August 29, 2024 • 28 mins
Join us with guest Dr. Rolland Carlson, CEO of Immunexpress to talk about the transformative work happening in sepsis diagnosis.
Dr. Carlson discusses the importance of rapid sepsis diagnosis. The episode covers challenges faced during product development, regulatory achievements, and future plans for sepsis diagnostics. Dr. Carlson also shares advice on ensuring product quality and navigating FDA clearances.
00:00 Introduction to From Lab to Launch
00:25 Meet Dr. Rolland Carlson, CEO of Immunexpress
01:31 Challenges and Innovations in Sepsis Diagnosis
03:01 Impact of COVID-19 on Clinical Trials
04:17 The Vision Behind Septicite Rapid
05:17 Technical Insights into Sepsis Diagnosis
14:00 Regulatory Achievements and Quality Management
16:58 Integrating Septicite Rapid in Clinical Workflows
24:00 Future Innovations in Sepsis Diagnostics
25:34 A Personal Note from Dr. Carlson
26:29 Conclusion and Farewell
https://immunexpress.com/
https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/
Qualio website:
https://www.qualio.com/
Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast
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https://forms.gle/uUH2YtCFxJHrVGeL8
Music by keldez
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:01):
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Welcome to another episode of From Lab to Launch by
Polyo, where we delve into thelatest innovations and insights
from the life science industry.
I'm Meg, your host, and todaywe're thrilled to have Dr.
Roland Carlson, the CEO ofImmunexpress with us.
Raleigh has been at theforefront of transforming sepsis
diagnosis.
It's a critical conditionresponsible for millions of
(00:39):
deaths and significant healthcare costs globally.
Rapid and accurate diagnosis isparamount, and Immune Express
has developed a diagnostic toolthat significantly enhances the
ability to differentiate sepsisfrom non infectious inflammation
within an hour.
Raleigh has over 25 years inbiotechnology, serving as CEO a
(01:00):
few times, and held key roles atAbbott Laboratories, and this is
Inc in molecular diagnostics andbusiness development.
You can see his full bio in theshow notes.
Septicite Rapid, supported byextensive clinical trials and
peer reviewed publications, hasreceived FDA 510k clearance, CE
(01:22):
marking, and approval from theAustralian Therapeutic Goods
Administration.
Welcome, Raleigh.
Dr. Rollie Carlson (01:29):
Matt, great to be here.
Thank you.
Meg Sinclair (01:31):
Thanks.
So you've been the CEO of ImmuneExpress for over six years.
Can you tell us briefly how yougot connected to the company and
what it was like leading throughCOVID?
Um, it was probably a disruptivetime for the business, as I
imagine.
Dr. Rollie Carlson (01:45):
As it was for everybody, I'm sure.
Yes.
Yeah, I, um, I joined thecompany actually, uh, after a
career at Abbott, as youmentioned, where I was head both
by, uh, Diagnostics andpharmaceutical responsibilities.
And I, I left Abbott to join theentrepreneurial world.
So, um, and I left for startupsin Austin, Texas, and we founded
(02:07):
a company called Assurgen, whichnow has been purchased by
Biotechni, and later a NasdaqCEO company for Wafergen
Biosciences, and now ImmuneExpress.
Um, I knew Immune Express as inmy company in Austin.
We had built a assay based upontheir novel gene markers for for
(02:30):
sepsis, and they wanted to havea system by which they could do
clinical testing for.
So I was introduced to thecompany that way, um, and, uh,
and after my stint at WaverGen,I was gainfully unemployed and
the board was looking for somechanges of leadership.
And so they asked me to be theadvisor and one thing led to
(02:50):
another.
I came on as CEO.
Meg Sinclair (02:53):
Stars aligned.
Dr. Rollie Carlson (02:54):
Yes.
Um,
Meg Sinclair (02:56):
yeah.
And what kind of challenges didyou all face during?
COVID.
Dr. Rollie Carlson (03:01):
Well, with COVID, I think, as we were in
the middle of our, uh, clinicaltrials associated with our, our
diagnostic, we developed aproduct and we were quite
bullish about, you know, from atime, you know, not only
fundraising, but then alsogetting FDA clearance and COVID
put a wrench in the works quitea bit.
Uh, not only did it slow down,obviously hospitals were, were,
(03:23):
you know, The front line wasCOVID management at that point
in time and doing clinical workwas not, um, that high in their
priority.
And so, um, however, we knewthat the test and we had
developed and did studies in,in, in Europe very quickly that
found that the test was veryusable for COVID induced sepsis,
(03:43):
you know, as, as a result, so Idelayed our clinical trials for
probably a good year.
And then also we filed for theFDA.
And of course, they were lookingat approvals for COVID products.
And so, um, that delayed us agood another nine months or so.
And so, but we were fortunate.
We were the first non COVIDproduct in infectious disease to
(04:06):
get cleared by the FDA, uh,coming out the other end.
And so, uh, we were very pleasedwith
Meg Sinclair (04:12):
that.
Lots of stars aligning on yourside there.
Right.
Uh, so septicite.
Rapid is a groundbreaking toolin sepsis diagnosis.
Can you share with us theinspiration and initial vision
behind the development?
Dr. Rollie Carlson (04:25):
Yes.
Well, sepsis is really aconundrum, you know, where it's
one of the leading causes ofdeath in hot U.
S.
Hospitals.
Uh, there's been someimprovement as far as mortality
and morbidity, but it's verydifficult to diagnose.
And so physicians actuallyrelying on pretty archaic, uh,
uh, technologies from 100 yearsago of doing blood cultures and
(04:47):
waiting for 24 or 48 hours tosee if they can get a result.
And many times they don't get aresult.
So, you know, physicians arereally challenged to have a
multitude of inputs and to tryto diagnose sepsis early.
It's easy to diagnose sepsis.
Uh, when it leads to, uh, organfailure and, uh, and somebody's
in dire, dire straits.
(05:08):
However, early detection ofsepsis is, is, is quite
difficult.
So therefore, there's a lot ofjudgment that physicians have as
a consequence of that.
