3i Diagnostics receives Breakthrough Device designation from FDA for Technology that identifies infection-causing pathogens directly from blood in < 1 hour

Here’s what Health:Further’s Chief Medical Innovation Officer Mario Ramirez, MD, had to say:

Comment: “Seems pretty disruptive if it’s real.”

Ramirez: Could be….I’ll look into it. The real question–the real disrupter–is if it can tell which antibiotic the bacteria are sensitive to that quickly. That’s a different animal, but that’s the answer that can really accelerate clinical decision making. We usually have an idea someone’s infected pretty quickly and we can give antibiotics that cover everything within an hour….in fact, CMS judges ERs on how quickly they can deliver what’s called the “sepsis bundle” for these types of presumed infections. But, if this could actually tell which antibiotics we should be using in under an hour…well, that’s pretty interesting…

Question: They tried to say that they were taking a process that takes days down to hours. Was that technical marketing?

Ramirez: It is. While it’s true that cultures fo take 2 to 6 days, we have enough other information in the first hour to say that someone’s infected (their white blood cell count, lactic acid, and a few other things). In the right constellation, those markers already give us enough to predict someone’s infected and we put them on antibiotics in the first hour. Cell culture that takes 2 to 6 days is what can tell us which antibiotic they’re sensitive to…but they don’t mention that. Now, is there value in knowing for sure? (And is there an investment potential there?) Sure. And DoD or a number of other folks may get interested (reference Theranos and DoD)
But I don’t think it’s revolutionary from a science standpoint. The real questions these guys would need to answer are: does its use improve rapid tailoring of specific antibiotics and does it increase survivability? If those two answers are “yes” then I’m going to liquidate my 401 and put it all into this. 🙂

Note: We probably don’t need to say this but, um, that last sentence from Mario should not be construed as investment advice.

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