Food Sensitivity Testing 101: Supporting Clients with Inflammation and Gut Issues

On Wednesday, October 8th, FMCA hosted a special Ask the Expert webinar with James White, founder and CEO of KBMO Diagnostics, the company behind the patented Food Inflammation Test (FIT Test). In this exclusive conversation with FMCA faculty member Monique Class, James explored how food sensitivity testing can support personalized coaching approaches to reduce inflammation and promote better gut health.

Unlike traditional food sensitivity tests, the FIT Test measures both immune reactivity and inflammation markers, providing deeper insight into how certain foods may contribute to chronic symptoms. James explained how this testing can help clients make more informed dietary choices, uncover hidden drivers of inflammation, and feel supported with tools like personalized meal plans and a patient app.

Whether you work with clients on digestive concerns, autoimmune conditions, or overall lifestyle change, this session offered science-backed knowledge and practical tools that coaches can apply through the coaching relationship.

In this interactive session, James White and Monique Class explored:

• The difference between food sensitivity exposure and inflammation, and why it matters
• How the FIT Test measures IGG1–4 and C3d, plus key gut health markers like zonulin and candida
• The role of gut permeability and immune reactivity in driving chronic health conditions
• How health coaches can support clients using personalized nutrition and lifestyle strategies

Watch the Replay

Food Sensitivity Testing 101: Supporting Clients with Inflammation and Gut Issues, With James White, CEO of KBMO Diagnostics

Transcript

Natalie: Welcome to today’s webinar. My name is Natalie. I’m here with Monique and James. We’d love if you would first put in the chat where you’re from. Kansas.

Monique: All right. Chicago. Yeah, there we go.

James: Texas.

Monique: We’re going to see UK?

James: We got a Manchester, UK. There we go. I’m not sure I can. I’m a fan of one of the Manchester teams. So I don’t want to upset the lady on the phone in case it’s the wrong one. We have London there.

Monique: There you go.

Natalie: All right. So today we’re super excited to be joined by a true innovator in the diagnostic space. We have James White. He is the CEO and owner of KBMO Diagnostics, the company behind the food inflammation test, or FIT test. It measure both immune reactivity and inflammation markers. And today, James is going to help us understand how health coaches can use the test to inform more personalized approaches to nutrition. So, welcome, James. We’re very excited to have you with us today.

James: Well, that you for this opportunity. It’s a great honor to be to kind of speak to the Academy and everyone else who’s joining as well.

Natalie: Yes.

Monique: We’re so happy to have you. James, this is such a hot misunderstood topic. So it’s going to be really great for the coaches to understand not only what the testing means, but what’s their scope of practice with the testing, and how can they really help clients navigate the results after clinicians order it.

James: Exactly. Exactly. Good, good. Well, if it’s okay, guys, let me start kind of cranking through the presentation. Monique is going to lead the Q&A afterwards. So feel free to kind of put questions in there. We’re excited to kind of go through as many as we can. So as I say, the presentation is about 20 minutes. So, hopefully, not death by slide. We’ll get through it nice and quickly for you. And then as I say, we’re really interested to kind of go through any questions that you may have.

You guys all know what FMCA stands for, but I’m going to give you what KBMO stands for. So KBMO stands for K, Katherine, my wife, B, Ben, my oldest son, M, Max, my middle son, and we kept the best to last, Olivia, my daughter. So we all have bosses or coaches. So they’re my four coaches. And we’ve been going now for about 15 years. And we’ll go through the company and some of the background on it as well.

So what we’re going to hopefully go through today, if I can move this slide on, is a little bit about the company, and then a lot more about food sensitivity testing. And I think, as Monique mentioned, go through some of the, I guess, myth busting of some of the issues there, and how we can help the coaches really help in terms of partner with the practitioners to kind of help really understand those test results, and really guide the patients in terms of…support them in terms of kind of as they go through the whole process. So we’ll talk about the Food Inflammation Test, which is our main product, as well as the Gut Barrier Panel, which is now included on all the testing, which I will walk you through in the next 20 minutes or so.

Again, I couldn’t help but…you know, there’s so much great information that the Functional Medicine Academy puts out. And I thought this was great in terms of I know that we’ve got mainly kind of the alumni and existing students, but also the general public here. So I thought it would be helpful for them to understand, “So what does a health coach do?” And I think this slide here really helps kind of explain that in, I think, a really good way in terms of you’ve got the practitioners as the detectives, but you’ve really got these change activators, the people who really make things happen in terms of the coaching, in terms of going through. And I think sometimes trying to demystify what the biochemical detectives might be saying. And I think that’s certainly a really critical role.

And what I would say is we’ve got over 15,000 providers using our testing now. The ones that we see best clinical outcomes have coaches on board with them to make sure that they can really explain these results properly to patients. And I think that’s where the real magic happens in terms of, for me, the opportunity of talking with such an esteemed group of people who, in my mind, are really the change makers and make things happen within the industry as well.

So a little bit about KBMO. We were set up back in 2004. Founded around a gentleman called Dr. Brent Dorval, who’s not insignificant claim to fame was that he invented the first rapid HIV diagnostic. And so why I tell you that is everything we do is really through that infectious disease lens. And so we really are passionate about making sure the results and everything we put out are really highly accurate, highly reproducible, and are frankly easy for the patient to understand. And so everything that we do is really based around a patent that we had granted back in 2012, which again, without making any of you wade through the 40 pages of a patent, in essence, what it does is it gives us a way of measuring the whole immune system versus just half of it. And as we go through this presentation, one of the key takeaways is that we’re trying to identify which foods cause inflammation versus exposure. And we’ll kind of go into that in a little bit more detail as we go through. As I said, the technology is this multiple pathway approach.

And the nice thing about KBMO is we really own the entire value chain. So what I mean by that is all the foods that we source are local and organic. So we know exactly where everything’s come from. I can even tell you who caught the mackerel, which is on our FIT 176 test. So we are passionate about making sure we understand everything there is to know about food sensitivities, and then be able to put that in a format which we can impart to you, the coaches, but as well as the patient, given that one of our great providers that uses, Dr. Sachin Patel, talks about the patient of the future being the doctor. And so that’s what we want to do is make sure it’s easy for the patient and coaches and providers to work in tandem to kind of understand what’s going on. And we’ll talk about some of the tools that we’ve created for that.

