Intro 0:03
Welcome to Maximal Being, a podcast devoted to ditching fad diets and using real science to get you healthy and feeling great. I’m Doc Mok, a GI and functional medicine doctor who harnesses the power of gut health to get you achieving your goals. And I'm Jacky P, a well-informed layman who challenges the experts and ask the questions that you want. Don't forget to hit the subscribe button or leave a comment, and now onto the show.
Doc Mok 0:32
What's going on Maximal Beings, Doc Mok here with maximalbeing.com. Don't forget to hit the subscribe button. Leave us a comment, it does help us to get the word out. If you have any questions, you can email us at [email protected]. Enjoy the episode.
Hello, hello, hello, Maximal Beings. It's me, Doc Mok. Jacky P is going to be beaming on, unfortunately, he had a significant loss in his life today, and that is his cell phone. We know how difficult that could be in life, so he's figuring that out, but I'm standing in. Hopefully it won't get too nerdy today. Joining me on the podcast is Erica Barnell, who is fascinating in terms of her story, and I'm super excited to see what Geneoscopy has to offer for our patients with Crohn's and Ulcerative Colitis. For those of you listening for the first time, don't forget to hit the subscribe button. Leave us a comment. Really does help us to get the the word out. Leave those five star reviews, and I'm Doc Mok. I'm a therapeutic endoscopist by training, so that's a fancy type of GI doctor that manages, treats, diagnosis GI cancers, and I'm also boarded in functional medicine. And joining me today is Erica Barnell, welcome Erica.
Dr. Erica Barnell 1:47
Thank you so much for having me. I will say this will get nerdy, so get ready. Very excited for it.
Doc Mok 1:54
Watch out. Yeah. Strap on your pocket protectors, everybody. Erica, you know, we always start the podcast off with just, you know, getting to know our guests. And I think that's really helpful for our audience to relate to you and and understand why you got into the world of stool RNA testing and inflammatory bowel disease in particular. So tell us your superhero origin story.
Dr. Erica Barnell 2:17
Absolutely, you know. I mean, doesn't every little girl you know want to grow up and be a research scientist that tests poop for a living? I think that's a really common goal for young girls.
Doc Mok 2:32
Maybe they should.
Dr. Erica Barnell 2:35
No, I, I had no idea kind of where I wanted to be when I was growing up, but I definitely knew I wanted to be in science. I definitely knew I wanted to be in healthcare. And so as I kind of went through that education process, I went to Cornell, and I double majored in biological sciences and the business program there. And when I thought about my higher education, I matriculated to the MD PhD program at WashU in St Louis with the hopes of of combining some of my entrepreneurial spirit with some of the research that that I had been doing as an undergrad. And so at the time, in 2014 when I started that program, I had been doing a lot of research in the microbiome labs at WashU, and specifically we were looking at non-specific gut inflammation that afflicts children in Africa and Asia. So it kind of looks like Crohn's disease or IBD, but it's caused by bad access to, you know, water that that might be contaminated, or foods that might be contaminated, lack of health care. And it's it's asymptomatic, and it afflicts children, and it causes growth faltering. So by the time children are about five, they start to be stunted relative to their peers. So as an undergrad, I was basically tasked with trying to figure out what causes this disease, trying to figure out which kids had the disease, how bad it was, and then provide interventions to alleviate that growth faltering. And you know, when you think about kids in Africa and Asia and rural villages, you know, I can't ask for scouts. I can't get blood, typically, I can't get all the normal things that we come accustomed to here in the United States. And so we just had the mom send us diapers, and we were really successful at pulling out the cells from the diapers that are coming from the intestines, the large and small bowel, and dictating disease in those cells, figuring out which kids had it, and figuring out why they had it, and providing antibiotics or changing their diet or changing their environment to alleviate that growth faltering. So when I started the MD PhD program, I said, wow, this is really cool technology. You know, maybe I can apply it to some of the things I'm seeing in the clinic that we have here in the United States, like colon cancer and Crohn's and Ulcerative Colitis and IBS and my PI my principal investigator, investigator said, yeah, you could totally do that, but, you know, I don't really have much interest. So I pulled the technology out of the university, and I founded Geneoscopy to explore how, how this technology could be used, first for colorectal cancer screening and and now we, we've moved on to IBD, monitoring mucosal healing and predicting therapeutic response.