So the vision of our, our, ourtechnology was to actually
develop a test that could berapidly diagnosed.
sepsis in the early stage and beable to intervene with the
(05:29):
appropriate patients who areseptic.
But many times, 42 percent ofthe time, physicians believe
it's sepsis, but it's not.
So both ruling in and ruling outsepsis is very, very important
because it could be these peopleare sick.
There's some other ideology.
They should be treated forsomething else, or they should
look for something.
So the way to do that, whichhistorically has been to look
(05:50):
for pathogens, requires a numberof copy numbers of a bacteria or
virus or path or fungus to grow.
And what we were measuring andwe found that the human, uh,
substance is reallydysregulated, uh, systemic
inflammatory response syndromeas a result to a pathogen
(06:11):
infection.
And what that starts is your,your, your, your body is
actually hyper immuno reactingto the pathogen.
And it's really that hyperimmune response that actually
leads to cascade and ultimately,you know, high morbidity or more
mortality.
And so what it was important todo.
There's systemic inflammatoryresponse with no pathogen.
(06:33):
It's ephemeral.
If you were in a car accident oryou had chronic pancreatitis,
you might have symptoms ofsystemic inflammatory response.
And what we developed wasactually measuring the human
response from like blood cellswith a highly sensitive M.
R.
N.
A.
QPCR test that measuresdifferential expression of these
(06:54):
genes.
And these genes, what they'reable to do is, uh, on some in
the presence of a pathogen orhighly upregulated.
And the other one is not.
And then if there's not apathogen, then the one gene is
quite stable.
And the other one is actually,uh, lower expressed.
So we can measure it.
(07:15):
Uh, the algorithm, uh, and thatspits out a score of the
probability of sepsis from highto low.
Meg Sinclair (07:23):
Great.
And how is the speed importanthere with this new testing
compared to the old archaicmethods?
Dr. Rollie Carlson (07:29):
Well, um, the, it's pretty well known that
if somebody does have sepsis,uh, as each hour goes by, the
increased probability ofmortality goes up by 8%.
So if you're waiting for 12hours or so, yeah, obviously
that's a problem.
And so, uh, it was importantwhen we did our market research
is that you needed to have atest.
(07:51):
And the test, by the way, that Ioriginally, uh, developed in my
former company for the forimmune express was on a
conventional molecular platform,which was a plate based one,
which would take about 8 to 12hours.
And they were looking atretrospectively what was the
diagnosis and found a highcorrelation.
But for, from a marketabilitystandpoint, you really had to
(08:12):
have something that could Have aresult within one to two hours.
And so that was part of ourdesign goals for the test that
we have, uh, such a site rapid,uh, which is a sample to answer,
um, uh, product and, uh, veryeasy to use.
And we can have a turnaroundtime in one hour.
Meg Sinclair (08:32):
That's a big difference from eight hours.
Dr. Rollie Carlson (08:34):
Absolutely.
That's
Meg Sinclair (08:35):
such an improvement in patient outcomes,
I can imagine.
Dr. Rollie Carlson (08:39):
Indeed.
Indeed.
Meg Sinclair (08:42):
What else, um, with the subcyte rapid
performance compares to otherbiomarkers that you can share
with us?
Dr. Rollie Carlson (08:51):
Well, there's a number of, there's a
number of biomarkers and there'sother sort of symptomology, you
know, that, uh, that.
In clinical, clinical signs thatthat physicians look at.
And in sepsis it's probablyabout 12, uh, 12 of them, you
know, it'd be fever, high blood,white blood count, uh, uh, low
(09:11):
lactate levels.
Lactate is is something that'sused that's more about, uh,
perfusion and make sure that youhave the appropriate sort of
fluids associated with that.
Um, and other biomarkers arenonspecific.
In other words, there's there'ssome procalcitonin, which is
actually a a a marker that isvery specific for bacterial
(09:36):
infection and is not used.
It's used indirectly for sepsisdetection, but Uh, it's it's
labeled for actually withdrawalof antibiotics.
If somebody is responding tothat, uh, CRP is also used in
some occasions.
But what they have to do isreally take all of those
(09:56):
together and be able to come upwith a result.
And in our clinical trials, whatwe did was we looked at our
septus score result, which isthe result that we get from our
test compared to all those othervariables.
And it was Uh, well, well, whenyou combine those variables
together, then you get a, uh, animproved performance.
(10:16):
The CEPA score alone, uh, wasactually superior to all those
combined.
Um, so, um, instead of aphysician having to do a
multifactorial in their head ofthose 12 different things, then
they should be able to have thatscore.
Now, You know, you do need tolook at those other variables
because every, every, uh, everypatient has sort of a unique
(10:38):
situation.
And so, um, but, and so what welook at is if there's two sides
of that systemic inflammatoryresponse, uh, and, and physician
is suspicious of sepsis, thenyou should do a blood draw, um,
and which normally they would dofor cultures.
At the same time, they should dothis for cultures.
our test.
And what we found was that, youknow, within an hour, you could
(11:01):
have the result with a very highcorrelation.
If it led to a positive bloodculture, we had a very high,
probably high correlation withblood cultures.
But we have that result withinan hour where you had to wait
for 24 hours for the blood test.
Meg Sinclair (11:18):
And time is of the essence with sepsis.
So that's amazing.
Well, we talked a little bitabout your challenges with
COVID.
What are some of the mostsignificant challenges you faced
in the development and clinicalvalidation of septicide rapid?
Dr. Rollie Carlson (11:33):
Well, in my career, and I'm sure that, you
know, your, your listeners, aswell.
If you're looking at a productthat's, um, you're trying to
develop and, and you're actuallylooking at something that is
maybe a better mousetrap, maybeit's faster, cheaper, whatever
for an existing, the existingproduct, the, uh, what I'll call
the product market fit is, ispretty well defined.
(11:56):
Okay.
So, uh, if you have a betteroncology test, something that's
faster, You know, for EGFR, KRAS or something along those
lines are easier to handle.
So that, that is fairlystraightforward.
