November 13, 2024 • 12 mins
This week on BioTech Nation, Dr. Rollie Carlson, CEO of Immunexpress, talks about Sepsis—a deadly condition responsible for 1 in 5 deaths worldwide. Dr. Carlson talks about the FDA-cleared SeptiCyte test, a new tool that can quickly identify Sepsis within an hour, helping doctors treat it faster and avoid unnecessary antibiotics or even death.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Dr. Moira Gunn (00:11):
Condition that according to the World Health
Organization causes 1 in 5deaths globally. Yes. 20%. I'm
not sure all that many of uswould come up with the right
answer. And the right answer isthe highly dangerous and
potentially lethal medicalcondition known as sepsis.
(00:32):
Here in the United States,nearly 2,000,000 American adults
develop sepsis annually. And for350,000 of these adults, it
leads to organ failure anddeath. In some ways, these
numbers are not surprising, andthat there has been no
definitive diagnostic test whichclearly identifies sepsis so
(00:54):
that medical personnel can takequick and effective action. For
one thing, sepsis must also bedistinguished from another
medical condition with verysimilar symptoms called SIRS.
Unfortunately, when it issepsis, hours matter.
Doctor Rollie Carlson is the CEOof immune express. Its under one
(01:18):
hour test, septoCyte, has beencleared by the FDA, the EU, and
Australia and is now beingreviewed for use in a number of
hospital systems in the US andglobally. Doctor Carlson,
welcome to the program.
Dr. Rollie Carlson (01:34):
Thank you. Great to be here.
Dr. Moira Gunn (01:35):
Now I have to say that independent of whatever
might land you in a hospital,there's one word which
immediately gets your attentionand everyone's attention, and
that word is sepsis. What issepsis? Who can get it? And why
is it so dangerous?
Dr. Rollie Carlson (01:52):
Well, sepsis is a life threatening organ
dysfunction that's due to yourbody's dysregulated host
response to an infection, Andessentially what happens is you
have your body is trying tofight an infection and you start
to have a hyper inflammatoryresponse throughout your body.
And this can lead to ultimatelyorgan dysfunction. You can have
(02:15):
leakage of blood vessels anddamage to vital organs and
ultimately death. Both theelderly and the very young are
most susceptible to this, butactually all ages are
susceptible to to sepsis.
Dr. Moira Gunn (02:27):
Well the very young, how how young is very
young?
Dr. Rollie Carlson (02:30):
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 (02:44):
So it's not an infection in itself. It's when
your body sees a reason to havesome extreme response to an
existing infection in your body.
Dr. Rollie Carlson (02:54):
Yes. We call it inflammatory response
syndrome. And so you startoverreacting to what is going to
be an insult. It's the earlysigns of sepsis are identical to
what we call systemicinflammatory response syndrome
or SIRS. But however, sepsis,the results, you know,
specifically from an infectionand so you can have early
(03:16):
detection of that while SIRScould be associated with a
number of variables.
Doctors typically look about 14different ones including age,
fever, white blood cell count,things along those lines.
Basically it looks like SIRS issomething that's ephemeral. It
could be caused by trauma. Itcould be caused by pancreatitis,
(03:38):
but it will go away. It's notgonna lead to high mortality or
morbidity.
Dr. Moira Gunn (03:42):
So there is a problem with is it sepsis or is
it SIRS?
Dr. Rollie Carlson (03:47):
Correct.
Dr. Moira Gunn (03:47):
Is there any other thing it could be confused
with?
Dr. Rollie Carlson (03:50):
Well, many times I mean, you can have a a a
bloodstream infection, but thatdoes not necessarily lead to
sepsis. You just have to havethat that hyper immune response.
Now what's starting to happen iswith novel therapies such as CAR
T therapies, which are beingused for T cell transformation
(04:10):
and oncology, you have what iscalled cytokine release
syndrome, which looks very muchlike sepsis. And these patients
actually have a hyper responseto the the t cell injections,
but also simultaneously theseare highly susceptible to sepsis
as well. So being able todifferentiate between what is
(04:33):
called CRS and sepsis is veryimportant.
