CEO Talks: A Global Perspective On Molecular Allergy Diagnostics

MADx focuses on molecular allergy diagnostics and is already represented in more than 60 countries with the ALEX. But what is the global perspective on allergy diagnostics?

Christian Harwanegg (CH): Manufacturers of allergy diagnostics divide the world into different classes: first world, second world, third world. In the first world - for example, the core countries of Europe, the USA and Japan - allergy diagnostics are already widespread.

In the second world, in the so-called emerging countries, the structures are much more dynamic due to rising living conditions, better nutrition, and more health awareness. An example is East Germany after the fall of the Berlin Wall, where there was a big increase in allergies due to the newly achieved prosperity.

When we talk about third world countries, you have to remember that people's immune systems are constantly bombarded with germs, parasitic diseases, malaria, and HIV. Allergies do exist there, but they are not a big issue because people's immune systems are busy with other problems.

In a way, allergy is a "first world plus" and hygiene problem. In this context, it will also be interesting to see what will happen after the COVID-19 pandemic - after years of wearing masks and constantly disinfecting our hands, and children having little contact with other children, relatives, or dirt.

How are allergies currently diagnosed, are there different preferences on different continents?

CH: There are different schools of thought. In Europe, molecular diagnostics is the most advanced. Austria is and was also strongly represented in research here. The Medical University of Vienna was a leading centre in the invention and establishment of molecular allergy diagnostics in the 1980s.

In many parts of the world, in vivo provocation (e.g., administration of food, pricking the skin, etc.) is still very dominant. According to first-world prevalence data, we can assume that 30% of people are sensitised, but only a fraction of them are actually tested for allergies. Many allergy sufferers are never tested during their lifetime. When testing is done, it is usually in-vivo. Skin tests, patch tests and provocation tests are widely used, with the skin test being the most popular. It is simple and quick to perform and carries little risk for the patient. The provocation test with food is different - because in the worst case, the patient can suffer a severe anaphylactic reaction. The disadvantage of the skin test is that the prerequisites must be right: it should be done with a perfect reagent, the patient should not have any skin problems and should not be taking any medication.

The skin test also often serves as a pre-test, the result of which is confirmed by in-vitro testing. In the in vitro test, economic reality is a big filtering factor. The patient is either tested for only a few allergens or must pay himself if an extensive panel is to be covered.

The status quo: What are the weak points of allergy diagnostics globally, and how can they be improved?

CH: Tests that are performed live on the patient - such as skin tests - have the problem that the quality of the reagents used is indefinable. Allergens are often missing because they could not be extracted, or they are often contaminated. Cross-reactivities often arise that cannot be resolved. So standardisation is one of the main problems. A good example is the prick-to-prick test, where first a food is pricked, and then the patient's skin. Everyone knows that not all pineapples are the same, not all apples are the same. In vivo tests are strongly influenced by factors such as medication and skin diseases like neurodermatitis, and this makes the results difficult to read and interpret.

In contrast, in vitro testing is largely independent of patient-specific influences. Taking medication such as cortisone or antihistamines has no influence on the in vitro test.

What would be the economic benefit if precise in-vitro allergy diagnostics such as MADx tests were to be promoted more?

CH: There are various studies on this that have been carried out by interest groups of the EU Parliament. For example, there is a study that states that 142 billion € could be saved annually if patients were diagnosed correctly from the beginning and subsequently treated correctly. Of course, we have to look at this critically, as these figures are based on model calculations that try to derive an economic damage retrospectively.

Essentially, there are two problems: People are not tested enough, and those who are tested often get an incomplete or wrong result. In the worst case, people are not treated at all or are even treated incorrectly. This causes direct damage to the health of the patient, but also great indirect damage to society through loss of work, reduced quality of life, and premature death.

Immunological diseases are divided into stages, and often there is a change of stage which is known as “progression” in medical terms. What starts as hay fever can develop into asthma. If you intervene in time, you can stop the jump to the next stage. But once you have reached that stage, there is no turning back, there is no medication or therapy.

It has been clear for over 40 years that molecular allergy diagnostics could solve many of these problems. There is greater standardisation, cheaper manufacture, and better clinical predictive power. The problem is that a large number of parameters are tested. What is usually tested with 3 or 4 parameters must be broken down molecularly here. At the moment, these parameters are still sold at a high price, and this is not affordable for health systems. Our goal as MADx is to make this technology, which has so far only been positioned for the absolute top segment, mainstream. Molecular allergy diagnostics should be cheaper, affordable for everyone and understandable for every doctor.

Why is it so much easier for companies like MADx to gain a foothold in Eastern European countries? On the other hand, what are the barriers in Western Europe and in Austria?

CH: In countries where the patient is self-paying, we clearly see that the decision is based on the best price-performance ratio. If an allergy test with 10 allergens costs almost as much as a test with 300 allergens, and the blood collection is even less invasive for the more extensive test, even a patient who is financially weak will, in case of doubt, opt for the test that offers them added value.

In more western countries like Austria, we are confronted with the health insurance problem. From an economic point of view, it is a loss for the doctor to attend to a complex allergy patient, because they have to attend to 10 patients per hour in order to make a profit. There is a lot of catching up to do in the health system. A rethink is needed here: if we focus more on diagnostic and therapeutic prevention in the future, it would save a lot of money in the medium term - but it will cost the system more in the short term.

A look into the future: Where will molecular allergy diagnostics go in the future? To what degree will precision medicine and patient-tailored allergy diagnostics become established? What will it take for that to happen?

CH: To establish precision medicine, we lack data above all. Prevalence studies may break the data down to allergen sources, but there is no data on combination with therapies - for example, which therapeutic approaches are suitable for which patients with specific molecular patterns. As MADx, we are trying to generate this data with our digital ecosystem, but we can't do it alone - this is where the whole industry has to work together.

In the future, we will probably completely move away from extract-based diagnostics, which are difficult to standardise, to molecular diagnostics. In molecular diagnostics, we will perhaps go one step further and in future break down to epitopes, i.e., individual sub-areas of the protein, in order to predict precisely whether a patient is susceptible to severe reactions or not.

As MADx, we want to make precisely these tools suitable for mass use by medical professionals. We want to help doctors from other specialties to interpret findings correctly. Not every dermatologist is an allergy specialist, but of course they care for allergy patients. We must support these doctors with knowledge and efficiency, they should get a condensed and precise treatment suggestion from us. We don't want to replace the doctor, but we want to make his life as easy as possible.

In addition, through our consumer concepts, we want to try to pull the patient into the test cycle through low threshold offers. There will also be a lot of movement in the direction of telehealth in the near future - how much and how quickly depends on the geographical and social conditions. In emerging countries, it will be much quicker to implement because there are fewer strong lobbies that can block this development.

In the future, there will probably be standardised questionnaires that a patient can go through online. An algorithm will then decide which tests make sense for the patient, for example for allergies or other diseases. This way, no critical infrastructure is blocked, and after the first classification, another algorithm or a specialist can decide how to proceed with the patient. This is in everyone's interest, including the patient's - if only because of the time saved.

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