Doc Mok 5:48
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Can you just go one step further and break down for the audience what a principal investigator is when you're going through training, I mean, and maybe talk about your relationship with this person in terms like, you know, clinically, professionally?
Dr. Erica Barnell 8:34
Absolutely, I think. You know, it's so important for everyone, really, to have mentors. And when you're a physician scientist, or just a scientist at all, a principal investigator really helps you understand the research that you want to do, the skills that you want to develop, develop in the laboratory, and where you ultimately want your career to go. So they're really just a mentor that helps you kind of build the skills you need to become the best scientist that you can.
Doc Mok 9:11
That was such a great explanation. I really appreciate that. And I can just imagine like so you're, you're getting these stool samples, and what sort of resources did you have available to you? You know, with these people struggling in a different country, so talk to me about that.
Dr. Erica Barnell 9:28
Yeah, it's, it's, it's so dichotomous, right? I as an undergrad, I was sitting in this laboratory with every instrument imaginable, you know, every resource at my disposal, negative 80 degree freezers, centrifuges, sequencers, you know, just, just the top
Doc Mok 9:49
Millions and millions of dollars
Dr. Erica Barnell 9:50
Millions of dollars. WashU in particular, is just an unbelievable institution. I feel so grateful to have access to those resources. But I. Um, you know, switching your mindset to think, Okay, how do I deliver healthcare to patients in rural Africa? How do I diagnose disease for those individuals? How do I provide interventions that are reasonable, that are cost effective, that don't need a cold chain, you know, putting that mindset on to kind of transition between doing research in a really sophisticated lab and then providing intervention for patients and making sure that those patients can be compliant with what you're recommending - is it's not only important in rural Africa, you know, that's something that's important in the United States in general, there are so many health disparities that exist. There's so much distrust with the healthcare system, and being able to reach your your patients where they are is just so important.
Doc Mok 10:55
Well said. So you know, you start evaluating these stool studies, and you start to lean towards colon cancer, but obviously there's a lot of similar sort of testing on the market, and we've talked about that before on this podcast in particular, like the big name brands that have been out there who look at first blood and then maybe some DNA. Can you talk to the audience about what makes yours so special, and the difference between DNA and RNA testing?
Dr. Erica Barnell 11:25
Yeah, so I think, you know, we had this amazing technology that we pulled out of the university. We had this company. We were three really motivated students who wanted to solve some big problems in healthcare, and the first thing we thought about was, where do we start? And you know, at the time, I mentioned that I was rotating on my clerkships, and I was being introduced to the hospital, and so I met a woman who was diagnosed with stage four colorectal cancer who had foregone a colonoscopy because it was difficult for her to take time off work, and it was just really distressing to see somebody who did not have options beyond, you know, colonoscopy, which was invented 50 plus years ago, especially in an era where we can sequence the human genome in 48 hours, and we can provide non-invasive technology to patients' homes. So, you know, I recognize that as a massive need, and felt that the technology that we had developed, which was RNA biomarkers and stool samples, would be primed to address that healthcare gap. So we did start with building a diagnostic to screen for colorectal cancer, with the hypothesis that RNA biomarkers would be very good at detecting both colorectal cancer and precancerous lesions that could actually prevent the development of colorectal cancer. So we've gone through that process of building that diagnostic from the idea to feasibility to concept to design lock, and then we actually received FDA approval for the first RNA based diagnostic test to screen average risk individuals, 45 and older, for colorectal cancer in May of of this year. Very exciting.
Doc Mok 13:24
Congratulations. That. And for the listeners out there that have never gone through the FDA process, it is exceptionally rigorous, very difficult to go through. Obviously, there's a reason for that, but congratulations on making it through all of those hurdles.