But when you get to a, aproduct, which is, which is in a
space that is novel and, andthere isn't a fixed application,
(12:17):
then that product market fit isvery important to understand
early in the process, uh,because, You can go down and
think, you know, internallybelieve that, you know, this is
the best thing since slicedbread.
But as a matter of fact, are youreally fulfilling a customer
need?
So you have to do the marketresearch up front.
You need to make sure that yourdesign goals fit that.
(12:40):
And you have to be pretty rigidabout that.
Is, is, do you meet those ornot?
For example, if we were tryingto develop a subsite rapid and,
um, it took three hours insteadof one hour.
Then you know what?
We usually go back to thedrawing board.
Don't try to go out with threehour test, you know, uh, in in
that regard.
And then the other thing is,it's a do the market research up
(13:03):
front.
And then, uh, and and I thinkthat as you're doing In the IBD
world in diagnostics, it'sdifferent than what you're doing
for a CLIA test, for sure.
Uh, you need to be able to lockdown what the specifications are
for getting FDA clearance anduh, other, other clearances.
And many times, companies,because of the rush to try to
(13:26):
get the product out, will lockdown those design goals.
Too early, and then they getdown the process and, uh, they
might find thatmanufacturability is a problem.
Things along those lines.
Mm-Hmm.
So, um, my philosophy, whichI've learned the hard way, is
stay in phys feasibility as longas you can to make sure that
you've asked the hard questionsthat you're able to over, you
(13:49):
know, achieve as far as those,those goals are concerned.
And then actually it's very easyto go through that design
process.
Meg Sinclair (13:58):
Great advice.
Speaking of your 510k clearanceand CE marking, you've also
gotten the AustralianTherapeutics Goods
Administration approval.
That's quite the regulatory, um,quality achievements and quality
management is at the heart ofwhat we do here at Qualio, so
have to ask, um, how doesImmunexpress ensure the
reliability and accuracy of yourproducts and instill a quality
(14:20):
of culture?
Dr. Rollie Carlson (14:23):
Well, I think that number one, I mean,
if you're in this business, youhave to aspire to have the
highest quality to fulfill yourcustomers.
And we're talking about serious,you know, medical devices and
diagnoses, and you have toensure that you're providing
your customers and yourpatients, you know, quite
frankly, the highest qualityproduct.
Um, I had the benefit of Oflearning within the Abbott
(14:48):
system, so to speak, you knowthat you needed to really have
being lockstep with qualityquality regulatory early on in
the process, and particularlyfor founders.
And I've worked with founderswho had That it might, for
example, the company in Austinthat I joined, the co founder
there was, you know, a fantasticscientist and very successful in
(15:11):
the life science world and hadnever done anything in the
quality regulatory sort of, uh,and the appreciation of that,
you know, one tends to discountif you haven't gone through
that, but that can come backclearly to, uh, be, be an issue.
So, uh, engaging quality andregulatory, which I, You know,
as as key members of the team,not just something that you sort
(15:33):
of throw over the wall.
You can't do that to besuccessful, you know, in that
regard.
And I've been very proud of theteam that we have, you know, in
achieving the accomplishmentswe've had.
We have at the Express, they'reexperience both domestically and
internationally.
And, you know, if you work withthe agencies up front too, um,
(15:57):
and making sure that you, insome cases, and particularly in
this situation where you have anovel product like Ceptoside
Rapid, you need to go throughand engage the agency early on
and saying, this is what we'replanning on doing.
Do you have the input before wespend, you know, millions of
dollars on clinical trials, etcetera.
Meg Sinclair (16:17):
Yeah, great advice.
Those early FDA meetings arealways worth having, especially
with those novel devices to, toknow where you need to chart
your map.
Dr. Rollie Carlson (16:26):
Indeed.
And sometimes you get feedbackthat you don't, you really don't
want to hear, but it's veryimportant to get that early on
because if you spend, you know,uh, your investors money and you
have expectations for clearancesand, and you have a, um, a
hiccup.
And I think there's someexperiences, you know, fairly
recently with companies wherethey went all the way down the
(16:47):
path and they couldn't get FDAclearance.
And that obviously, uh,
Meg Sinclair (16:53):
Yeah, too late to pivot at that point.
So exactly.
How does stuff to say rapid testintegrate with current clinical
workflows in hospitals and whatfeedback have you received thus
far from healthcare providers?
Dr. Rollie Carlson (17:08):
Well, what we found with sepsis, and not
only in Europe and the U.
S., it's, it's managed verydifferently by different
institutions, uh, but, and, andthere's many sort of
stakeholders associated withsepsis management.
If you're trying to be able toidentify sepsis in the emergency
(17:28):
room, uh, department, then whatyou're trying to do is, you you
know, quickly rule in, rule outin that.
Um, our test is really not forscreening, you know, a patient
who might come in with a feverand and looks a little a little
sick or so.
It's really somebody that'sstrong, especially suspected of
being sepsis.
And you know what?
(17:50):
The different stakeholdersassociated with sepsis
management are going to be, uh,critical care, uh, patients.
doctors, nurses, E.
D.
Doc.
That's going to be doing theadmissions.
And then ultimately, um, youknow, the infectious disease,
uh, doctor that after patient isis admitted.
And what happens is initiallythere's gonna be an order set.
(18:12):
Different hospitals will say, ifI suspect, uh, that there's
going to be a patient ofsubstance, they'll say, I want
to, uh, uh, draw blood forlactates for a look at, uh, WBC,
white blood cell counts.
Uh, and they call these things,uh, sepsis bundles, and there
(18:32):
are sort of three or four keycriteria, um, by which they're
going to react to.
And the, uh, there are, thereare international guidelines
associated with that, uh, butthey're, you know, they are not
something that everybodyfollows.
Um, in the U.
S.
C.
M.
S.
Has actually, uh, been prettyprescriptive as far as what they
(18:55):
call, uh, set one bundles whereif you suspect somebody to have,
uh, substance, you need toeither you need to either
administer antibiotics and treatthem within three hours or not.
And you need to know one.
Is there an infection?
And two, is there is a systemicinflammatory response, which is
exactly what our test does.
