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

Posted by samzenpus on from the worst-practices dept.

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.'"

6 of 66 comments (clear)

  1. Awesome job, guys! by fuzzyfuzzyfungus · · Score: 4, Insightful

    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...

    1. Re:Awesome job, guys! by Anonymous Coward · · 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

  2. Re:Regulation; is there no harm it cannot bring? by Software · · Score: 4, Informative

    Theranos has been making extraordinary claims and providing no proof (to the public, anyway).

  3. it's not a story about blood by supernova87a · · Score: 5, Insightful

    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.

    1. Re:it's not a story about blood by N7DR · · Score: 4, 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.
       

  4. Re:Response is simply common sense by rockmuelle · · Score: 4, 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