Dr. Erica Barnell 13:39
Thank you. I, you know, the agency is is a bear, but they're just, you know, scientists like me doing their job, and it was a great process, but yes, it took eight years and a lot of work by a lot of very talented people at Geneoscopy. And so I think, you know, it was a massive milestone for us to validate that RNA biomarkers could be leveraged to diagnose disease in gastrointestinal health. And so that's when I, you know, no rest for the weary. I thought it'd be interesting to explore other things in GI health and maybe get back to my inflammatory roots, and so I refocused to start looking at IBD, and I think that's an area of massive unmet need in the GI community. I knew it would be a little bit more difficult than building a diagnostic for colorectal cancer screening, just because of the complex nature of of the pathogenesis of that disease, but we're very ready for that challenge and really excited to start thinking about how we can leverage Geneoscopy's platform to help those patients.
Doc Mok 14:51
Thanks for that. And you know, I always thought of like DNA is, you know, you want to bake a cake so you go online and you find a recipe on somewhere. I always think about that as the recipe. But then the dough that you make is the RNA, so that dough can be different based upon the quality of the ingredients that you have, your interpretation of the DNA. And then the final product, the cake, is like the protein structures and things that are made. So there's a lot of different things that can occur. And for the listeners out there that aren't medical when we're testing a lot of people for genetic conditions like braca, etc. Now the tests that we use are primarily actually RNA based, because we found that it just expands the diagnostic utility of these very delicate conditions. So I've always viewed it as way more specific, you know, like, way more positive, if it's positive. So do you see it the same way? Is that why you picked RNA?
Dr. Erica Barnell 15:52
I think in general, science, scientists and physicians have viewed RNA as like you're describing, more dynamic. It's more reflective of what's happening in the cell. It can be exponentially amplified or exponentially down regulated as a response to a single change in the DNA, which is billions of base pairs long. And so I think it's always been recognized as something that had a tremendous amount of value. The biggest issue has been stabilizing RNA and measuring it, quantifying it reliably, and so I think that's where a lot of the technology that we developed lies, is being able to query these very informative biomarkers with high reliability.
Doc Mok 16:45
Yeah, and, I mean, a lot of people think that gastroenterologists are at odds with people like you in the colon cancer space. Number one, we're not. None of us are starving for business out there. We're all just drowning in business. And in my mind, there's just a certain percentage of population, mostly men, honestly, that are just like ew a colonoscopy, but it gets those people to do something to screen for polyps, colon cancer, and if positive, then we do a colonoscopy, and often we'll find something that we can get rid of and mitigate the risk of colon cancer. And that's why, although colon cancer remains on the rise, although the age of diagnosis is going down, it's still the second leading cause of cancer death in America, but it's still very preventable, you know, and and getting more people tested is absolutely the answer, because we found that, because it's such a slow growing cancer, that testing really works.
Dr. Erica Barnell 17:48
No, Dr Mok, you're you're so right. Um, every single GI that I've talked to has been really excited about what we're doing. You know, people don't recognize that colonoscopies are a valuable resource that we as a country have, and we have to leverage it in a way to most effectively treat a huge population. And I think you know the number of GI docs are not growing. If all of you, no, not enough of you for sure, and if all of you are working around the clock, which most of you are, and scoping, you know, dusk to dawn to dusk, we don't have enough colonoscopies to service the 150 million Americans that need colorectal cancer screening, let alone the millions of Americans that need multiple scopes a year because they have Crohn's disease or strictures or any gastrointestinal distress or GI bleeding or other diagnostic requirements. And so I think what we're proposing is a solution to that backlog. Is a solution to the increase in required screening by dropping the age of recommended screening from 50 to 45 by the USPSTF, what we're providing a solution to GI docs, where we can just fill their docket with adenomas and cancers, which is what they love doing anyways, right? Who wants to scope a normal colon? That's that's not fun
Doc Mok 19:25
Right.