Again, the testing is available all around the world. One of the nice things, it’s a finger stick. So again, very easy for a patient to administer at home or the practitioner or the coach to get done in the office. So again, that’s one of the nice things about this testing. It makes it very accessible for patients and the providers to run that. And as I say, everything we do is based around a lab that we have here in Boston, Massachusetts, which is ISO and FDA approved. So again, everything comes into the lab, and we’ll talk about the turnaround time, generally 7 to 10 business days. And again, we have a team of people here who, again, we’re slightly old fashioned, you’ll find out that we do things in lamination, which I think is helpful for people to see. But everyone was probably talking about AI, but we talked about lamination to try and make it easy for the patient and the provider to understand what’s going on. We don’t even have a phone system because what we want is when the coaches or the providers call into our office, we want you to be able to speak to a human. We want to make sure that we can remove any friction there is in terms of understanding or making sure that the testing results are really helpful for the patients that you all do such a good job of working with.

So we’ll talk first about the food sensitivity test, so the FIT test. Again, just to kind of set out the store a little bit. You hear about these terms and they’re frankly intermingled by, I would argue, coaches, providers, patients, and everyone across the board. And so you’ve got allergies, intolerances, and sensitivities. An allergy and a sensitivity, they’re both immunological responses. The allergy is instant, think very severe reactions. A food sensitivity, the key difference there is the fact that what you’ll see is it is a delayed reaction. So it’s delayed up to 72 hours from when the food can be consumed. So it doesn’t always get delayed that long, but it can be. And so again, in many respects, that’s why the testing makes much more sense for this because again, if you have an allergy, it’s cause and effect. You eat something and you have that instant reaction, but that delay of 72 hours is really tough for the patients to work out, “Okay, what did I consume in a 72-hour time period that may well be leading to the symptoms that I’m presenting with when I come in and see the provider/coach?”

And again, when you talk about when and what are the types of symptoms that we see, as I mentioned, we’ve got just over 15,000 providers and coaches running the testing now. I’m often asking, what’s a good patient to run this test on? And so as you’ll see on this slide, there’s a range of different things that come up. And the root cause of all of them is really inflammation. And so what we’re trying to work out is can we provide a test which enables you to have a really good understanding of which foods are causing an inflammatory response, which again is the root cause of all these different disease states.

And so what we’re trying to work out is can we provide a test which enables you to have a really good understanding of which foods are causing an inflammatory response, which again is the root cause of all these different disease states. And so what we’re trying to work out is can we provide a test which enables you to have a really good understanding of which foods are causing an inflammatory response, which again is the root cause of all these different disease states. And so what we’re trying to work out is can we provide a test which enables you to have a really good understanding of which foods are causing an inflammatory response, which again is the root cause of all these different disease states. Again, the nice thing about it, we’re covering all three levels of the immune system. Because we’re not just looking at exposure, we’re going on to look at inflammation, and by looking at the innate immune system, that gives us a great coverage of all these areas.

So again, the key barriers and so skin. We’ve seen some amazing reactions in terms of…based around skin and improvements around that, because again, when a patient has psoriasis, or any kind of rosea, or anything like that, it’s generally an inflammatory response. So that’s why I think we’ve seen some great results around these barriers. The innate immune system, and we’ll talk a little bit more about the complement activation as we go through. And then the adaptive, which is more of the IgG, the exposure element as well.

So again, I know this is a gentleman that Monique knows well, but Dr. Joel Evans who used to be…when when we first got going as a business, we were very fortunate as having him as our head of clinical affairs. Dr. Joel Evans would say the immune complexes and inflammation associated with foods is an underlying problem for all of the conditions he sees on a daily basis. So again, if you go back to that slide, if you think about it, this is a great test to run on any of the patients or any of your clients who have got some level of inflammation underlying, which can frankly be low level, but then it can trigger some level of symptom if it’s consumed in a higher level. So again, that’s the great thing with this test. We’re looking to individualize test results to give patients some really helpful tools and information about how they can go about their daily lives.

So again, as I mentioned, one of the key takeaways here is we’re looking at which foods cause you inflammation versus exposure. There are some wonderful companies out there measuring IgG on its own. The limitation of that is not those companies. It’s that pathway, because in essence, what you’re trying to avoid is telling your patient or your client which foods they’re exposed to. Because again, we all have to be exposed to foods. And I know under the coaching auspices, you look at nutrition as one of the key elements anyway. So again, we have to make sure patients are exposed to foods. That’s not optional.

The limitation with that IgG is it basically tells you all of the foods they’re exposed to. So that in essence is when we talk about the high rate of false positives. And so that’s really what we’re calling them because again, you have to eat food, that’s not optional. But again, we don’t want to call every food out because, again, when you start doing that, you start hearing about these terrible situations where patients think they’re in some kind of food prison. And so that’s not the case. If you just look at IgG, it is because generally you’ll end up with a lot of what we’re talking here, the false positives.

So the nice thing about the testing that we do is it’s a finger stick, as I mentioned upfront. So again, all we’re looking to do is get the patient to put the…use the lancet and fill out the five blood spots. That then gets sent into the lab. Again, I think the key part about the kit is obviously the requisition form, and everyone loves the band-aid as well. So again, very simple, very easy to do. In the office, ideally, or again, it could be sent directly to the patient and we’re well set up to do either pathway. And again, as I mentioned, it’s stable for 30 days, which is a beautiful thing in terms of we’ve got clients and coaches using this test as far away as New Zealand, Australia. We have a very strong presence in the UK. I saw Manchester come up. I saw London come up. We’ve got a great team under the leadership of Charlotte Hunter over there. And they’re shipping constantly back from the UK to our lab in Massachusetts.

So as I mentioned before, the tests that are measuring the IgG are really…by this pictogram here are on the left-hand side. So as I say, they do an excellent job of telling you what they’re exposed to. The limitation is that gives you all these false positives. So a great example of that is I ran… Back in the day, there was a company called Everlywell, I think they’re still around. They were an IgG only company. And so I ran their test. And then on the right-hand side here, you’ll see the patented approach that KBMO has, which is looking at these multiple pathways, which I’ll go into a little bit more detail. But on the left-hand side, we have the IgG-only test. So I ran the IgG, and then I ran our test on the same day.