(19:16):
So as we what we're doing iswe're when we approach
customers.
What one?
What is what are you doing forsepsis?
Uh, to what is your need?
Because in some cases, you know,it's the inpatient sepsis.
That's their biggest problem.
They got their process foradmitting etcetera like that
into.
(19:36):
But when a patient ends up inthe hospital, then what?
What?
What happens?
And to them and in other cases,we have too many people coming
through the E.
D.
We can't answer that.
We can't triage them fastenough.
So we want to be able to bucketthem.
You know, that's, that'sassociated with it.
So we, we try to, uh, and many,um, hospitals want to do an
(20:00):
evaluation.
I mean, for us, it's importantto do an evaluation to try to
meet their unmet, their unmetneed.
Right.
So that's, that's, that's ourapproach, right?
I think that we, our test reallyhelps drive compliance to, uh,
uh, the CMS, uh, substancebundles, you know, and I think
(20:20):
there's a good recognition from,um, uh, from hospitals
associated with that.
Um, and I think that as we haveused the test is being used,
there's some interesting youknow, results.
First off, I made that commentabout 42 percent of the time
(20:41):
physician thinks it's sepsis.
It's not so that's beingverified.
And so, uh, major customers aresaying, Wow, we're really
surprised how many people wethought had such a stone, you
know.
But then, on the other hand, Uh,there's, they're saying, wow,
you guys really highly correlatewith blood culture if it's
positive and we're ruling inanother use case would be post
(21:05):
surgery.
If you have patients that arehaving having surgery, there'll
be the surgical ICU.
There's a lot of concern aboutinfection.
Um, and and can they be reallydischarged to the ward for for
recovery and looking at our testas far as ruling rule out is
(21:25):
important.
And if they if our test ispositive, and I'm not sure if
your listeners are aware, butright now there's a blood
culture bottle shortage rightnow that the FDA has put out
notice for.
Um, and the blood cultureindustry is still very, very
large.
Um, but right now there's ashortage of that.
And what we found was, is thatwith our test for positive,
(21:49):
actually, you would like todouble up your blood cultures,
uh, causative organism, whetherit's, you know, you know, you
know, that there might be goingdown sepsis, you start
treatment, but then you want tofind the cause of uh, But on the
other hand, if, uh, if we have alow probability, it does a
(22:09):
testing, then, uh, perhaps youshouldn't be having to
administer all those bloodcultures and you should be, you
should, uh, be looking forsomething.
Meg Sinclair (22:18):
Back to that 42 percent that you mentioned of
doctors thinking it's sepsiswhen it's not, um, how does that
play into being good stewardsfor antibiotic stewardship and
fighting against antibioticresistance?
Dr. Rollie Carlson (22:31):
a very good question.
And it's one where, you know,antibiotic and the other thing
is E.
M.
S.
Is actually looking forcompliance to, uh, you know, um,
antibiotic utilization, youknow, as because I think as your
listeners probably are aware of,you know, the basically, uh,
resistant organisms have beenhospital, uh, are is a big, big
(22:54):
problem.
And quite frankly, um, it'santicipated the number of deaths
associated with, um, you know,and, you know, antibiotic
resistant organisms is going toexceed those of cancer deaths by
2050.
So this is something that verymuch needs to be, to be
addressed.
But I understand the situation,you know, the physicians are,
(23:16):
are certainly in, in that theydon't want to.
Uh, patients, they don't want tomiss a patient.
You know, if they believe it'ssepsis, their only recourse, I'm
not really sure, but my defaultis I'm just going to be able to
put them on antibiotics.
And I think that, and, and, andfrankly, it's up to us in the
biotech world to come up withsolutions to help them give them
(23:38):
the tools to provide thisselection criteria, you know,
uh, and these are busy people,you know, they're very, very
smart.
They know what they're doing,but they, they have.
If they have limited tools, uh,then they're going to stay with
what they do.
Meg Sinclair (23:55):
Yeah, to stay that conservative approach and
treats.
It's amazing work that you allare doing.
Um, looking ahead, what are yourfuture plans for future
developments or new innovationsin the field of sepsis
diagnostics or beyond?
Dr. Rollie Carlson (24:10):
Well, I think with sepsis, uh, with
sepsis, you know, faster.
Cheaper is very, you know,always, always useful.
Uh, our next generation productis set aside rapid B.
D.
Bacterial viral.
So in a single cartridge ofwhich we, uh, basically, you
know, in my hand, I'm holding,uh, I'm like a lab in my hand
(24:32):
here.
And this has got all thereagents, everything that's
necessary for extracting,purifying, uh, the, uh, um, the
genes and then find them andbeing able to have a, have a,
uh, report out and to that, forthe question that happens is
okay.
If sepsis in our test, by theway, so sepsis that could be
based on viral, okay.
(24:54):
As I said, the coven bacterialor fungal, and we just have
found for parasitology as well.
But the main drivers are backbacteria and viral.
And so there are tests thatwe're combining genes host
response genes that basicallyyou're saying if it's sepsis,
then is a bacterial or viral andyou'll have that same result at
(25:14):
the same time.
So that's what we're doing.
We're expanding also intopediatric indications.
And I think, you know, combiningthis with You know, direct
detection of pathogens in thefuture will be very, very,
Meg Sinclair (25:29):
I can't wait to see what y'all do next.
Well, Raleigh, our last questionis more of a fun one.
We like to ask each of ourguests if we ran into you at the
bookstore or at a local library,in what section would we find
you?
Dr. Rollie Carlson (25:44):
Well, you know, my PhD, I'm actually a
plant biochemist that, uh, that,that that focused on marine
biotoxins.
And so I love to dive.
I love the ocean.
I love anything above or belowthe ocean.
So you'll find me either in thesort of, uh, ocean,
(26:04):
oceanography, uh, certainly the,uh, the marine environment,
etcetera along those lines.
So, uh, and quite frankly, I Ilove geography.
I love history.
Uh, but my passion, you know,outside of, outside of what I do
for work is certainly wateroriented.