Dr. Erica Barnell 19:27
And so,
Doc Mok 19:27
Although some days I'm like, yeah,
Dr. Erica Barnell 19:33
When you got 90
Doc Mok 19:35
Yeah
Dr. Erica Barnell 19:35
Tortuous colon, yeah, no, that's fair, um. But what I would say is, is most Gastroenterologists recognize at this point the value in non-invasive screening and recognize where, where the field is headed, especially as we're able to increase the sensitivity and specificity of non-invasive tests to ensure that we're not missing cancers. You know, we're not missing high grade dysplasia. And we're making sure that the patients that come back negative are negative.
Doc Mok 20:04
Yeah, and that's a good point. And then we'll get to inflammatory bowel disease. But you know, some of the issues that I've had with some of the most commonly used technologies are that on the commercials, they say it detects 92% of colon cancers. But in the new New England Journal of Medicine paper that led to its use, it misses 8% of colon cancers. That is a lot. If you're that 8 out of 100 people. If I'm that 8 out of 100 people, I'm worried. So I always counsel patients about that that like, I miss, to my knowledge, 0% of colon cancers. But when that test is negative, you may.. what's my ADR is 50 to 60% actually, yeah, which is yeah, thank you. Yeah, the national average is around 25% and I'm not bragging, and I and I have also a very weird practice, yeah, I'm at, I'm at a cancer center, right? So we see different stuff than other people. But, you know, I think, I think that just having something that maybe has a slightly higher ability to say that colon cancers accurately is really, really important.
Dr. Erica Barnell 21:24
Yeah, and I think, you know, when we talk about our sensitivity and specificity, it's in the context of a clinical trial that was run on patients that received our test and a colonoscopy. You know, ultimately, my goal is not to get a patient to do a colon sense test that would otherwise get a colonoscopy. You know, right now, our compliance rate for colonoscopy is somewhere between 50 and 60% which means that if you know, 150 million patients are eligible for colorectal cancer screening. 10s of millions of patients are not up to date with colorectal cancer screening guidelines. So when I like to think about my sensitivity and specificity, especially if we're trying to engage patients that are currently non compliant with recommended screening guidelines. I'm not comparing my accuracy profile to colonoscopy, right? I'm comparing my accuracy profile to no screening, which I can do a heck of a lot better there. And I think it's it's really exciting. It would be really exciting for me to look at the population of people that we're seeing as we launch commercially and trying to serve the individuals that are again, not yet engaging with colorectal cancer screening, or live in underserved populations that would otherwise not be able to get a colonoscopy.
Doc Mok 23:00
That's really great. And that like echoes your mission of how you came to get to where you are too, which is really wonderful.
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But switching gears to a really interesting patient population, IBD or inflammatory bowel disease, which, for the listeners out there, I encourage you to listen back to our episode with Mo Naem and Dr Susan Kais, we go through inflammatory bowel disease. We go through a lot of the nutritional interventions. And Dr Susan Kais, who's a friend here in Florida, that's kind of her area of expertise, and she does it much better than I ever could admit. But for the listeners out there listening for the first time, Crohn's disease is one type of IBD, ulcerative colitis is the other type. Erica, do you want to go through like you know, some of the nuances of both of those conditions with the listeners out there?
