Can someone help me on the technical aspects of the blood tests they've developed?
The premise appears to be that they take extremely small samples ("25 to 50 microliters") and run lots of tests ("as many as 70 different tests from a single draw") using "the same fundamental chemical methods".
This compares with standard blood tests which require 2 orders of magnitude more blood ("numerous tubes of blood, each containing 3,000- to 5,000-microliter samples").
How does one produce reliable output with the same sensitivity/specificity using the same chemistry with so much less blood? I find it hard to believe that the existing lab procedures left that much efficiency on the table...
Can someone help me on the technical aspects of the blood tests they've developed?
On the specifics, I'm afraid nobody can for now. They have refused to peer-review their protocols and validation data, so their assays are essentially a black box. So far, incredibly, they have managed to get away with this thanks to a glaring regulatory loophole (as the article explains); but sooner or later they'll have to open up if they want their assays to be taken seriously by the medical community.
In broader terms, however, there's been a lot of recent work in the well-established microfluidics [1] literature on whole-blood assays [2], so that can give you a good guess about how they go about their implementation: most likely some form of "lab-on-a-disk" centrifugation for plasma separation and subsequent transport to separate microfluidic optical chambers preloaded with colorimetric reagents for readout, using perhaps a digital camera and some non-kosher/black-boxy form of curve-fitting DSP to increase "sensitivity".
In all I'm very skeptical until they open up and provide peer-reviewed validation data for their assays. There are already several companies doing patented blood microfluidics like Abaxis [3] with peer-reviewed validation, and the enabling technologies have been out in the open in the literature for years, if not decades; so the whole "we are doing a super duper secret awesome thing we can't tell you anything about" sounds rather D-Wavey and fishy to me.
It's not fishy, it's just a business strategy rather than a tech strategy.
They have a couple microfluidics assays that are profitable and they suspect these might be patent encumbered (even beyond the troll that they have already brought into the fold by giving him a board position.). Secrecy buys them two things:
1. Their competitors won't know what their loss leaders are. If assays A,B, and C have been optimized to profitability but D and E are still loss leaders, a competitor could use that knowledge by subsidizing demand for D and E (e.g. by undercutting them and forwarding the assay work, whereby the competitor spends $1 to force them to spend $10).
2. Patent trolls (are they really trolls if they spent money to develop the technology and make a product based on it?) won't know what to sue them for.
Wouldn't it be fairly easy to determine their FP/FN figures just by sending them lots of blood samples with known composition? If it's a black box, use black-box testing methods.
The technology has already been developed and proven in an academic setting. It's mature enough that you can find cheap textbooks for it. Microfluidic assays (which can be combined, like circuits, on a silicon chip) for every conceivable metric of interest have been developed, debugged, and sold to incumbent diagnostics companies. It was only a matter of time before someone integrated them, but the "usual suspects" were tripped up by market kinetics:
No academic group has been sufficiently capitalized to pursue an "Integrate All The Assays" (IATA) project. A lab typically pursues 2 or 3 assays at a time, which they will often integrate into a "µTAS" which is academic slang for IATA but should get its own term because typical µTASs measure 2 or 3 things which is far below the potential of the technology (what I'm terming "IATA").
Industrial groups that were in a position to go IATA already had hard-won silos in the payola+bundling ridden rat's nest of the medical supply industry. They wanted to keep those (payola+bundling = low competition and high margins) and they didn't want to fight the war-on-many-fronts that would arise if they tried to invade everyone else's silos at once. The big risk is that their competitors in every silo could undercut/outmaneuver them in individual silos faster than they could weave a political network to unify purchasing across silos.
Well, now someone has figured out how to do just that. Strategy: lots of money, lots of connections, and a killer entry strategy. It's all in the execution, as always.
Two interesting questions to keep in mind as this plays out:
1. Now that someone has gone IATA, will the medical device supply industry become truly competitive again? I think there's a nonzero chance of that happening. That would be a dream come true for consumers and medtech startups alike.
2. How much of the proceeds will filter back to the people who actually developed the technology? Obviously the answer will be "a teeny tiny fraction," but the amount in absolute terms will be an important indicator (to me, personally, and I suspect others) as to how well the patent system works in this sector. Will it be like the software sector (patents discourage implementation AND don't encourage innovation) or will it be like the drug sector (patents function more or less as they were intended albeit with the caveat that a lion's share of the proceeds flows, as it always does, to capital)?
FTA, it seems she's front-running some approvals requirements and the sales / payola cycle by running a testing lab as well as developing the tests.
To IT people, this is counterintuitive. You don't vertically integrate, you go for a horizontal slice. Intel won by making chips, not making whole systems (like IBM did).
I guess vertical integration might make more sense in healthcare though, for regulatory and market reasons. I guess the market might be a bit more like IBM renting out mainframes than Intel selling CPU to OEMs. Also, making the tests cheaper (which is the main thing she's doing) might be unattractive to labs, if cost-plus pricing is popular - existing providers might not want to cut their prices.
The premise appears to be that they take extremely small samples ("25 to 50 microliters") and run lots of tests ("as many as 70 different tests from a single draw") using "the same fundamental chemical methods".
This compares with standard blood tests which require 2 orders of magnitude more blood ("numerous tubes of blood, each containing 3,000- to 5,000-microliter samples").
How does one produce reliable output with the same sensitivity/specificity using the same chemistry with so much less blood? I find it hard to believe that the existing lab procedures left that much efficiency on the table...