When I got the test results back on the IgG, I had 25 foods positive, which again is back to that food prison and the nightmare scenario where a lot of providers will tell me, “James, I spent the first five minutes walking the patient back in off the ledge because they were so worried that there was nothing they could eat. Whereas when I ran the KBMO test on the same day, I came up with five.” So again, it’s really helpful from a compliant standpoint from the patient, but also a believability. There’s no way someone can be sensitive to 25 foods. Five makes a lot more sense. And so we got there through the brilliant science of Dr. Brent Dorble, who I touched on at the very beginning.

So again, this multiple pathway enables us to…yes, it’s important to know what they’re exposed to, the patient. But more importantly, we do the secondary screen to say, “Okay, of the foods you’re exposed to, which ones are causing inflammation?” As we all know, the root cause of all disease state. So again, what we’re trying to do is identify which foods cause inflammation, not exposure, and then it has all those multiple benefits of compliance, eliminating the kind of whole food prison type scenario as well.

So we offer four basic tests today. So we started off with the numbers you’ll see here, the 22, the 132, and the 176. A link to the number of foods colorings and additives that we measure, and I’ll show that list on the next slide. One of the, I think, real breakthroughs that we’ve had over the last four or five years is we’ve also added a Gut Barrier Panel. We’ll talk a little bit more about that in detail. But what we really want to do is try and avoid the coaches and providers guessing to see, “Well, I think the patient has leaky gut or not.” So we’ve come up with a panel that really helps address that. So you can look at what might be going on from an inflammation standpoint linked to their nutrition, which is clearly an important element that the coaches look at. As well as now looking at immune health with a Gut Barrier Panel to say, “Oh, my gosh, if something’s elevated in that area of the world, maybe that’s why we’re seeing so many food sensitivity.”

So again, we’re trying to give the coaches and the providers a way of rather than guessing that, which historically is what they had to do… And again, no fault of their own. There wasn’t a panel out there. The idea was to combine all those things together to give you a really good snapshot of what might be going on from a patient’s nutrition and dietary perspective.

So as I mentioned, we have these three panels, all of them come with that Gut Barrier Panel, because again, we don’t want you guys have to guess that. We want to make sure that that piece of information is included. And again, that’s always been our approach, to include as many of these things as we can. So we have the FIT 22, which is the foods here in yellow. The FIT 132 is the yellow plus the green here. And then the FIT 176 is everything on this panel. Again, this is not the AI, but the laminated sheet that we love to get out to providers and coaches. So you can show that to your patients and help guide them in terms of the panel that may work best for them in terms of as they make their choices.

The report comes back. As I mentioned, it’s a finger stick. It gets run. It gets sent into our lab. And generally, 7 to 10 business days later, we will send you the results back. And the results are intentionally straightforward and color coded, because as I said, we want you the coach and the patient and the provider to be able to quickly identify which of the foods the patient needs to eliminate from their diet. And so what you can see here is we’re expecting the foods which are in the red, orange or yellow are the ones that the patient needs to eliminate. And again, what we generally give the advice is that they need to take them out for a semester. So about three months. When they look to reintroduce it, start with the yellow foods, then the orange, then the red. So the ones which are the kind of, I guess, the highest offenders, as it were, you want to leave those to last. So you’ve given them as much chance to kind of heal as you possibly can.

So that’s generally the approach of how long do you eliminate for? Is that three months or semester? And then in terms of the reintroduction, be exposed to one or two servings of the food, and then look 72 hours later, because as we said, 72 hours is the time that those foods could have ingested and have an issue in the body. And so then look to see whether the symptoms return or not. And so, again, I often say sometimes this is a great test for amnesia, because it’s amazing how many patients forget how bad they were feeling when they first got the test, and then have some of those symptoms have improved. So it’s always important to try and track what are the symptoms when the patients first came in to see you. So when you look to retest or reintroduce these foods, you can really get a good balance of what might have been going on in terms of the symptoms that they presented with.

But again, the idea is that three pages is really easy for the patient and you the busy provider. Again, no coach or provider’s gonna love James or KBMO if we say, “Here’s a 25-page report on food sensitivities,” because again, I appreciate you’re all busy. Some of you may get to all 25 pages. The patient will, you may not. So the idea is, let’s make sure… We’ve got a lot of information here, but we can put it in a succinct and easy-to-interpret way for the patient and the provider.

So, again, as I mentioned, it’s a chicken and egg. Which came first? Is it the food sensitivity or leaky gut? And back in the day, when we had Dr. Joel and Monique running the test, you know, probably 10 or 15 years ago when they started working with us. You know, as I said, I’d be up in New Hampshire. And again, as all of you know, as we all run small businesses, we wear many hats. So I was selling the test up in New Hampshire, and I hear from some providers, “I love the fact it’s patented. I love the fact you’ve eliminated these false positives. You know, and I love that all these foods are organic. So it makes it very easy for us to kind of zero in on the key foods. But I don’t run this on everyone because some of my patients, I think, have leaky gut.” And as I said, that was the genesis behind coming up with the Gut Barrier Panel.

So here you’ll see it on the screen. We look at four key markers, and we look at two pathways to try and help identify what might be going on. So we’ll talk on the next slide each of these markers in more detail, but I’ll give you a quick summary. So you’ve got an idea of how you can kind of interpret the Gut Barrier Panel. Hopefully with the foods is straightforward. Red is bad. Dark green is good. Keep moving. So we applied that with the Gut Barrier Panel as well. So red is an issue. Dark green, things are looking good. And what we’ve done in the last six months is we’ve added these golden triangles. So, again, as Beyonce said, everything to the left. So what we want to do is move everything to the left. We don’t want anything in the red, we want it all to the left.

And so what we do and what we’re seeing more and more of, the kind of cadence of testing is everyone will get tested. And then six months later, we’re encouraging people to just redo the Gut Barrier Panel, because I’m hoping in that six months, you’ve eliminated those foods. And so you’ve changed your diet. So we don’t really want to worry so much about the food as much as saying, “Okay, did we heal the gut?” Because as I say, if we all believe that all disease begins in the gut, let’s make sure we’ve monitored that. And more importantly, we’ve got the evidence to show at the end of this that actually by measuring that gut again, we can see did we have that desired effect of moving these triangles from the right to the left, which is what we’re trying to do to make sure that they’re all in negative territory.

