said "Okay, back up what you're saying." Which was met with silence.
The variant calls that 23andMe was providing were from a CLIA-certified lab. So the underlying data was as good as what you would get from a test ordered through a medical doctor.
The question was the interpretation. And the FDA made the assumption t
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You're posting as an AC, so it's not really worth responding, but...
Please give me some citations to support your claims that millions are dying due to the FDA holding back innovative treatments.
While you're at it, give me some citations that show that the average American can properly interpret the result of self-prescribed tests and make sound medical decisions on their own without the advice of experts.
For the first, cancer is the genomic disease that kills the most people. There are roughly 600k cancer
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I don't have the citations where I can get at them anymore, but it's relatively common knowledge in the drug development community that there's a lot of relatively strong candidates that die in development for no other reason than the money required to push them through the FDA tests, meaning that while I agree that the science of genomics is in its infancy, I'm not quite comfortable betting that we might not end up in the very awkward position of simultaneously having genomics being well-accepted in the sc
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The current inquiries are into Theranos' lab services arm, which is already up and running and (mostly not using their own process to do so) offering various blood tests. For the process that they are researching, efficacy is between them and their investo
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Actually, we're not. I'm pretty high up in finance in the California division of the largest testing company. I don't speak for my company so I'm posting as AC.
It's an interesting situation. We're taking a wait-and-see approach to what Theranos is doing. This is a very highly regulated business, and Theranos' approach was backwards-- they set up their
More corporate welfare... (Score:1)
gone wrong.
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US Space Program
Previous articles on Theranos (Score:2)
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]
it's not a story about blood (Score:5, Insightful)
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.
Re:it's not a story about blood (Score:4, Funny)
Between that description and the name 'Theranos', this sounds like the backstory for the next version of an upcoming post-apocalyptic FPS.
Re:it's not a story about blood (Score:5, Interesting)
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.
This company ticks all the checkboxes. (Score:2)