Dr. Moira Gunn (04:37):
I'm getting the picture here that any number of
things can cause our system togo into overload, and here comes
sepsis, but it may be somethingelse. It's difficult to
diagnose. Now ImmuneXpress hasdeveloped a test. The first one,
it has been cleared by the FDAand in Europe and the EU and in
(04:59):
Australia, which can diagnosesepsis in under an hour. And,
it's a blood test.
How does this sepsis test work,and and why haven't we had one
before?
Dr. Rollie Carlson (05:14):
Well, it hasn't been easy. There's
multiple approaches, but ourapproach for septicide was, to
do a test on in blood and wherewe measure mRNA on the surface
of white blood cells. Andremember, mRNA, which is
associated with your COVID test,this is the same type of test
(05:36):
that can be done on differenttypes of genes. And the test
basically says, if you have asystemic inflammatory response
with an infection, that equalssepsis. And if there's not an
infection, it equals SIRS.
Dr. Moira Gunn (05:51):
So you're able to determine which it is, SIRS
or or sepsis or neither?
Dr. Rollie Carlson (05:59):
Exactly.
Dr. Moira Gunn (06:00):
Now I understand that there are like 10 major
causes of sepsis. How does thattranslate into what you're
doing?
Dr. Rollie Carlson (06:08):
Well, the three leading causes of sepsis
are, primarily bacterium,whether it's gram positive or
negative, viruses. COVID is alsowas a cause of viral sepsis and
also fungi. And what our testdoes, it's agnostic to those.
(06:28):
Any of those can cause, sepsisand and also, it needs to be
differentiated with SIRS. Andour test is able to, get a very
clear signal for any of thosepathogens.
Dr. Moira Gunn (06:41):
And let's realize for those people that we
know that have developed sepsis,they've had all kinds of
underlying conditions anddiseases, when they went into
the hospital and they developedsepsis. 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 (07:00):
It's very complicated. And the the issue
can be where you have paypatients that could be coming in
because they've been under othertypes of medications and and
treatments. And some of thoseare actually immunosuppressants,
which actually could affect atest like ours. So we actually
did very many clinical studiesto be able to determine whether
(07:24):
or not we can get this signal totell that whether you have
sepsis or or SIRS and we'vewe've addressed that. And we've
seen that all the way fromimmunocompromised patients under
cancer treatment, HIV patients,many many other sorts of
situations.
Dr. Moira Gunn (07:43):
Now, of course, this is all about me. Why isn't
this everywhere? I know it'snew, but what what's the problem
with adoption, like, everywhereinstantly?
Dr. Rollie Carlson (07:53):
Well, this is a novel technology, and and
actually treating what,physicians have been been been
taught differently is somethingthat you is, really 1, you need
clinical proof for sure. Butthen after that, it's many
physicians are are are lockedinto the way that they want to
address a situation. And insepsis, the default has always
(08:18):
been, well, if I suspectedsepsis, then I'm just gonna go
ahead and treat with broadspectrum antibiotics and and see
if the patient improves. Butit's it's actually much more
nuanced than that because 42% ofpatients that have been admitted
and treated for for sepsisactually did not have it. So
(08:39):
therefore and these these arepatients that are sick.
They were admitted into the ICUor the hospital for and there
was something else going on. Sotherefore, making sure that you
could distinguish this early onand start looking for something
else that could be,cardiovascular, it could be a
stroke, or other other types ofthings, you need to be able to
direct those patients to for theright right application.
Dr. Moira Gunn (09:01):
And in fact, if you go in there and you don't
have sepsis and you have thismajor, treatment with
antibiotics, that could bedangerous in itself.
Dr. Rollie Carlson (09:11):
Absolutely. I mean, one one thing that is
happening in the very as CDC andalso CMS and the US are very
concerned about, is the overuseof antibiotics because it's
leading to, antibioticsantibiotic resistant organisms,
which is is proliferating a lot.And we're down to our last line
(09:33):
of defenses on of antibiotics.