So the four markers, as I mentioned them, we’ve got candida, zonulin, occludin, and LPS. So if you want to think about them in these terms is candida is indicative of some kind of early dysbiosis. So it’s kind of like an early warning signal. The zonulin and occludin, hopefully you can see the screen, are really…the zonulin is looking at the tight junctions, how they’re functioning. The occludin is looking at structurally, are they still together, or are they beginning to come apart? And fourthly, LPS, which is lipopolysaccharides, or as a good friend of ours, Dr. Rob Silverman, talks about El Diablo. So again, he says if that’s up, then Houston, we’ve got a serious problem. So the idea is how do we look at those four markers and then treat accordingly?

And then the other two elements we came up with as well are the IgA1 and IgA2. IgA is a secretory marker. So generally indicative, it’s early stage, still localized in the gut. If it moves across the IgG1 through 4 in the complement, generally means it’s more systemic, as well as it’s been around a longer time scale. So for this patient, for example, the IgG is fine. The zonulin may be getting a bit close to the edge, but generally what you’re seeing is nice and green. However, the IgA, there’s some early stage issues going on. First of all, some level of dysbiosis, and then also with the zonulin, some indication that there may be something going on with those tight junctions as well. So as I mentioned, the candida, what we’ve described.

The only thing I will highlight on our zonulin assays, as I mentioned, we’re the only patented food sensitivity test. And we said about looking at zonulin because again, it became a key marker on the back of the amazing work that Dr. Alessio Fasano did in the early 2000s, linking zonulin and celiac disease in particular. And he was seeing certain positivity rates, which really were compelling to make sure everyone was running a zonulin test. Unfortunately, the test that was out there was created by a German company. It was very un-Germanic in many respects because it was cross-reacting with haptoglobin and pro-perdin. It was highly unstable, so you were getting a different result from the morning to the afternoon. And so we decided that that wasn’t a great outcome.

So the great Dr. Brent Dorval and myself went down to see Alessio Fasano. He’s based here in Boston as well at Mass General, and again, at Harvard. So again, we had the opportunity to meet with him and he said, “Gentlemen, the issue we have is that zonulin is a great marker. As you’ve seen from the work I had published in the ‘Lancet.’ The problem is those issues that you’ve just highlighted. It’s cross-reacting. We’re seeing a low positivity rate. And again, the other issue we’re seeing, it’s very unstable.” So what we did is we spent a four-year time period coming up with a zonulin antibody test, which is uniquely stable, which hopefully we’ll show in one of the later slides as well, but more importantly, it addressed the issues.

And so again, the reason I highlight that is lots of people talk about, “Oh, I’m measuring a zonulin.” You always want to make sure it’s the antibody because the protein is unstable. The other element that you sometimes may come across is I’m running it in stool, not blood. And again, when I asked the direct question to Dr. Fasano, who said, “James, all my seminal research was done in blood. Hence why we believe that this should be a blood test,” which was much relief to my lab techs who now continue to do all the testing in blood versus stool.

So again, we’ve created a number of key compliance tools because we want to make it simple for the patient to kind of follow through, and understand the results as well as be able to implement what’s going on, obviously in the auspices under the direction of one of the great health coaches that are on this call as well. So as I mentioned, we’ve made the report easy to read. We’ve got different handouts that we provided. We also have a patient app. So the concept is the results go back to the coach/provider. They review them with the patient. And then 14 days after that, we send the patient the app. And on the app, they’ll see a meal plan, which again comes with all the FIT 132 and 176 results, which is individualized per patient. So again, trying to push this positive narrative that says, “Look, we want you to be successful. And here’s some suggestions of what you might want to eat.” What you’ll see with some of the other companies out there is they give you a long doom and gloom list of things you can’t eat.

So our approach is, “Look, let’s look at a small list of things you can’t eat. But more importantly, here’s some suggestions based off your results of what you can eat.” And the other concept is let’s put it on your phone. So then it’s much more easy for the patient to be compliant, because as I say, there’s one thing I can guarantee all of you who are listening today that you all have a cell phone. So the idea, let’s put it on the phone and then hopefully if they’re grocery shopping, they’ve got it. And if they’re out for dinner, they’ve got it. And it turns out for you coaches and the providers, it’s an unbelievable marketing tool, because what happens is one family member or one friend gets the test run. They’re out for dinner. They go, “Oh, my gosh, I couldn’t possibly eat the salmon. Why is that? I got my test run, my local coach or through the provider, and they told me to take the salmon out. It’s amazing. The symptoms I was presenting with have improved dramatically.” So again, it’s a really nice side bar in terms of one of the advantages of this.

The other great thing about this food sensitivity test is if they get tested for their triglycerides, as an example, the provider tells them, “Oh, my gosh, your score is 500. That’s terrible. Go see the coach. See if we can work you out.” The idea with the food sensitivity, there is no judgment attached to it. So this is a much more positive outcome for the patient. They’ve gone the extra mile to work out which foods are causing them an inflammatory response, given that that will aid their longevity and them as an individual. So they generally wear it as a badge of honor that they’ve been tested and are very comfortable to share those results with their friends and family. “Oh, my gosh, it was eggs. It was dairy,” whatever it might be. And so, again, it’s another great thing about this test. We want the patient… And again, if they’re fortunate enough to have a good coach working with them, they’ll have that more positive approach, but sometimes, not always. So the idea is this gives them that positive outlook and outcome based on the test results when they get those back.

The clinical support. Again, we’ve got provider handbooks for the coaches. We’ve got a number of people on call, particularly a lady called Dr. Val, who’s always around to answer any questions that you may have. The handbook’s really helpful. We’ve cut that down into smaller bits that we do every summer, which is the summer reading program. So, again, that’s always available. We’re always doing a number of different webinars where we have coaches and providers coming on, and talking about how they’ve implemented into their practice, and some of the positive outcomes they’ve had as well. So that’s all available on the website in terms of to make sure that we’ve got that information available for you as well.

And again, lastly, but not least, we’ve done a number of clinical studies showing how accurate the testing is, but not just run by James in James’s lab with patients chosen by James. What we’ve done is we’ve partnered with labs in Chengdu, China, New Delhi, India, and we’ve asked them to run samples. And then we’ve replicated those samples to show how reproducible the testing is. We did an IBS study as well, and we saw a dramatic reduction in the IBS severity score, which again, was tremendous evidence of how well the test works. More importantly, we also saw high sensor CRP go down, as well as homocysteine levels.

