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Welcome to BIOTECH NATION !!! With understandable interviews requiring no background in science, BTN attracts a wide global audience. From everyday people looking for hope in treatments in development, to bioentrepreneurs interested in the experience of their fellow travelers, to venture capitalists looking for possibilities in cutting-edge breakthroughs, to scientists simply interested in the work of others, BioTech Nation is the voice of human endeavor, driving science to new realities for everyone. These interviews are drawn directly from the public radio program, "Tech Nation", which also can be heard in numerous global radio and podcasting venues.
Condition that according to the World Health Organization causes 1 in 5 deaths globally. Yes. 20%. I'm not sure all that many of us would come up with the right answer. And the right answer is the highly dangerous and potentially lethal medical condition known as sepsis.
Dr. Moira Gunn:Here in the United States, nearly 2,000,000 American adults develop sepsis annually. And for 350,000 of these adults, it leads to organ failure and death. In some ways, these numbers are not surprising, and that there has been no definitive diagnostic test which clearly identifies sepsis so that medical personnel can take quick and effective action. For one thing, sepsis must also be distinguished from another medical condition with very similar symptoms called SIRS. Unfortunately, when it is sepsis, hours matter.
Dr. Moira Gunn:Doctor Rollie Carlson is the CEO of immune express. Its under one hour test, septoCyte, has been cleared by the FDA, the EU, and Australia and is now being reviewed for use in a number of hospital systems in the US and globally. Doctor Carlson, welcome to the program.
Dr. Rollie Carlson:Thank you. Great to be here.
Dr. Moira Gunn:Now I have to say that independent of whatever might land you in a hospital, there's one word which immediately gets your attention and everyone's attention, and that word is sepsis. What is sepsis? Who can get it? And why is it so dangerous?
Dr. Rollie Carlson:Well, sepsis is a life threatening organ dysfunction that's due to your body's dysregulated host response to an infection, And essentially what happens is you have your body is trying to fight an infection and you start to have a hyper inflammatory response throughout your body. And this can lead to ultimately organ dysfunction. You can have leakage of blood vessels and damage to vital organs and ultimately death. Both the elderly and the very young are most susceptible to this, but actually all ages are susceptible to to sepsis.
Dr. Moira Gunn:Well the very young, how how young is very young?
Dr. Rollie Carlson:Well actually we've done studies all the way down to 1 year old, ourselves and is actually most susceptible in the in the 1, 2, 3 year olds, and then as you get older in children then less so.
Dr. Moira Gunn:So it's not an infection in itself. It's when your body sees a reason to have some extreme response to an existing infection in your body.
Dr. Rollie Carlson:Yes. We call it inflammatory response syndrome. And so you start overreacting to what is going to be an insult. It's the early signs of sepsis are identical to what we call systemic inflammatory response syndrome or SIRS. But however, sepsis, the results, you know, specifically from an infection and so you can have early detection of that while SIRS could be associated with a number of variables.
Dr. Rollie Carlson:Doctors typically look about 14 different ones including age, fever, white blood cell count, things along those lines. Basically it looks like SIRS is something that's ephemeral. It could be caused by trauma. It could be caused by pancreatitis, but it will go away. It's not gonna lead to high mortality or morbidity.
Dr. Moira Gunn:So there is a problem with is it sepsis or is it SIRS?
Dr. Rollie Carlson:Correct.
Dr. Moira Gunn:Is there any other thing it could be confused with?
Dr. Rollie Carlson:Well, many times I mean, you can have a a a bloodstream infection, but that does not necessarily lead to sepsis. You just have to have that that hyper immune response. Now what's starting to happen is with novel therapies such as CAR T therapies, which are being used for T cell transformation and oncology, you have what is called cytokine release syndrome, which looks very much like sepsis. And these patients actually have a hyper response to the the t cell injections, but also simultaneously these are highly susceptible to sepsis as well. So being able to differentiate between what is called CRS and sepsis is very important.
Dr. Moira Gunn:I'm getting the picture here that any number of things can cause our system to go into overload, and here comes sepsis, but it may be something else. It's difficult to diagnose. Now ImmuneXpress has developed a test. The first one, it has been cleared by the FDA and in Europe and the EU and in Australia, which can diagnose sepsis in under an hour. And, it's a blood test.
Dr. Moira Gunn:How does this sepsis test work, and and why haven't we had one before?
Dr. Rollie Carlson:Well, it hasn't been easy. There's multiple approaches, but our approach for septicide was, to do a test on in blood and where we measure mRNA on the surface of white blood cells. And remember, mRNA, which is associated with your COVID test, this is the same type of test that can be done on different types of genes. And the test basically says, if you have a systemic inflammatory response with an infection, that equals sepsis. And if there's not an infection, it equals SIRS.
