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We explore the rising prevalence of allergies in the U.S., with nearly 1 in 3 adults and over 1 in 4 children affected. Gary Falcetano, a health care executive, explores how primary care providers are stepping up to fill the gap left by a shortage of allergists. We discuss the limitations of traditional allergy testing and the benefits of introducing allergen component testing to improve diagnosis, management, and patient care.

Gary Falcetano is a health care executive.

They discuss the KevinMD article, “Why you need allergen component tests to support your allergy diagnosis.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today we welcome Gary Falcetano. He’s a health care executive. Today’s KevinMD article is “Why you need allergen component tests to support your allergy diagnosis.” Gary, welcome to the show.

Gary Falcetano: Thank you so much, Kevin. It’s a pleasure being here.

Kevin Pho: All right, so you are a health care executive, and before we get into your article, just briefly share your story and journey.

Gary Falcetano: Sure. So I’m a PA by training. I’ve been clinically practicing for over 25 years. I’m currently the U.S. scientific affairs manager for allergy at Thermo Fisher Scientific. So in my division, the ImmunoDiagnostics division, we make Phadia laboratory systems, the ImmunoCAP specific IgE blood testing. And as part of my role, I work with researchers around the country, around the world, that utilize our technology to advance the science, but I also do educational programs such as we’re doing today.

Kevin Pho: All right, perfect. So let’s go straight into your article, allergen component tests and why we should use those to support your allergy diagnosis. So tell us the events that led you and your co-author Niti Chokshi to write this article, and then we could talk about the article itself.

Gary Falcetano: Yeah, so I educate primary care clinicians, allergists, allergy fellows every day. That’s an integral part of my job. And there’s still major gaps, especially when it comes to primary care around allergy care. We know that initial training programs in allergy, whether it’s med school, NP school, PA school, definitely with limited time there’s just limited information available. So most of what we get is in postgraduate training.

Kevin Pho: So tell us about the article itself, and maybe tell us about how we can fill out some of those gaps in knowledge.

Gary Falcetano: Yeah, absolutely. So I think before we talk about the article and allergen components, it’s important to level set, right, that when we’re talking about the potentially allergy mediated diseases, it’s important number one to phenotype, right? Are they allergic or not? First of all, there’s a lot of overlapping symptoms between those allergic, non-allergic phenotypes, and that really requires a detailed, really well done structured history, and then combining that with a diagnostic test.

So typically with allergy we need to do whole allergen tests first, right? We want to see if there’s a sensitization there that really can be correlated with symptoms. Once we figure out there is a sensitization, then figuring out is that sensitization true clinical allergy can be a little bit more challenging, because we know that we can have sensitization without clinical symptoms, which is not clinical allergy.

Kevin Pho: All right, so tell us typical presentations that I would see as a primary care physician in the exam room that would get me thinking about your technology and allergy testing.

Gary Falcetano: Yeah, so I think there’s two major disease states. On the respiratory side, I think that’s where primary care, I mean that’s bread and butter, right, Kevin? So we’re talking about rhinitis, we’re talking about the various upper and lower presentations of respiratory symptoms. Anytime we see a patient like that, we need to consider what role allergy is playing.

We know 60 percent of adults, 90 percent of children have allergic triggers that really play into and drive their symptoms, right, patients with asthma. On the rhinitis side, we also know that there’s a lot of patients that are not allergic but have allergic-like symptoms. So these are the patients you’re seeing every day, I think, in primary care, where assessment of allergic sensitizations can really play a role.

Kevin Pho: So somebody in my exam room with these allergic rhinitis type symptoms, could be seasonal allergies, maybe something more, typically we wouldn’t send them straight for allergy testing. So tell me the profile of a patient that we would think about sending to an allergist for allergy testing.

Gary Falcetano: Sure. So I think the main reason we wrote this article is that allergy testing is not just for allergists, right? We know primary care providers all across the country are utilizing this testing every day. And it’s really because I think for too long we’ve done really empiric therapy. We based our treatment on what’s suspected based upon history, and we know that often that history is wrong when it comes to either guessing whether this is allergic or not, and then specifically guessing what’s driving the symptoms.

Why it’s important in primary care is to get at the root cause. So if something looks allergic and we’re pretty sure it’s allergic, we can throw all kinds of therapeutics at it. We have nonsedating antihistamines, inhaled nasal steroids, inhaled antihistamines. But the point is, sometimes we need to find out number one, is it allergic, but even if it is allergic, what are all the sensitizations that are adding up to cause those symptoms?

So we know that there’s something called an allergic threshold, or allergy symptom threshold. When we exceed that, we get symptoms, but we don’t know what are the different causes. So whether they be things like pollution, things like cold air, things like viral illnesses, and then allergic triggers. Kevin, do you know most patients that are allergic are allergic to more than one thing?