Also with our Gut Barrier Panel, we took 40 patients. We ran those here in the U.S., and then had them repeated 15 days later. And we saw a 98% agreement with those samples. So again, if you think back to the Zonulin protein assay, which is highly unstable, that just shows how robust this testing and the assays that we make really are. And we did another study with 75 patients in China, another one with 30 in Japan. And generally what we saw was about an 80% improvement, or actually 82-point-something percent over both of those studies. And those two, all they had was a three-month elimination diet. So that was the only intervention. So I think, again, my hope and thought would be if we’ve got the coaches using this and supporting patients over that three-month period or the semester, as we talked about, then those outcomes will only be improved. But again, 8 out of 10 is a great place to start from. So again, that with the aid of health coaches as well, I think will be a really good place to go. But more importantly, we have that validation independently done rather than always done in our lab.

So, again, in conclusion, it’s the only patented food sensory test on the market. We put a lot of effort into compliance tools because we want the patient and the coaches to be successful in terms of the outcomes. And we have many clients who’ve been with us for over 10 years now, because, again, they’ve seen great clinical outcomes. And that’s really the key of what we’re doing. And in that time, we’ve made a number of dramatic improvements. So we’ve added 44 foods to make the FIT 176. And all those foods are based on feedback from coaches and providers like we have on the call today, because we want to listen to you and make sure we can improve the testing. Again, we’re the first company to develop the new zonulin test and the first company to come out with Gut Barrier Panel.

So, again, what we’re trying to do is really base what we do based on world-class science. But with the addition of the amazing feedback from providers and coaches like we have today telling us what you need us to improve to make sure that we continually drive this market forward to give the growing number of patients who are looking for coaches and providers to kind of give them the tools that they need to ensure the positive clinical outcomes that we see today.

So, Monique, it looks like they’ve been busy in the chat room. We’ve got 17, and I think there’s a few kind of early doors as well. So let’s see how quickly we can go through it.

Monique: So, first of all, James, great presentation. I really appreciate it. And I want to underscore what you said in the beginning that the change activators are the coaches, and they’re the big translators. They’re the boots on the ground actually helping explicate the data, and helping people actually create plans that are doable for them. So I appreciate your tests. The thing I want to call out for everybody too that’s on this test that’s super important is food dyes and other additives, right? It’s huge because it’s not always the food. It’s what’s been put in the food, and it’s hard to tease that out. So it can be game changing for people to know it’s the red dye, right? So kind of a big ticket item. So you did a great job.

I’m going to go through the ones that were pre-submitted first. I think you probably already answered this, but we have somebody who lives in Italy, is working with a client, wants to know, number one, can you do the test in Italy? Thumbs up for yes, you can do the test in…

James: So if you contact us at the info@kbmodiagnostics, we’ll probably…we’re working with our UK office. And so they deal with Europe for us. The nice thing for you is all you need to do is send the samples back to the UK, and they’re shipping multiple times a week to the Boston office. So hopefully that’ll make it a little bit cheaper for you versus having to ship all the way back to U.S.

Monique: Excellent. The second part of the question is the client she’s working with has dermatitis. How does she know, and this is probably more of a me question than a you question, whether she should do a SIBO test or look at the gut barrier, you know, look at intestinal permeability? Like I said, maybe a me question, but go ahead.

James: Let me give you a quick James response, but then we’ll get a much more accurate Monique response about that. But what we would see on that is, again, we’ve seen some unbelievable responses because if you think of dermatitis, it’s an inflammatory response. And so if you can identify, are there some foods triggering that? Then again, this is where I think we’ve seen some really good clinical outcomes based on looking at the foods. Because often it’s their diet, which could be causing that inflammatory response versus SIBO, which I would say is a bit more located in the gut. So I would suggest that the food sensitivity would be a great starting point, because if we can identify some foods which are triggers, then what we’ve generally seen is really, really good outcomes on skin-related issues. Monique, back to you.

Monique: Yeah. So just for clarification sake. So when you have SIBO, it’s bacteria in the small intestine. You’re not going to catch it on a blood test and you’re not going to catch it in stool, and it rolls down. Right? So if there’s pathology in the small intestine, it’s going to cause, you know, dysbiosis in the large intestine. So just because you see it in the large intestine and you treat that, if things don’t get better, like James said, you want to think about SIBO. But SIBO is pretty specific, meaning people will bloat within 10 to 20 minutes after eating. That’s kind of patho-pneumonic. So if they’re not bloating and it really just is dermatitis, I would go with James’s test over SIBO first. If they’ve got bloating 10 to 20 minutes after eating, it’s going to be a SIBO test. If you do a food sensitivity test, FODMAPs aren’t going to show up because they’re not sensitive to FODMAP foods. FODMAPs feed the bacteria, which is different than them having an immunological reaction to the FODMAP foods. So they’re kind of two different things, but there’s overlap and it is confusing. But I think best thing with dermatitis, unless there’s bloating, is start with something like the FIT test. Much better thing to do first.

Can they do this test on children? Next question.

James: Absolutely. So generally, it’s from two and above. We do have some clients doing it below two. Typically, the biggest clinic I can think of doing that is a clinic looking at autistic children out in Phoenix, Arizona. So they do it below two. But generally two is the minimum just because, again, the immune system isn’t fully formed below two. So above two, then you’re getting the IgG and the complement. Below two, it’s more of the IgG than the complement. But again, that will vary around the two mark. But generally that’s what we’ve seen. Now, the clinic is a wonderful lady called Dr. Cindy Schneider. She’s been using the test probably for the longest of everyone, nearly 20 years. And so she’s found that it’s incredibly helpful for kind of identifying which foods are causing some of those irritations that autistic children see.

Monique: Yeah, it’d be so cool to have it, you know, know what people are sensitive to early, and try to work with that. This is a great question. If they’re not eating the food and you do the test, if they’re not eating the food often, is it still going to show?

James: It’s a great question. And so generally the way I always respond to this is we’re trying to basically work out from their existing diet, which foods are causing the symptoms that they present with when they come in and see one of the great coaches on this call. So the idea is let’s work out what it is that they’re currently exposed to is causing that inflammatory response. The other kind of corollary to that is some people say, “Well, I took out gluten or dairy 12 months ago. Can I see whether they’re having an impact or not?” So generally on those, we would suggest reintroducing a week or so before you do the test of a couple of small samples. So you can see above and beyond that 72-hour window to see what’s going on. The only caveat to that is you want to make sure that the patient hasn’t done an IGE test. So we’re not suggesting that we send them into the ER because they have an allergy to one of these foods. So, again, you want to make sure that if they say, “Well, I took it out on some doctor’s advice before,” that it was another food sensitivity test, not an allergy test, which I’m sure you’d all do anyway, but it’s worth just highlighting some of the issues there.