Dr. Moira Gunn:So you're able to determine which it is, SIRS or or sepsis or neither?
Dr. Rollie Carlson:Exactly.
Dr. Moira Gunn:Now I understand that there are like 10 major causes of sepsis. How does that translate into what you're doing?
Dr. Rollie Carlson:Well, the three leading causes of sepsis are, primarily bacterium, whether it's gram positive or negative, viruses. COVID is also was a cause of viral sepsis and also fungi. And what our test does, it's agnostic to those. Any of those can cause, sepsis and and also, it needs to be differentiated with SIRS. And our test is able to, get a very clear signal for any of those pathogens.
Dr. Moira Gunn:And let's realize for those people that we know that have developed sepsis, they've had all kinds of underlying conditions and diseases, when they went into the hospital and they developed sepsis. So you have it doesn't matter where it came from. That's what you have to look at. And that is complicated.
Dr. Rollie Carlson:It's very complicated. And the the issue can be where you have pay patients that could be coming in because they've been under other types of medications and and treatments. And some of those are actually immunosuppressants, which actually could affect a test like ours. So we actually did very many clinical studies to be able to determine whether or not we can get this signal to tell that whether you have sepsis or or SIRS and we've we've addressed that. And we've seen that all the way from immunocompromised patients under cancer treatment, HIV patients, many many other sorts of situations.
Dr. Moira Gunn:Now, of course, this is all about me. Why isn't this everywhere? I know it's new, but what what's the problem with adoption, like, everywhere instantly?
Dr. Rollie Carlson:Well, this is a novel technology, and and actually treating what, physicians have been been been taught differently is something that you is, really 1, you need clinical proof for sure. But then after that, it's many physicians are are are locked into the way that they want to address a situation. And in sepsis, the default has always been, well, if I suspected sepsis, then I'm just gonna go ahead and treat with broad spectrum antibiotics and and see if the patient improves. But it's it's actually much more nuanced than that because 42% of patients that have been admitted and treated for for sepsis actually did not have it. So therefore and these these are patients that are sick.
Dr. Rollie Carlson:They were admitted into the ICU or the hospital for and there was something else going on. So therefore, making sure that you could distinguish this early on and start looking for something else that could be, cardiovascular, it could be a stroke, or other other types of things, you need to be able to direct those patients to for the right right application.
Dr. Moira Gunn:And in fact, if you go in there and you don't have sepsis and you have this major, treatment with antibiotics, that could be dangerous in itself.
Dr. Rollie Carlson:Absolutely. I mean, one one thing that is happening in the very as CDC and also CMS and the US are very concerned about, is the overuse of antibiotics because it's leading to, antibiotics antibiotic resistant organisms, which is is proliferating a lot. And we're down to our last line of defenses on of antibiotics.
Dr. Moira Gunn:Now you actually mentioned this, but I wanna be clear about it. Do any of the medications that I might regularly take or medical conditions that I might have interfere with this sepsis test?
Dr. Rollie Carlson:The answer is we have not found one. We've we've done multiple types of medications, for our FDA requirement. There are interfering substances, and we've expanded that actually tenfold, to understand how the test could or would be affected by this. And I'm very pleased to see that that indeed the test is is agnostic to medications that we found, even those that you would think that might be able to actually suppress a gene expression's signature.
Dr. Moira Gunn:Now here's the the really serious question. It's one thing to say, you know, some 40% of doctors, you know, treat for sepsis anyway even if it's there. But let's say I go in and they miss it. They misdiagnosis. They don't treat the sepsis.
Dr. Moira Gunn:How serious is that? What happens then?
Dr. Rollie Carlson:Oh, it's extremely serious. I mean, there's it's well known in the literature that if you truly do have sepsis, as each hour goes by, your probability of mortality increases by 8%. So if after 10 hours, that could be a pretty fatal situation. So understanding whether or not you have sepsis early on and then being able to go down the right treatment path is is very important. Let's remember, that sepsis is between in the top three leading causes of death in in in the US.
Dr. Rollie Carlson:It's actually responsible, for the greatest single expenditures in hospitals over $60,000,000,000 per year. But as far as the number of patients in an in admitted into a hospital for sepsis, it only accounts for 6% of patients.
Dr. Moira Gunn:So a lot of people are missing it.
Dr. Rollie Carlson:Exactly.
Dr. Moira Gunn:Yeah. Well, doctor Carlson, thank you so much. And as time goes on, I hope you'll come back and talk to us again and, let's see what kind of impact this could have.
Dr. Rollie Carlson:Well, I appreciate you having me, Moira, and I'd be happy to come back.
Dr. Moira Gunn:Doctor Rollie Carlson is the CEO of Immunexpress. More information about its test, SeptiCyte, can be found at ImmuneXpress. That's immune, I m m u n e, express, express.