Dr. Moira Gunn (09:36):
Now you actually mentioned this, but I wanna be
clear about it. Do any of themedications that I might
regularly take or medicalconditions that I might have
interfere with this sepsis test?
Dr. Rollie Carlson (09:51):
The answer is we have not found one. We've
we've done multiple types ofmedications, for our FDA
requirement. There areinterfering substances, and
we've expanded that actuallytenfold, to understand how the
test could or would be affectedby this. And I'm very pleased to
see that that indeed the test isis agnostic to medications that
(10:16):
we found, even those that youwould think that might be able
to actually suppress a geneexpression's signature.
Dr. Moira Gunn (10:24):
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 ifit's there. But let's say I go
in and they miss it. Theymisdiagnosis. They don't treat
the sepsis.
How serious is that? Whathappens then?
Dr. Rollie Carlson (10:46):
Oh, it's extremely serious. I mean,
there's it's well known in theliterature that if you truly do
have sepsis, as each hour goesby, your probability of
mortality increases by 8%. So ifafter 10 hours, that could be a
pretty fatal situation. Sounderstanding whether or not you
(11:08):
have sepsis early on and thenbeing able to go down the right
treatment path is is veryimportant. Let's remember, that
sepsis is between in the topthree leading causes of death in
in in the US.
It's actually responsible, forthe greatest single expenditures
in hospitals over$60,000,000,000 per year. But as
(11:29):
far as the number of patients inan in admitted into a hospital
for sepsis, it only accounts for6% of patients.
Dr. Moira Gunn (11:36):
So a lot of people are missing it.
Dr. Rollie Carlson (11:39):
Exactly.
Dr. Moira Gunn (11:40):
Yeah. Well, doctor Carlson, thank you so
much. And as time goes on, Ihope you'll come back and talk
to us again and, let's see whatkind of impact this could have.
Dr. Rollie Carlson (11:50):
Well, I appreciate you having me, Moira,
and I'd be happy to come back.
Dr. Moira Gunn (11:53):
Doctor Rollie Carlson is the CEO of
Immunexpress. More informationabout its test, SeptiCyte, can
be found at ImmuneXpress. That'simmune, I m m u n e, express,
express.
Condition that according to the World Health
Organization causes 1 in 5deaths globally. Yes. 20%. I'm
not sure all that many of uswould come up with the right
answer. And the right answer isthe highly dangerous and
potentially lethal medicalcondition known as sepsis.
(00:32):
Here in the United States,nearly 2,000,000 American adults
develop sepsis annually. And for350,000 of these adults, it
leads to organ failure anddeath. In some ways, these
numbers are not surprising, andthat there has been no
definitive diagnostic test whichclearly identifies sepsis so
(00:54):
that medical personnel can takequick and effective action. For
one thing, sepsis must also bedistinguished from another
medical condition with verysimilar symptoms called SIRS.
Unfortunately, when it issepsis, hours matter.
Doctor Rollie Carlson is the CEOof immune express. Its under one
(01:18):
hour test, septoCyte, has beencleared by the FDA, the EU, and
Australia and is now beingreviewed for use in a number of
hospital systems in the US andglobally. Doctor Carlson,
welcome to the program.
Dr. Rollie Carlson (01:34):
Thank you. Great to be here.
Dr. Moira Gunn (01:35):
Now I have to say that independent of whatever
might land you in a hospital,there's one word which
immediately gets your attentionand everyone's attention, and
that word is sepsis. What issepsis? Who can get it? And why
is it so dangerous?
Dr. Rollie Carlson (01:52):
Well, sepsis is a life threatening organ
dysfunction that's due to yourbody's dysregulated host
response to an infection, Andessentially what happens is you
have your body is trying tofight an infection and you start
to have a hyper inflammatoryresponse throughout your body.
And this can lead to ultimatelyorgan dysfunction. You can have
(02:15):
leakage of blood vessels anddamage to vital organs and
ultimately death. Both theelderly and the very young are
most susceptible to this, butactually all ages are
susceptible to to sepsis.