Meg Sinclair (26:25):
I'm a former ocean girl myself.
So I love the ocean too.
Yeah.
Well, it was great to have youon the show today.
Where can people go to learnmore and follow along and
connect with you, Raleigh?
Dr. Rollie Carlson (26:36):
Well, you can look up our product at
septicite.
com Uh, and certainly thecompany is immune express, uh,
com.
Meg Sinclair (26:47):
Terrific.
Thanks so much, Raleigh.
It was a pleasure.
Dr. Rollie Carlson (26:50):
Enjoy it, man.
Take care.
Meg Sinclair (26:52):
Thank you.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
(27:13):
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Welcome to another episode of From Lab to Launch by
Polyo, where we delve into thelatest innovations and insights
from the life science industry.
I'm Meg, your host, and todaywe're thrilled to have Dr.
Roland Carlson, the CEO ofImmunexpress with us.
Raleigh has been at theforefront of transforming sepsis
diagnosis.
It's a critical conditionresponsible for millions of
(00:39):
deaths and significant healthcare costs globally.
Rapid and accurate diagnosis isparamount, and Immune Express
has developed a diagnostic toolthat significantly enhances the
ability to differentiate sepsisfrom non infectious inflammation
within an hour.
Raleigh has over 25 years inbiotechnology, serving as CEO a
(01:00):
few times, and held key roles atAbbott Laboratories, and this is
Inc in molecular diagnostics andbusiness development.
You can see his full bio in theshow notes.
Septicite Rapid, supported byextensive clinical trials and
peer reviewed publications, hasreceived FDA 510k clearance, CE
(01:22):
marking, and approval from theAustralian Therapeutic Goods
Administration.
Welcome, Raleigh.
Dr. Rollie Carlson (01:29):
Matt, great to be here.
Thank you.
Meg Sinclair (01:31):
Thanks.
So you've been the CEO of ImmuneExpress for over six years.
Can you tell us briefly how yougot connected to the company and
what it was like leading throughCOVID?
Um, it was probably a disruptivetime for the business, as I
imagine.
Dr. Rollie Carlson (01:45):
As it was for everybody, I'm sure.
Yes.
Yeah, I, um, I joined thecompany actually, uh, after a
career at Abbott, as youmentioned, where I was head both
by, uh, Diagnostics andpharmaceutical responsibilities.
And I, I left Abbott to join theentrepreneurial world.
So, um, and I left for startupsin Austin, Texas, and we founded
(02:07):
a company called Assurgen, whichnow has been purchased by
Biotechni, and later a NasdaqCEO company for Wafergen
Biosciences, and now ImmuneExpress.
Um, I knew Immune Express as inmy company in Austin.
We had built a assay based upontheir novel gene markers for for
(02:30):
sepsis, and they wanted to havea system by which they could do
clinical testing for.
So I was introduced to thecompany that way, um, and, uh,
and after my stint at WaverGen,I was gainfully unemployed and
the board was looking for somechanges of leadership.
And so they asked me to be theadvisor and one thing led to
(02:50):
another.
I came on as CEO.
Meg Sinclair (02:53):
Stars aligned.
Dr. Rollie Carlson (02:54):
Yes.
Um,
Meg Sinclair (02:56):
yeah.
And what kind of challenges didyou all face during?
COVID.
Dr. Rollie Carlson (03:01):
Well, with COVID, I think, as we were in
the middle of our, uh, clinicaltrials associated with our, our
diagnostic, we developed aproduct and we were quite
bullish about, you know, from atime, you know, not only
fundraising, but then alsogetting FDA clearance and COVID
put a wrench in the works quitea bit.
Uh, not only did it slow down,obviously hospitals were, were,
(03:23):
you know, The front line wasCOVID management at that point
in time and doing clinical workwas not, um, that high in their
priority.
And so, um, however, we knewthat the test and we had
developed and did studies in,in, in Europe very quickly that
found that the test was veryusable for COVID induced sepsis,
(03:43):
you know, as, as a result, so Idelayed our clinical trials for
probably a good year.
And then also we filed for theFDA.
And of course, they were lookingat approvals for COVID products.
And so, um, that delayed us agood another nine months or so.
And so, but we were fortunate.
We were the first non COVIDproduct in infectious disease to
(04:06):
get cleared by the FDA, uh,coming out the other end.
And so, uh, we were very pleasedwith
Meg Sinclair (04:12):
that.
Lots of stars aligning on yourside there.
Right.
Uh, so septicite.
Rapid is a groundbreaking toolin sepsis diagnosis.
Can you share with us theinspiration and initial vision
behind the development?
Dr. Rollie Carlson (04:25):
Yes.
Well, sepsis is really aconundrum, you know, where it's
one of the leading causes ofdeath in hot U.
S.
Hospitals.
Uh, there's been someimprovement as far as mortality
and morbidity, but it's verydifficult to diagnose.
And so physicians actuallyrelying on pretty archaic, uh,
uh, technologies from 100 yearsago of doing blood cultures and
(04:47):
waiting for 24 or 48 hours tosee if they can get a result.
And many times they don't get aresult.
So, you know, physicians arereally challenged to have a
multitude of inputs and to tryto diagnose sepsis early.
It's easy to diagnose sepsis.
Uh, when it leads to, uh, organfailure and, uh, and somebody's
in dire, dire straits.
(05:08):
However, early detection ofsepsis is, is, is quite
difficult.
So therefore, there's a lot ofjudgment that physicians have as
a consequence of that.
So the vision of our, our, ourtechnology was to actually
develop a test that could berapidly diagnosed.
sepsis in the early stage and beable to intervene with the
(05:29):
appropriate patients who areseptic.
But many times, 42 percent ofthe time, physicians believe
it's sepsis, but it's not.
So both ruling in and ruling outsepsis is very, very important
because it could be these peopleare sick.
There's some other ideology.
They should be treated forsomething else, or they should
look for something.
So the way to do that, whichhistorically has been to look
(05:50):
for pathogens, requires a numberof copy numbers of a bacteria or
virus or path or fungus to grow.