So if it’s tree pollen season and someone comes in with allergic symptoms, we say, OK, you have a tree pollen allergy, do this. But what we don’t realize is it may be the dust mites, it may be the pets, it may be something else that’s also combining with that tree pollen to make their symptoms so difficult to control.

Understanding what they’re allergic to, getting at the root cause of it, and we don’t put people in a bubble, but doing bedroom only interventions to reduce the exposure to those things they’re truly allergic to, can have a dramatic impact on symptoms, can make medications more efficacious, and really provide a better experience for the patient, that we’re not just guessing, right? We’re actually being more personalized in our care.

Kevin Pho: So tell us the spectrum of diagnostic options we have to work this up.

Gary Falcetano: Yeah, so I mean we started the conversation around allergen components, so I think we need to go back there. When we’re talking about respiratory first, the whole allergens are great from a sensitivity standpoint. So if you get a negative and you’ve tested for all the suspected triggers, or the most common suspected triggers, OK, now they’re not allergic. But once they are allergic, again figuring out what in that sensitization profile is real and not. Now for the most part it’s going to be real, but we can take a deeper insight with allergen components.

So specifically, now in common availability in the U.S. is actually pet allergen components. So these are individual proteins within the dog and cat allergen that can actually present with either different symptoms, can help us be more precise when we’re figuring out potentially what pets will cause symptoms, and will also allow us to know what a patient’s risk profile is. So do we need to take this pet allergy more seriously, because they could potentially develop a more serious phenotype of disease? Potentially, if they’re a child, could they develop additional respiratory diseases? So they may be presenting with mild rhinitis, could they have asthma at age 16?

And there’s been studies that show knowing their sensitization profile, these individual components can really help us better manage their disease, and also, as you mentioned, better figure out who best needs a referral to allergy for potential of allergy immunotherapy, or if we’re talking about asthma, potentially use of biologics in someone with uncontrolled disease.

Kevin Pho: So tell me what the test is like itself. Say a patient comes in and I’m interested in ordering these component tests. What exactly would that look like for the patient?

Gary Falcetano: Yeah, so what we have, the major laboratories offer what are known as respiratory allergen profiles, and these are the most common allergens, both indoor and outdoor allergens, that are responsible for the majority of symptoms. So we don’t want to test for every grass, tree, or weed that grows in your area, right? They’re geographic profiles, but they’re also designed for cross reactivity. So 20, 25 different allergens can give us a really good negative, positive predictive value.

When it comes to pets, these respiratory profiles can be selected to reflex to the individual pet component. So if a dog is positive, the cat is positive, it reflexes to the individual protein, so you’re not testing those proteins if they don’t have a positivity to the extract.

Kevin Pho: And in terms of what’s standard of care when we send people to an allergist, what do they typically do in contrast to what you’re talking about?

Gary Falcetano: Yeah, so allergists use specific IgE blood testing kind of interchangeably with skin prick testing, and I think that’s what we all think of when we think of sending a patient to an allergist, right? So typically allergists use skin testing with whole allergens, and they also use specific IgE blood testing, kind of depending on the patient, the situation. Sometimes they use them together, kind of in a complementary manner.

What the skin testing can’t tell us is those individual proteins. So that’s where allergists really rely on the component testing to have a more in-depth picture of exactly what’s going on. And there’s a couple of really cool things when it comes to these individual proteins. So I’d love to talk about the potential to tolerate a female dog.

So there’s certain proteins that are only found in male dogs. They’re actually called prostatic kallikreins. They’re only produced in the male dog’s prostate. So if you’re monosensitized, or only sensitized to those proteins, it’s known as Can f 5, or prostatic kallikrein, you can potentially tolerate a female dog. That’s insights that we never had with traditional testing.

Kevin Pho: And these component tests, are they skin tests or are they blood tests?

Gary Falcetano: No, they’re all blood tests.

Kevin Pho: So they’re done at a molecular level.

Gary Falcetano: Yeah, exactly.

Kevin Pho: So give us a scenario, a typical case study where a patient could undergo component testing and it made an appreciable difference in their treatment course. Is there like a case study or hypothetical patient that you can share with us?

Gary Falcetano: Sure, no, absolutely. So one I speak to, we found it’s a 5-year-old little girl. This is a very common case both in primary care and allergy, right, where a patient presents with her mom suspecting cat allergy, because they have a cat. She has fairly regular rhinitis symptoms from the cat, they’re pretty sure it’s the cat, but her older sister wants a dog. We hear this all the time. Should we get a dog? What should we do around this, right?

So this patient would be tested typically for her whole allergens. In this patient’s case it came back positive for both dog and cat. Now without allergen components, and with an unclear history around dogs, we’re probably going to make the recommendation, really probably should not get a dog. And then what should we do with the cat?

So currently there’s some therapeutics for cats actually. There’s a cat food now that’s been developed that is an anti-Fel d 1 cat food. Fel d 1 is the molecular component in cats that causes a majority of the symptoms. If you’re sensitized based upon testing to Fel d 1, it would be a perfect idea to get this cat food. It actually reduces the expression of Fel d 1 in the cat saliva, subsequently reducing patient symptoms.