Dr. Moira Gunn (02:27):
Well the very young, how how young is very
young?
Dr. Rollie Carlson (02:30):
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 (02:44):
So it's not an infection in itself. It's when
your body sees a reason to havesome extreme response to an
existing infection in your body.
Dr. Rollie Carlson (02:54):
Yes. We call it inflammatory response
syndrome. And so you startoverreacting to what is going to
be an insult. It's the earlysigns of sepsis are identical to
what we call systemicinflammatory response syndrome
or SIRS. But however, sepsis,the results, you know,
specifically from an infectionand so you can have early
(03:16):
detection of that while SIRScould be associated with a
number of variables.
Doctors typically look about 14different ones including age,
fever, white blood cell count,things along those lines.
Basically it looks like SIRS issomething that's ephemeral. It
could be caused by trauma. Itcould be caused by pancreatitis,
(03:38):
but it will go away. It's notgonna lead to high mortality or
morbidity.
Dr. Moira Gunn (03:42):
So there is a problem with is it sepsis or is
it SIRS?
Dr. Rollie Carlson (03:47):
Correct.
Dr. Moira Gunn (03:47):
Is there any other thing it could be confused
with?
Dr. Rollie Carlson (03:50):
Well, many times I mean, you can have a a a
bloodstream infection, but thatdoes not necessarily lead to
sepsis. You just have to havethat that hyper immune response.
Now what's starting to happen iswith novel therapies such as CAR
T therapies, which are beingused for T cell transformation
(04:10):
and oncology, you have what iscalled cytokine release
syndrome, which looks very muchlike sepsis. And these patients
actually have a hyper responseto the the t cell injections,
but also simultaneously theseare highly susceptible to sepsis
as well. So being able todifferentiate between what is
(04:33):
called CRS and sepsis is veryimportant.
Dr. Moira Gunn (04:37):
I'm getting the picture here that any number of
things can cause our system togo into overload, and here comes
sepsis, but it may be somethingelse. It's difficult to
diagnose. Now ImmuneXpress hasdeveloped a test. The first one,
it has been cleared by the FDAand in Europe and the EU and in
(04:59):
Australia, which can diagnosesepsis in under an hour. And,
it's a blood test.
How does this sepsis test work,and and why haven't we had one
before?
Dr. Rollie Carlson (05:14):
Well, it hasn't been easy. There's
multiple approaches, but ourapproach for septicide was, to
do a test on in blood and wherewe measure mRNA on the surface
of white blood cells. Andremember, mRNA, which is
associated with your COVID test,this is the same type of test
(05:36):
that can be done on differenttypes of genes. And the test
basically says, if you have asystemic inflammatory response
with an infection, that equalssepsis. And if there's not an
infection, it equals SIRS.
Dr. Moira Gunn (05:51):
So you're able to determine which it is, SIRS
or or sepsis or neither?
Dr. Rollie Carlson (05:59):
Exactly.
Dr. Moira Gunn (06:00):
Now I understand that there are like 10 major
causes of sepsis. How does thattranslate into what you're
doing?
Dr. Rollie Carlson (06:08):
Well, the three leading causes of sepsis
are, primarily bacterium,whether it's gram positive or
negative, viruses. COVID is alsowas a cause of viral sepsis and
also fungi. And what our testdoes, it's agnostic to those.
(06:28):
Any of those can cause, sepsisand and also, it needs to be
differentiated with SIRS. Andour test is able to, get a very
clear signal for any of thosepathogens.
Dr. Moira Gunn (06:41):
And let's realize for those people that we
know that have developed sepsis,they've had all kinds of
underlying conditions anddiseases, when they went into
the hospital and they developedsepsis. 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 (07:00):
It's very complicated. And the the issue
can be where you have paypatients that could be coming in
because they've been under othertypes of medications and and
treatments. And some of thoseare actually immunosuppressants,
which actually could affect atest like ours. So we actually
did very many clinical studiesto be able to determine whether
(07:24):
or not we can get this signal totell that whether you have
sepsis or or SIRS and we'vewe've addressed that. And we've
seen that all the way fromimmunocompromised patients under
cancer treatment, HIV patients,many many other sorts of
situations.