And what we were measuring andwe found that the human, uh,
substance is reallydysregulated, uh, systemic
inflammatory response syndromeas a result to a pathogen
(06:11):
infection.
And what that starts is your,your, your, your body is
actually hyper immuno reactingto the pathogen.
And it's really that hyperimmune response that actually
leads to cascade and ultimately,you know, high morbidity or more
mortality.
And so what it was important todo.
There's systemic inflammatoryresponse with no pathogen.
(06:33):
It's ephemeral.
If you were in a car accident oryou had chronic pancreatitis,
you might have symptoms ofsystemic inflammatory response.
And what we developed wasactually measuring the human
response from like blood cellswith a highly sensitive M.
R.
N.
A.
QPCR test that measuresdifferential expression of these
(06:54):
genes.
And these genes, what they'reable to do is, uh, on some in
the presence of a pathogen orhighly upregulated.
And the other one is not.
And then if there's not apathogen, then the one gene is
quite stable.
And the other one is actually,uh, lower expressed.
So we can measure it.
(07:15):
Uh, the algorithm, uh, and thatspits out a score of the
probability of sepsis from highto low.
Meg Sinclair (07:23):
Great.
And how is the speed importanthere with this new testing
compared to the old archaicmethods?
Dr. Rollie Carlson (07:29):
Well, um, the, it's pretty well known that
if somebody does have sepsis,uh, as each hour goes by, the
increased probability ofmortality goes up by 8%.
So if you're waiting for 12hours or so, yeah, obviously
that's a problem.
And so, uh, it was importantwhen we did our market research
is that you needed to have atest.
(07:51):
And the test, by the way, that Ioriginally, uh, developed in my
former company for the forimmune express was on a
conventional molecular platform,which was a plate based one,
which would take about 8 to 12hours.
And they were looking atretrospectively what was the
diagnosis and found a highcorrelation.
But for, from a marketabilitystandpoint, you really had to
(08:12):
have something that could Have aresult within one to two hours.
And so that was part of ourdesign goals for the test that
we have, uh, such a site rapid,uh, which is a sample to answer,
um, uh, product and, uh, veryeasy to use.
And we can have a turnaroundtime in one hour.
Meg Sinclair (08:32):
That's a big difference from eight hours.
Dr. Rollie Carlson (08:34):
Absolutely.
That's
Meg Sinclair (08:35):
such an improvement in patient outcomes,
I can imagine.
Dr. Rollie Carlson (08:39):
Indeed.
Indeed.
Meg Sinclair (08:42):
What else, um, with the subcyte rapid
performance compares to otherbiomarkers that you can share
with us?
Dr. Rollie Carlson (08:51):
Well, there's a number of, there's a
number of biomarkers and there'sother sort of symptomology, you
know, that, uh, that.
In clinical, clinical signs thatthat physicians look at.
And in sepsis it's probablyabout 12, uh, 12 of them, you
know, it'd be fever, high blood,white blood count, uh, uh, low
(09:11):
lactate levels.
Lactate is is something that'sused that's more about, uh,
perfusion and make sure that youhave the appropriate sort of
fluids associated with that.
Um, and other biomarkers arenonspecific.
In other words, there's there'ssome procalcitonin, which is
actually a a a marker that isvery specific for bacterial
(09:36):
infection and is not used.
It's used indirectly for sepsisdetection, but Uh, it's it's
labeled for actually withdrawalof antibiotics.
If somebody is responding tothat, uh, CRP is also used in
some occasions.
But what they have to do isreally take all of those
(09:56):
together and be able to come upwith a result.
And in our clinical trials, whatwe did was we looked at our
septus score result, which isthe result that we get from our
test compared to all those othervariables.
And it was Uh, well, well, whenyou combine those variables
together, then you get a, uh, animproved performance.
(10:16):
The CEPA score alone, uh, wasactually superior to all those
combined.
Um, so, um, instead of aphysician having to do a
multifactorial in their head ofthose 12 different things, then
they should be able to have thatscore.
Now, You know, you do need tolook at those other variables
because every, every, uh, everypatient has sort of a unique
(10:38):
situation.
And so, um, but, and so what welook at is if there's two sides
of that systemic inflammatoryresponse, uh, and, and physician
is suspicious of sepsis, thenyou should do a blood draw, um,
and which normally they would dofor cultures.
At the same time, they should dothis for cultures.
our test.
And what we found was that, youknow, within an hour, you could
(11:01):
have the result with a very highcorrelation.
If it led to a positive bloodculture, we had a very high,
probably high correlation withblood cultures.
But we have that result withinan hour where you had to wait
for 24 hours for the blood test.
Meg Sinclair (11:18):
And time is of the essence with sepsis.
So that's amazing.
Well, we talked a little bitabout your challenges with
COVID.
What are some of the mostsignificant challenges you faced
in the development and clinicalvalidation of septicide rapid?
Dr. Rollie Carlson (11:33):
Well, in my career, and I'm sure that, you
know, your, your listeners, aswell.
If you're looking at a productthat's, um, you're trying to
develop and, and you're actuallylooking at something that is
maybe a better mousetrap, maybeit's faster, cheaper, whatever
for an existing, the existingproduct, the, uh, what I'll call
the product market fit is, ispretty well defined.
(11:56):
Okay.
So, uh, if you have a betteroncology test, something that's
faster, You know, for EGFR, KRAS or something along those
lines are easier to handle.
So that, that is fairlystraightforward.
But when you get to a, aproduct, which is, which is in a
space that is novel and, andthere isn't a fixed application,
(12:17):
then that product market fit isvery important to understand
early in the process, uh,because, You can go down and
think, you know, internallybelieve that, you know, this is
the best thing since slicedbread.
But as a matter of fact, are youreally fulfilling a customer
need?
So you have to do the marketresearch up front.
You need to make sure that yourdesign goals fit that.
(12:40):
And you have to be pretty rigidabout that.
Is, is, do you meet those ornot?
For example, if we were tryingto develop a subsite rapid and,
um, it took three hours insteadof one hour.
Then you know what?
We usually go back to thedrawing board.