Monique: Yeah, so I’m going to restate that to people. So if it’s an IgE positive, that means it’s a real allergy. So you don’t want to re-provoke with an IgE test for something that’s a real allergy. So that’s what he’s saying. This is where coaches…it’s the practitioners, unless you’re a practitioner, which you may be a practitioner, it’s the practitioner that’s going to make this kind of a call. But we’re just kind of answering the question. So what if somebody does the FIT test, and it shows up that they have a high sensitivity to green beans and they say to you, “I don’t eat green beans. I hate green beans. Why is this showing up?”

James: So what one of the great things that we have in that provider’s guide is cross reactions. So you’ll see some cross reactivity occasionally with some things like that. So one of the all time classics is coffee. So I had a lady said, “My six month is not drinking coffee, kind of slipping down the stairs first thing in the morning and having coffee.” Coffee cross reacts with wheat. So, again, some of these times you’ll see a cross reaction is going on. As well as sometimes, look, well, if that’s elevated, you’re not eating it. Good news is don’t introduce that food because that could clearly cause that trigger in terms of whether it’s a four, three, or two in terms of the severe reaction or not.

Monique: Got it. Great. How does your test compare to the residents hair testing for food sensitivity?

James: Yes, I think, you know, there’s obviously different ways of doing this, but I think ours is a direct measurement to say is the IgG and the complement present within your patient’s blood. And again, if you think about the gut and everything that’s going on and how your food gets consumed, it’s through the bloodstream. Last time I looked, no one’s eating their food through their hair. So the idea is it gives you, I think, a more relevant way of measuring what we’re trying to do. So we’re trying to mimic the body in terms of… So I think that’s generally why it works much more effectively. And I think why we see the kind of clinical outcomes that we have over hair. So, again, I can’t say we’ve done a head to head. That’s probably a bad phrase, isn’t it? With hair. But again, the idea would be, you know, because we’re mimicking the body, I think that seems to have a much more accurate way of testing.

Monique: Thank you. So I’ve got a couple of interesting questions here. Somebody wrote, “Might you agree that there are seven foods that most patients are most sensitive to, gluten, dairy, peanuts, soy, yeast, eggs, and corn?”

James: Yes and no. I mean, yes, you should potentially look at that. But why not make sure you’ve individualized that information? So if they can kind of take those foods on, then you’re not considered the kind of bad ogre in the room and say, “Oh, my God, what can I eat?” If they’ve taken these seven out, oh, my gosh, what’s left? So the idea is, you know, it’s bread and water, oops, no bread. So the idea is how do we give the patient an individualized result, which enables them to go, “You know what? Good news is you can still have these things.” Of those seven, I would probably say in moderation, but rather than kind of coming over as the as the big bad wolf and saying, “No, here’s seven things you can’t touch.”

Monique: I love it.

James: What would be your view?

Monique: It’s the same thing. So, you know, people say all the time, “Well, no one should eat gluten. No one should eat dairy.” Not true. It’s not true. What is it for that individual? That’s the cornerstone of functional medicine is personalizing the recommendation. There’s some people that eat gluten that are completely fine, have no reaction. Others do. So it’s really what is the data for the client sitting in front of you? And then what happens when they take it out? What happens when they put it back in? You always want them to make the ultimate call, especially as coaches. We’re looking for people to become empowered to experiencing it from themselves. “What happens when I eat it? What happens when I give it up? Is it worth it?” Right? That’s the ultimate question of raising awareness. Somebody’s dog is barking.

Another person wrote that a functional doctor at a particular clinic, I’m not going to say the clinic, after she requested a food sensitivity test said that he doesn’t believe those tests because different labs often produce inconsistent results. What say you?

James: Unmute. Look, I think we highlighted the inconsistency upfront in terms of you’ve got a lot of labs out there who are measuring what I would say exposure to foods. And so, as I say, I wouldn’t be down on those labs as individual labs because I think they’re doing a very good job of measuring that exposure pathway. The limitation is that pathway, because as we talked about, everyone has to eat food. That’s not optional. The problem, to your point, I think that great question is, look, if it comes up with everything I’m eating, well, so what? How is that helping me? And so that’s with the FIT test where we’ve taken that that extra step that says, “Let’s find out what you’re exposed to. But more importantly, of what you’re consuming, what is causing a true inflammatory response? The root cause of pretty much every disease state.”

So the idea that I think is the difference is that you want to get a test that’s going on to that next level. And unfortunately, there’s not that many of those about. So, again, if you do a comparison of both of those, you’re going to get inconsistencies. I would be shocked if you didn’t. And so that’s one of those things, again, why you want to work with a good health coach who’s done that hard work to say, “Look, we’ve identified the right testing to work with and partner with that gets us the information that helps the patient, you know, take control by giving them information which is helpful and usable as they move forward in their daily lives.”

Monique: Absolutely. So, again, I’m just going to underscore what James was saying. The big difference in testing, one, is identifying foods that you’re actually eating that are causing inflammation. So inflammation is a pivot point of every single complex chronic disease. So as health coaches, unless you’re a practitioner, you’re not ordering the test or interpreting the test. You’re executing on the test and helping people navigate through the test as to what are the foods that could be adding to the etiology of their symptoms. And again, it’s a raising awareness. They’re taking the food out. It’s a great experiment. How do they feel? Does their eczema go away? Does the psorias go away? Does the brain fog go away? Like, does their PMS get better? You know, what is it for them?

And that’s the most important thing is what happens when they do it. It’s information upfront. What’s going on? How do you feel at the end? This is what I’m going to tell you, that oftentimes people report symptoms resolving that they didn’t even know they had. Right? They’re like, “Oh, my God, I didn’t even know I was tired. I didn’t even know that, you know, I was, you know, X, Y and Z,” fill in the blank. So, oftentimes, people are so used to particular symptoms that they don’t even realize they’re a problem until they don’t have them anymore. They’re like, “Oh, my God, this is amazing.” So again, that’s the big difference is we want to know what’s actually taking up inflammation.

So two other very specific questions that only you can answer. Is it ELISA-based test protein array panel? What is the technology used in the assay?