Dr. Erica Barnell 25:43
Sure. So they both fall under the bracket of inflammatory bowel disease. They're kind of two sides of the same coin. They have different demographics, they have different ages of onset. They have different disease pathways, but for the most part, they both consist of non-specific gut inflammation that is typically caused by dysregulation of your immune system. For Crohn's disease, it can really be anywhere in the GI tract. For ulcerative colitis, it's typically contained within the large bowel, and that is, you know, a disease that is not only chronic, which means that it's, it's, you know, once you're diagnosed, it's for the rest of your life, but typically it has a relapsing and remitting course, so that you can experience flares. You can experience times where you're unbelievably uncomfortable and miserable, and the drugs that you had been taking for 10 years that controlled it really effectively are no longer working, and nobody really knows why. It can be incredibly debilitating for patients. And a lot of patients spend time, you know, visit the hospital and know their GI physicians and their docs really well. And this disease can afflict children, especially Crohn's disease, can have an early age of onset, you know, even under 12 years old. So when I think about, you know, what I was doing when I was 12, which is, you know, playing with my brother in the backyard. Um, it's very different than than a picture of a pediatric Crohn's patient who might be experiencing surgical resections of of their small bowel because of strictures. So it's a really, truly awful disease that I hope we we can address with better diagnostics and monitoring with our tests
Doc Mok 27:41
That's really well put, I think, in terms of medicine, they're one of the most unique patient populations because they're so young and they're so sick, and they're so sick for so long, and they're going to be sick, most of them for forever, and the all of the things that come with that. You know, having a low level of inflammation in your body over time is not great for your health for so many reasons, not just the physiologic reasons that we learned in medical school of nutrient absorption and protein intake and all that, but just the psychologically, I mean, a lot of them have gone through such trauma and have anxiety and depression and they can't exercise and they can't hold down a job or relationship, their fertility issues that pop up with IBD patients. So they're just such a unique, difficult patient. And as gastroenterologist, I feel lucky that we have an ability to kind of care for that unique patient population.
Dr. Erica Barnell 28:46
And I definitely think, like you're describing that, you know, it's a combination of your environment and genetics and your ability to access health care and make sure that your insurance is, you know, paying for the medications that work, instead of continuously trying to put you on generics that we know don't work. So that can always be a struggle. But I do feel confident that that we're in a better place now than we've ever been with IBD, which is really exciting, and it's it's kind of in a place today where we were with cancer 20 years ago, where we're starting to have, you know, a huge variety of of drugs, of very specific, targeted therapeutics that can address a unique individual case. And I think where we want to be is allocating patients to a certain therapeutic or a certain mechanism of action that we know is efficacious, rather than trying to make them go through the gauntlet of of different therapies that that might not work. And again, I think that's where we were in oncology 20 years ago, with Foundation Medicine and with the advent of immunotherapies and with targeted therapies. And so I really, I'm really excited to be a part of that, that healthcare program moving forward.
Doc Mok 30:07
Yeah, I mean, I always equate it to oncology care, to your cancer care. You know, you're giving infusions, you're giving injections, you're checking levels, you have all these pre tests before you start therapy, but it's, it's still just so challenging to diagnose. In some people, you know, the gold standard, right, is to do a colonoscopy, like we mentioned, which is a limited resource. And some of these, you know, I don't take care of pediatric patients, but in a pediatric patient, it's hard. It's even harder to get an endoscopic procedure. And when we do a colonoscopy, we're looking at the colon. And Crohn's disease doesn't always affect the colon, so you may not actually be looking there. And we can do things like pill capsules, which is like this little pill you swallow, it takes thousands of pictures per second and travels through the small bowel. You can't do that in a lot of Crohn's people. We can do imaging that may infer something, but infection looks the same as Crohn's sometimes. So it's so, still so hard to diagnose. So talk to me about, you know what, what your team has developed to add to our ability to diagnose this very tough condition.
Dr. Erica Barnell 31:19
Absolutely. And I think this is another reason why I think is RNA is so powerful when you're thinking about autoimmune or inflammatory conditions, you know, except for predisposition, there aren't really any DNA changes that you would be looking for, right? What you really need to be measuring is the inflammation, the extent of inflammation, the mucosal barrier, you know, the breakdown of of the microbiome, or the changes in the microbiome, and and I think that's where RNA can play a massive role in terms of what you're describing, which is diagnosis of disease. And then subsequently, once a patient has been diagnosed, monitoring the disease to make sure it's it's in check, and then predicting therapeutic response, so making sure the patient's on a therapy that's addressing the mechanism of action of this disease. And so I think across those three indications, diagnosis, monitoring, mucosal healing and predicting therapeutic response, you know, Geneoscopy's technology can be leveraged for all three of those types of diagnostic tests.