Don't try to go out with threehour test, you know, uh, in in
that regard.
And then the other thing is,it's a do the market research up
(13:03):
front.
And then, uh, and and I thinkthat as you're doing In the IBD
world in diagnostics, it'sdifferent than what you're doing
for a CLIA test, for sure.
Uh, you need to be able to lockdown what the specifications are
for getting FDA clearance anduh, other, other clearances.
And many times, companies,because of the rush to try to
(13:26):
get the product out, will lockdown those design goals.
Too early, and then they getdown the process and, uh, they
might find thatmanufacturability is a problem.
Things along those lines.
Mm-Hmm.
So, um, my philosophy, whichI've learned the hard way, is
stay in phys feasibility as longas you can to make sure that
you've asked the hard questionsthat you're able to over, you
(13:49):
know, achieve as far as those,those goals are concerned.
And then actually it's very easyto go through that design
process.
Meg Sinclair (13:58):
Great advice.
Speaking of your 510k clearanceand CE marking, you've also
gotten the AustralianTherapeutics Goods
Administration approval.
That's quite the regulatory, um,quality achievements and quality
management is at the heart ofwhat we do here at Qualio, so
have to ask, um, how doesImmunexpress ensure the
reliability and accuracy of yourproducts and instill a quality
(14:20):
of culture?
Dr. Rollie Carlson (14:23):
Well, I think that number one, I mean,
if you're in this business, youhave to aspire to have the
highest quality to fulfill yourcustomers.
And we're talking about serious,you know, medical devices and
diagnoses, and you have toensure that you're providing
your customers and yourpatients, you know, quite
frankly, the highest qualityproduct.
Um, I had the benefit of Oflearning within the Abbott
(14:48):
system, so to speak, you knowthat you needed to really have
being lockstep with qualityquality regulatory early on in
the process, and particularlyfor founders.
And I've worked with founderswho had That it might, for
example, the company in Austinthat I joined, the co founder
there was, you know, a fantasticscientist and very successful in
(15:11):
the life science world and hadnever done anything in the
quality regulatory sort of, uh,and the appreciation of that,
you know, one tends to discountif you haven't gone through
that, but that can come backclearly to, uh, be, be an issue.
So, uh, engaging quality andregulatory, which I, You know,
as as key members of the team,not just something that you sort
(15:33):
of throw over the wall.
You can't do that to besuccessful, you know, in that
regard.
And I've been very proud of theteam that we have, you know, in
achieving the accomplishmentswe've had.
We have at the Express, they'reexperience both domestically and
internationally.
And, you know, if you work withthe agencies up front too, um,
(15:57):
and making sure that you, insome cases, and particularly in
this situation where you have anovel product like Ceptoside
Rapid, you need to go throughand engage the agency early on
and saying, this is what we'replanning on doing.
Do you have the input before wespend, you know, millions of
dollars on clinical trials, etcetera.
Meg Sinclair (16:17):
Yeah, great advice.
Those early FDA meetings arealways worth having, especially
with those novel devices to, toknow where you need to chart
your map.
Dr. Rollie Carlson (16:26):
Indeed.
And sometimes you get feedbackthat you don't, you really don't
want to hear, but it's veryimportant to get that early on
because if you spend, you know,uh, your investors money and you
have expectations for clearancesand, and you have a, um, a
hiccup.
And I think there's someexperiences, you know, fairly
recently with companies wherethey went all the way down the
(16:47):
path and they couldn't get FDAclearance.
And that obviously, uh,
Meg Sinclair (16:53):
Yeah, too late to pivot at that point.
So exactly.
How does stuff to say rapid testintegrate with current clinical
workflows in hospitals and whatfeedback have you received thus
far from healthcare providers?
Dr. Rollie Carlson (17:08):
Well, what we found with sepsis, and not
only in Europe and the U.
S., it's, it's managed verydifferently by different
institutions, uh, but, and, andthere's many sort of
stakeholders associated withsepsis management.
If you're trying to be able toidentify sepsis in the emergency
(17:28):
room, uh, department, then whatyou're trying to do is, you you
know, quickly rule in, rule outin that.
Um, our test is really not forscreening, you know, a patient
who might come in with a feverand and looks a little a little
sick or so.
It's really somebody that'sstrong, especially suspected of
being sepsis.
And you know what?
(17:50):
The different stakeholdersassociated with sepsis
management are going to be, uh,critical care, uh, patients.
doctors, nurses, E.
D.
Doc.
That's going to be doing theadmissions.
And then ultimately, um, youknow, the infectious disease,
uh, doctor that after patient isis admitted.
And what happens is initiallythere's gonna be an order set.
(18:12):
Different hospitals will say, ifI suspect, uh, that there's
going to be a patient ofsubstance, they'll say, I want
to, uh, uh, draw blood forlactates for a look at, uh, WBC,
white blood cell counts.
Uh, and they call these things,uh, sepsis bundles, and there
(18:32):
are sort of three or four keycriteria, um, by which they're
going to react to.
And the, uh, there are, thereare international guidelines
associated with that, uh, butthey're, you know, they are not
something that everybodyfollows.
Um, in the U.
S.
C.
M.
S.
Has actually, uh, been prettyprescriptive as far as what they
(18:55):
call, uh, set one bundles whereif you suspect somebody to have,
uh, substance, you need toeither you need to either
administer antibiotics and treatthem within three hours or not.
And you need to know one.
Is there an infection?
And two, is there is a systemicinflammatory response, which is
exactly what our test does.
(19:16):
So as we what we're doing iswe're when we approach
customers.
What one?
What is what are you doing forsepsis?
Uh, to what is your need?
Because in some cases, you know,it's the inpatient sepsis.
That's their biggest problem.
They got their process foradmitting etcetera like that
into.
(19:36):
But when a patient ends up inthe hospital, then what?
What?
What happens?
And to them and in other cases,we have too many people coming
through the E.
D.
We can't answer that.
We can't triage them fastenough.
So we want to be able to bucketthem.
You know, that's, that'sassociated with it.
