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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.'"
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
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.
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