Doc Mok 32:28
It's, it's really complicated. So, I mean, you know, now that we have this huge gamut of medications that we can give to people, I know you just presented at the Crohn's Colitis Foundation America meeting about your your data, but you just share some of that, how you're able to find markers that predict potential response to the therapy. I mean, that's like, huge to determine an individualized medicine versus, like, whatever the person knows about, whatever the insurance will approve, like, this is a really valuable thing for, like, individualized medicine, which really is the future. Let's face it,
Dr. Erica Barnell 33:08
Absolutely and I view, you know when, when we're talking about cancer, it's, it's really like you're describing there's a DNA change. We want to target that DNA change. So, you know, when you're thinking about diagnostics for for cancer, you identify what mutations are associated with the cancer, and then you employ a targeted therapy that can address that mutation. With IBD, it's a little bit different. We're thinking about pathways or mechanisms of pathogenesis. So for example, a patient with IBD could have dysregulated T cells, which means that a specific immune cell in their body is going crazy and accidentally attacking their GI tract. So what we do at Geneoscopy is is we measure the amount of T cells that are present in the GI tract, and we compare it to a healthy individual, or we compare it to your T cell burden five months ago, when you felt great. And if it's dysregulated, or there's too many T cells, or those T cells are really activated, then we can recommend to you that you take a therapy that would hopefully start to regulate that level of dysregulation and maybe make the inflammation go away. That's kind of our approach for addressing, predicting therapeutic response.
Doc Mok 34:29
And then, you know, using these different signatures, are you able to determine anything regarding like different phenotypes, like some types of IBD, like ulcerative colitis may spot respond this way, versus Crohn's may respond this way.
Dr. Erica Barnell 34:44
Yeah, and again, it's, it's, it's very, you know, similar to kind of where we were in cancer a while ago. You know, I think medicine is a series of grouping and splitting. We want to group things together. We want to split things and. And right now we're in a splitting stage for for IBD. So, you know, within Crohn's, within, you know, you see, there's a number of different monsters there, right? You know, not every Crohn's disease is the same. Sometimes it's the mucosal barrier, sometimes it's T cells, sometimes it's neutrophils, sometimes it's, you know, microbiome related. Sometimes it's you had an infection, and your immune system is going crazy trying to fight that infection, and it accidentally attacked your GI tract. So that's our hope is to be able to generate within Crohn's disease or within ulcerative colitis subtypes that we can identify as the mechanism of why there's this inflammation and why you are experiencing those symptoms, and then leverage the litany of therapies that are being developed to indicate which one might be efficacious for that specific dysregulation in your body, or recommend like you're describing, you know, maybe it's what you're eating, or maybe it's what you're putting in your body, or maybe it's too much exercise or too little exercise. You know, there's so many things that that cause inflammation and that cause this response, and we hope to be able to study that and make recommendations for our patients.
Doc Mok 36:24
Yeah, it's interesting, because they're such young patients, right? There's a control aspect. And I've had patients that are like, I do not want to be on medication. I do not do not want surgery. Like, what? What else can you offer me? Obviously, these are not severe cases that are emergencies, but, you know, you try to meet patients where they're where they are in their life, and I've had patients go into remission by just changing diet or lifestyle things. So I think there's, like you mentioned, there's just so much that we just don't understand about this condition, and maybe determining those differences in how they're getting their symptoms may allow us to target those lifestyle interventions too. There's a lot of power there.
Dr. Erica Barnell 37:07
And I think you talked about, you know, this patient population is exposed to so much trauma at such a young age that even if I can provide them with reassurance, you know, on a semi annual basis, where they provide a stool sample to a collection kit that comes to their house that they don't really have to go to the doctor, and they just do it and we say, yep, you look great. Your GI tract looks great. You know, even just mitigating that anxiety around having a flare, or expecting a flare, mitigating the anxiety around having to go to the doctor's office and being, you know, exposed to, you know, whatever trauma is there, or re exposed to the trauma that's there. I think being able to provide that to a patient in itself, is is pretty meaningful, which is great.
Doc Mok 38:02
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