Dr. Moira Gunn (07:43):
Now, of course, this is all about me. Why isn't
this everywhere? I know it'snew, but what what's the problem
with adoption, like, everywhereinstantly?
Dr. Rollie Carlson (07:53):
Well, this is a novel technology, and and
actually treating what,physicians have been been been
taught differently is somethingthat you is, really 1, you need
clinical proof for sure. Butthen after that, it's many
physicians are are are lockedinto the way that they want to
address a situation. And insepsis, the default has always
(08:18):
been, well, if I suspectedsepsis, then I'm just gonna go
ahead and treat with broadspectrum antibiotics and and see
if the patient improves. Butit's it's actually much more
nuanced than that because 42% ofpatients that have been admitted
and treated for for sepsisactually did not have it. So
(08:39):
therefore and these these arepatients that are sick.
They were admitted into the ICUor the hospital for and there
was something else going on. Sotherefore, making sure that you
could distinguish this early onand start looking for something
else that could be,cardiovascular, it could be a
stroke, or other other types ofthings, you need to be able to
direct those patients to for theright right application.
Dr. Moira Gunn (09:01):
And in fact, if you go in there and you don't
have sepsis and you have thismajor, treatment with
antibiotics, that could bedangerous in itself.
Dr. Rollie Carlson (09:11):
Absolutely. I mean, one one thing that is
happening in the very as CDC andalso CMS and the US are very
concerned about, is the overuseof antibiotics because it's
leading to, antibioticsantibiotic resistant organisms,
which is is proliferating a lot.And we're down to our last line
(09:33):
of defenses on of antibiotics.
Dr. Moira Gunn (09:36):
Now you actually mentioned this, but I wanna be
clear about it. Do any of themedications that I might
regularly take or medicalconditions that I might have
interfere with this sepsis test?
Dr. Rollie Carlson (09:51):
The answer is we have not found one. We've
we've done multiple types ofmedications, for our FDA
requirement. There areinterfering substances, and
we've expanded that actuallytenfold, to understand how the
test could or would be affectedby this. And I'm very pleased to
see that that indeed the test isis agnostic to medications that
(10:16):
we found, even those that youwould think that might be able
to actually suppress a geneexpression's signature.
Dr. Moira Gunn (10:24):
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 ifit's there. But let's say I go
in and they miss it. Theymisdiagnosis. They don't treat
the sepsis.
How serious is that? Whathappens then?
Dr. Rollie Carlson (10:46):
Oh, it's extremely serious. I mean,
there's it's well known in theliterature that if you truly do
have sepsis, as each hour goesby, your probability of
mortality increases by 8%. So ifafter 10 hours, that could be a
pretty fatal situation. Sounderstanding whether or not you
(11:08):
have sepsis early on and thenbeing able to go down the right
treatment path is is veryimportant. Let's remember, that
sepsis is between in the topthree leading causes of death in
in in the US.
It's actually responsible, forthe greatest single expenditures
in hospitals over$60,000,000,000 per year. But as
(11:29):
far as the number of patients inan in admitted into a hospital
for sepsis, it only accounts for6% of patients.
Dr. Moira Gunn (11:36):
So a lot of people are missing it.
Dr. Rollie Carlson (11:39):
Exactly.
Dr. Moira Gunn (11:40):
Yeah. Well, doctor Carlson, thank you so
much. And as time goes on, Ihope you'll come back and talk
to us again and, let's see whatkind of impact this could have.
Dr. Rollie Carlson (11:50):
Well, I appreciate you having me, Moira,
and I'd be happy to come back.
Dr. Moira Gunn (11:53):
Doctor Rollie Carlson is the CEO of
Immunexpress. More informationabout its test, SeptiCyte, can
be found at ImmuneXpress. That'simmune, I m m u n e, express,
express.
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