So we, we try to, uh, and many,um, hospitals want to do an
(20:00):
evaluation.
I mean, for us, it's importantto do an evaluation to try to
meet their unmet, their unmetneed.
Right.
So that's, that's, that's ourapproach, right?
I think that we, our test reallyhelps drive compliance to, uh,
uh, the CMS, uh, substancebundles, you know, and I think
(20:20):
there's a good recognition from,um, uh, from hospitals
associated with that.
Um, and I think that as we haveused the test is being used,
there's some interesting youknow, results.
First off, I made that commentabout 42 percent of the time
(20:41):
physician thinks it's sepsis.
It's not so that's beingverified.
And so, uh, major customers aresaying, Wow, we're really
surprised how many people wethought had such a stone, you
know.
But then, on the other hand, Uh,there's, they're saying, wow,
you guys really highly correlatewith blood culture if it's
positive and we're ruling inanother use case would be post
(21:05):
surgery.
If you have patients that arehaving having surgery, there'll
be the surgical ICU.
There's a lot of concern aboutinfection.
Um, and and can they be reallydischarged to the ward for for
recovery and looking at our testas far as ruling rule out is
(21:25):
important.
And if they if our test ispositive, and I'm not sure if
your listeners are aware, butright now there's a blood
culture bottle shortage rightnow that the FDA has put out
notice for.
Um, and the blood cultureindustry is still very, very
large.
Um, but right now there's ashortage of that.
And what we found was, is thatwith our test for positive,
(21:49):
actually, you would like todouble up your blood cultures,
uh, causative organism, whetherit's, you know, you know, you
know, that there might be goingdown sepsis, you start
treatment, but then you want tofind the cause of uh, But on the
other hand, if, uh, if we have alow probability, it does a
(22:09):
testing, then, uh, perhaps youshouldn't be having to
administer all those bloodcultures and you should be, you
should, uh, be looking forsomething.
Meg Sinclair (22:18):
Back to that 42 percent that you mentioned of
doctors thinking it's sepsiswhen it's not, um, how does that
play into being good stewardsfor antibiotic stewardship and
fighting against antibioticresistance?
Dr. Rollie Carlson (22:31):
a very good question.
And it's one where, you know,antibiotic and the other thing
is E.
M.
S.
Is actually looking forcompliance to, uh, you know, um,
antibiotic utilization, youknow, as because I think as your
listeners probably are aware of,you know, the basically, uh,
resistant organisms have beenhospital, uh, are is a big, big
(22:54):
problem.
And quite frankly, um, it'santicipated the number of deaths
associated with, um, you know,and, you know, antibiotic
resistant organisms is going toexceed those of cancer deaths by
2050.
So this is something that verymuch needs to be, to be
addressed.
But I understand the situation,you know, the physicians are,
(23:16):
are certainly in, in that theydon't want to.
Uh, patients, they don't want tomiss a patient.
You know, if they believe it'ssepsis, their only recourse, I'm
not really sure, but my defaultis I'm just going to be able to
put them on antibiotics.
And I think that, and, and, andfrankly, it's up to us in the
biotech world to come up withsolutions to help them give them
(23:38):
the tools to provide thisselection criteria, you know,
uh, and these are busy people,you know, they're very, very
smart.
They know what they're doing,but they, they have.
If they have limited tools, uh,then they're going to stay with
what they do.
Meg Sinclair (23:55):
Yeah, to stay that conservative approach and
treats.
It's amazing work that you allare doing.
Um, looking ahead, what are yourfuture plans for future
developments or new innovationsin the field of sepsis
diagnostics or beyond?
Dr. Rollie Carlson (24:10):
Well, I think with sepsis, uh, with
sepsis, you know, faster.
Cheaper is very, you know,always, always useful.
Uh, our next generation productis set aside rapid B.
D.
Bacterial viral.
So in a single cartridge ofwhich we, uh, basically, you
know, in my hand, I'm holding,uh, I'm like a lab in my hand
(24:32):
here.
And this has got all thereagents, everything that's
necessary for extracting,purifying, uh, the, uh, um, the
genes and then find them andbeing able to have a, have a,
uh, report out and to that, forthe question that happens is
okay.
If sepsis in our test, by theway, so sepsis that could be
based on viral, okay.
(24:54):
As I said, the coven bacterialor fungal, and we just have
found for parasitology as well.
But the main drivers are backbacteria and viral.
And so there are tests thatwe're combining genes host
response genes that basicallyyou're saying if it's sepsis,
then is a bacterial or viral andyou'll have that same result at
(25:14):
the same time.
So that's what we're doing.
We're expanding also intopediatric indications.
And I think, you know, combiningthis with You know, direct
detection of pathogens in thefuture will be very, very,
Meg Sinclair (25:29):
I can't wait to see what y'all do next.
Well, Raleigh, our last questionis more of a fun one.
We like to ask each of ourguests if we ran into you at the
bookstore or at a local library,in what section would we find
you?
Dr. Rollie Carlson (25:44):
Well, you know, my PhD, I'm actually a
plant biochemist that, uh, that,that that focused on marine
biotoxins.
And so I love to dive.
I love the ocean.
I love anything above or belowthe ocean.
So you'll find me either in thesort of, uh, ocean,
(26:04):
oceanography, uh, certainly the,uh, the marine environment,
etcetera along those lines.
So, uh, and quite frankly, I Ilove geography.
I love history.
Uh, but my passion, you know,outside of, outside of what I do
for work is certainly wateroriented.
Meg Sinclair (26:25):
I'm a former ocean girl myself.
So I love the ocean too.
Yeah.
Well, it was great to have youon the show today.
Where can people go to learnmore and follow along and
connect with you, Raleigh?
Dr. Rollie Carlson (26:36):
Well, you can look up our product at
septicite.
com Uh, and certainly thecompany is immune express, uh,
com.
Meg Sinclair (26:47):
Terrific.
Thanks so much, Raleigh.
It was a pleasure.
Dr. Rollie Carlson (26:50):
Enjoy it, man.
Take care.
Meg Sinclair (26:52):
Thank you.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
(27:13):
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
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