James: Perfect. So the testing is ELISA-based. And so the great thing about KBMO is we own the manufacturing facility of those ELISA tests. And as I mentioned before, all the foods are organic, and they’re all sourced, and we know where everything has come from, which I think is really important. We own the C3d cell line. So, again, all the elements within the test are under our control. So in this era of tariffs, unless Maine puts a tariff on Massachusetts, we’re in pretty good shape. So everything is controlled by us, which I think is key to making sure that we can guarantee the quality of the answer. And a good example of why that’s important is we run 1000 patients in manufacturing before the test is sent over to our clear high complexity lab where your tests will be run. So we want to make sure there’s a high level of accuracy and reproducibility. And you can only do that if you can control that value chain. And if you control it, then feel free to use it as you will. And so our view is we’re very passionate about what we do, and we want to measure as many upfront so that when it gets launched into the clinical lab, then we’re very confident in the results that we send out.

Monique: That’s awesome. Not everybody knows what ELISA means. Can you just define it for a population that doesn’t know?

James: Yes. ELISA, it’s a plastic plate with 96 wells. And so, again, it’s a really good point because a lot of food sensitivity tests are 96 food panels. And again, that 96 isn’t because they couldn’t think of an additional 4. It’s because an ELISA plate has these 96 wells. Now, the danger of a 96 food panel is that then you don’t have any standards of control. So as an example, for our FIT 176, we actually run 5 ELISA plates and we have 20 standards and controls. So if you’re measuring 96 wells in one plate, the accountants are very excited because you’re not wasting any plates. But I’m less excited because you don’t have any standards of control. So you’re either always right or you’re always wrong. So we don’t want to have to guess. We want to make sure that we’ve got as many standards and controls on those plates as humanly possible so we can ensure the accuracy of the results that we hand out to providers.

Monique: Excellent. So another technical question that only you can answer here. Which cells are tested? Lymphocytes, T-cells, B-cells?

James: So it’s looking, again, the IgG. So we’re measuring all of those things in terms of coming through. So whatever’s in the blood, we’re applying it to the antigens on the plate, and then we’re running the conjugate, which is a combination of the IgG 134 and the C3d in terms of the foods. And for the Gut Barrier Panel, we’re looking at the IgG 134 and complement, and then the IgA 12 as well. So again, we’re looking at multiple ways of seeing what’s going on from the immune health, the gut barrier, and then the inflammatory response with the foods coming through as well.

Monique: Got it. So here’s another question. I think they misunderstood what you said, but we’ll clarify it. The question is, “If you can remove the foods that are the most sensitive first, wouldn’t that make the biggest difference in the level of inflammation? Did you say you start with the low inflammatory foods first for the elimination diet?”

James: No, sorry. If I said that, I misspoke.

Monique: No, you actually didn’t. You were talking about reintroducing.

James: Yeah, I think I was talking about the reintroduction. You obviously eliminate all of them at the same time, because there’s generally 5 to 10, so that’s not generally overwhelming for the patient. But then when you do the reintroduction, the idea is starting with the lowest ones first. Because then you give, to your point, the most severe ones the longest time to heal. So that was I was trying to get at, if I misspoke on that.

Monique: No, you got it right. But I think it’s confusing, but it’s a really key point. And I just got to reiterate the point. You eliminate everything. And then the first thing reintroduced after the semester or the three months is the low-level foods first so that you have a longer time. So the person who asked the question was exactly right. We want a longer amount of time off the top inflammatory foods. Great, great question.

James: And just to add to that, the way to think about that is the IgG half life is 23 days. So again, the semester is three months. And then again, if you think with the red foods, then it’s taking probably another month to get to those. You’re giving it four half lives to have a really good opportunity of clearing it out of the system.

Monique: So, another great question here. “Can a health coach order this test or can only a licensed health practitioner do so?”

James: A health coach can order this test. So again, if people are interested in ordering the test, go to the website or info@kbmodiagnostics. Mention that you’ve listened to me on this call, and we’ll send you out a new account form. And again, the slides will be going out to everyone as part of the Academy anyway. And so, again, there’ll be some more information on there about a special offer on the test, because again, we’d love the practitioners to try the test as well.

Monique: Yeah. So again, coaches, it just has to be within scope, and we can have a big conversation about prescribing, diagnosing, and, you know, moving ahead with assessing, which unless you’re a practitioner, that’s going to be out of scope. So you want to be collaborating with a practitioner with this when you order this testing.

James: Monique, as I said earlier, where I’ve seen the best clinical outcomes is that combination.

Monique: It’s a great combo.

James: A provider and a coach. So that combination ensures the patient is well treated, well looked after, everything’s ordered correctly, and that’s the elixir of life.

Monique: That’s the sweet spot. So nothing gets missed. That’s what’s in the best interest of the client when there’s these collaborative care teams. So somebody wrote here, “I’m confused what you mean by organic foods. Earlier you mentioned mackerel too. What does this mean in terms of testing?”

James: So what we want to do is get the purest source of food. So the mackerel was actually caught in the ocean, as an example. So, again, that’s as pure as you can get. And so it wasn’t processed, anything else. So we take all those organic foods, and then we we go through a process of lyophilization, which enables them to go down onto the plate. So we do all of that in-house to ensure the accuracy and the understanding of where these foods come from. As Monique added as well, we look at colorings and additives. Obviously you can’t have an organic yellow dye. But the idea is, you know, those are other elements that we include on the panel because you’re finding them in three places. Processed foods, you’re finding them increasingly in supplementation, and thirdly, personal hygiene products back to those skincare issues in terms of you see them in washing powders, shampoos. And we often see cases where patients are like, “Oh, my gosh, you know, it was benzoic acid.” And again, nothing against elimination diets, but you’re probably unlikely to start on, “I’m going to eliminate benzoic acid from someone’s diet.” So the idea is, that’s why it’s important to look at those colorings and additives, and all those foods at an organic level, so we can make sure…because we’re measuring at the protein level. So we want to make sure that we’re getting the purest source of those foods. So hopefully that answers the question.

Monique: I think that answers the question. Multiple questions about what’s the price point of the test?

James: So again, that’s something we’ll send out to the crew afterwards in terms of the pricing, just to make sure. There’s three different levels in terms of… Wholesale pricing for the Academy. So we’ll do that in terms of as we send out the presentation as well.