This patient though, again, we saw the whole allergens, both were positive. Looking at her component profile, she actually had none of the significant species specific proteins for dog. So in this case we may say, you know what, you may be able to tolerate dogs. We’ve confirmed your cat allergy based upon your whole extract plus your components, and we’re not quite sure about the dog, we need to trial the dog.

That same exact patient, if she’d come back with positive species specific components for the dog as well, then we’re making a totally different recommendation. We’re saying no, you probably do need to avoid both of those species.

And then finally, if we look at the number of components she’s sensitized to, it gives us a risk profile. So we say, you know what, maybe she’s sensitized to four or five of these components, this is a patient that maybe we even need to think about rehoming the cat. We definitely need to think about a referral to allergy, potentially allergy immunotherapy for the cat, right? Because this is someone who potentially could develop asthma by the time she hits adolescence, based on some of the studies we’ve seen.

Kevin Pho: And today, how common is allergy component testing typically ordered? Is this standard of practice, or is it something that could be improved on in terms of the number of clinicians who order this?

Gary Falcetano: Yeah, so we haven’t talked about food testing, and I don’t know that we really do have a lot of time to talk about food, but in the same way that the pet components have let us be more precise in our diagnosis, food components do the same thing. So they can tease out an irrelevant positivity to one that is really significant and the patient is at high risk for a true food allergy.

Food component testing is actually in regular practice throughout the United States. It’s been around since probably 2004, 2005. We have milk, egg, peanuts, tree nuts, sesame, wheat. That’s in regular use by allergists, and more and more primary care pediatricians, etc. are using that as well.

The pet components is actually relatively new. It’s only being offered by one major lab, a lot of kind of smaller labs around the country, so that’s picking up traction. What I will say is though, in Europe, molecular allergy, they’ve kind of been ahead of us in this area, so there’s a lot more component-resolved diagnosis, or molecular allergy testing, going on there.

Kevin Pho: And in general, when it comes to coverage by insurance companies, are most allergy component tests covered?

Gary Falcetano: Yeah, so in general the coverage is very good. We always say, and I’m sure you’ve had plenty of these health care finance, economy discussions, people with high deductible health plans, every plan looks a little bit different. So always confirming number one, is it covered, and also number two, what your responsibility is based upon your individual plan is important. But they’re generally, yes, very well covered, especially by commercial and public payers as well.

Kevin Pho: So your goal is to get more primary care doctors thinking about allergy component tests, or just testing for allergies. So in your ideal scenario, tell us the role of component testing in your ideal world in the primary care setting.

Gary Falcetano: Sure. So certainly when we’re talking about respiratory allergens, little bit newer, but in an ideal world, anytime that we have a positive dog or cat, we suspect those allergies, we have a positive whole extract, we really need to look and take a deeper dive, because it provides us with so much more information to provide actionable steps to patients, rather than just kind of broad suggestions or recommendations that are not really based in objective data.

On the food side, we know ideally all food allergies should be managed by allergy specialists, right, that are very well versed in food allergy. We know there’s a shortage of allergists out there. There’s about 4,000, 5,000 clinically practicing allergists. There’s about 32 million people with food allergy. So primary care really needs to practice to the full extent of their scope and really understand how they can help identify and help diagnose these patients, get the ones that need to be in allergy to those allergists in the most efficient manner as possible. So in an ideal world, the components can really help us better know what we’re dealing with and inform appropriate referrals.

Kevin Pho: And what do we have to look forward to when it comes to allergy testing in the foreseeable future?

Gary Falcetano: Yeah, so I think we continue to see the research around additional allergen components. I mentioned that whole allergens are very good from a sensitivity standpoint, they rule out allergy very well. The more allergen components that we get, they typically allow increased specificity, so it really improves the diagnosis and it really allows us to personalize care.

So as we go into the future, I think even on the respiratory side, outside of pets, we’re going to see, we already see the utilization in Europe of pollen components, of dust mite components, mold components. All of these can help us really improve our diagnosis.

Kevin Pho: We’re talking to Gary Falcetano. He’s a health care executive. Today’s KevinMD article is “Why you need allergen component tests to support your allergy diagnosis.” Gary, we’ll end with some of your take-home messages that you want to leave with the KevinMD audience.

Gary Falcetano: Yeah, I think the biggest take-home message, Kevin, is that we need to really move away from what some of us learned in initial training, right, that we can make an allergy diagnosis based upon history alone. We know that we’re often wrong there. And our allergist colleagues, we can take a page from them, right? They have the time to do it too. They do a really extensive structured history, and then they test, and they correlate the two to make the diagnosis. We should be doing the same in primary care. Every patient deserves the best possible knowledge, even if they can’t access our specialist colleagues.

Kevin Pho: Gary, thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Gary Falcetano: Thank you.