Monique: Great. So we have a really good question that me and you can do this in tandem. We’ve heard, which is true, this is what we say at IFM and this is what we taught them in the curriculum, that the gold standard is the elimination diet, eliminating all of…kind of the major food sensitivities, right? Depending if you’re doing an 8 or a 12 elimination diet. It’s a gold standard to identify sensitivities over testing. Does this testing eliminate the need for the elimination diet to identify foods and skip to the elimination of the foods in the testing?

James: I think I would say it’s probably a fair statement to make that people’s attention span is not getting longer. So given that being the case, I think most patients, by the time they’ve come in to see the practitioner and a good health coach, they’re trying to get answers. And so it feels slightly disingenuous to them. So, “Well, it’s okay. I’ve got a nine-month program for you.” Why not get them to some really good results, personalized for them by running the test? And so nothing against the elimination diet. It certainly has its place. But the idea for a lot of patients, they’re very keen to try and get this data as quickly as they can. And so I think certainly it fast tracks the ability to kind of zero in on the foods which are causing inflammation by running the test. So that, I would say, is the difference from an elimination diet is it gives you a way of personalizing fast tracking that information. Whereas, again, I’m sure you can get that with elimination diet. But as I said, I think the reality is patients, in my experience, aren’t phoning up going, “Don’t worry, James, take an extra couple of months with that test result.” They’re looking for their answers as soon as possible. So I think that’s generally where I think probably elimination diet and a good, accurate food test would kind of slightly part ways at that point. Monique?

Monique: Yeah. I’m going to dial in. It comes down to economics and conversation. Remember, you as a health coaches aren’t making the call. You’re giving them the menu. Right? So the cheapest way to do it is do the elimination diet first and see how they feel. If it hasn’t relieved their symptoms because it’s only a month, and they could only sustain it for a month, then they’re willing to spend the money and try to personalize. Some people right off the bat don’t want to waste their time on an elimination diet. They want answers fast, and only want to take out what they need to take out. So, again, it’s not our call as coaches, or really it shouldn’t be our call as clinicians. What we want to do is give them the menu, tell them the why, tell them the differences, and ask them, “What do you want to do first?”

And there’s no harm, no foul with doing the elimination diet first if they want to do that. Then if they’re not getting the results they want, you move to the testing and there’s no harm, no foul if they’re interested in knowing up front because they say to you, “It’s just not available to me. I just can’t go off of all those foods for a month. I want this dialed in a little bit better because I want results quicker.” Then the test is an option. Again, it’s about a coaching conversation, and the patient makes the call. We lay out the menu. Now you guys know the differences. And I think that’s the best way to play it, because we’re not making the decision. They are. We’re giving them the data and the why.

So let me see if we have one more question here that’s easy to answer. Let’s see. A lot of people are asking, is it available in different countries? Saudi Arabia? South Africa?

James: Yes, we’ve got it Dubai. Yes, in South Africa. That’s through the UK still. That works well. We’ve got a number of providers in South Africa running the test.

Monique: Yeah. And then we have another question along the same lines. “If the client is eating a clean diet, no processed food, is it worth doing the test?” Only if they’re symptomatic, like if they’ve got an issue and they’ve got a perfect diet, there’s something we all don’t know about… You could react to really healthy foods and not know it. You can react to salmon. So, you know, always good to know. So just because they have a clean diet…if they have a clean diet and they’re feeling great, you don’t need to do it. If they have a clean diet, they’re not feeling well, it’s a great value add.

James: I often say everyone talks about the food pyramid. Unfortunately, it’s about as useful as a pyramid, because again, we’re all different. And so that’s the reality of it is that, you know, one person’s clean diet is maybe not another person’s. So, again, that’s where I think it really comes in, especially.

Monique: A hundred percent. A hundred percent. So I’m going to kind of wrap this up and then give James last word here. So I hope you guys realize that this is a super cool test on multiple levels for people that are really looking to personalize sensitivities and understand gut barrier issues at a very high level. And the price point he’ll show you is really reasonable. Does everybody need it? No, everybody doesn’t need anything. But it is one of the tools that we as practitioners use frequently when we need to, because we get a lot of information at one time, and it’s very personalized to the client. That’s the benefits of this. Again, the job of the coach is to have the conversation and educate them, collaborate with the clinician, and co-create a care plan that they can actually follow. What’s their non-negotiables?

Now they have the data. Can they do it? And if they can’t do it at this moment in time, but they know the data, maybe next month’s a better month because they have birthday parties and travel. So you let them determine the when, the how, what they can do based on a conversation. You educate them, help them co-create it, and you collaborate with the team. And then the key thing that James said is the reassessment and the re-provoke. Whether you’re doing the elimination diet or whether you’re doing this, the re-provoke is where they really find out what their body does with that food after a timeout. So, James, you’ve been amazing. Thank you so much. There’s way more questions, but we’ll try to answer them on the back end and have you help us. Any last words before we…

James: I think what we’re seeing now with the providers and coaches that we talk and have the opportunity to work with is, again, by adding that Gut Barrier Panel, you know, people are interested in what’s going on from a gut perspective. Generally, they’re less interested in doing stool samples. So this gives you a really good snapshot, again, back to working with the client in an easy way to try and work out what’s going on from a gut health standpoint. It’s something that’s in the news. Everyone’s talking about it. So this is a great way of giving them that information to basically lead on to, again, further questions. But it’s another great data point to say, “Look, if we retest for that gut barrier, then we can see did we heal the gut?” And I think that’s really a key element of trying to make…and as I say, when I send the prices you’ll see that second test we’re making highly affordable because we want you as coaches to have that data. You’re the guys and girls taking them through this whole thing. And so, again, if you can point to some real hard evidence at the end, that’s where I think really the magic happens by adding this testing in to whatever kind of practices and programs you have in place with your clients.

Monique: Thank you, James. All right, everybody. Thanks for your attention. We’ll get back to you on some of these questions. And also, I’m going to put out a statement about the candida. Just because the candida is positive doesn’t mean they have systemic candida. So we’ll clarify that so you don’t get confused and jump to any conclusions if you ever see it. But, James, this was amazing. Thank you so much.

James: Thank you.

Monique: Thank you all for joining us.

James: Absolutely. Wonderful. Thank you again, everyone. Much appreciate it. Thanks, Monique. Great to see you again.

Monique: Bye, James. Good to see you.