From extract-based to molecular allergy diagnostics

CEO talks #5 with Dr. Christian Harwanegg

What are the advantages of molecular allergy diagnostics over traditional extract-based methods, and why are doctors or laboratories still reluctant to use them?

Christian Harwanegg (CH): In my view, there are three main reasons: lack of expertise, low market share, and lack of reimbursement.

Firstly, many physicians do not have the required expertise and therefore do not "dare" to use it. Molecular allergy diagnostics is much more knowledge-intensive because it is based on components. The doctor must therefore already know which components are available and understand when it makes sense to use which ones.

The second reason is related to the logistics of referral. Many laboratories do not even offer molecular allergy diagnostics as part of the menu which doctors can choose from. This is another reason why the market share is still low – in the single-digit percentage range globally. As MADx, we are pioneers: if you multiply the number of our tests by the number of components, the cumulative share is significantly higher than the rest of the industry combined.

Another reason why many people hesitate is that molecular allergy diagnostics are not reimbursed by health insurance due to the scope of the test. With grasses, for example, you must test several components, and even more with food. Those responsible do not see the added value here – in contrast to available evidence – because they do not have the training.

Molecular allergy diagnostics contributes to better personalised medicine in allergology. How does this benefit individual patients and society?

?CH: Individual patients benefit from receiving comprehensive results that cover all parameters and achieve the highest level of resolution possible. By the highest level of resolution, we mean that the clinical literature and research work has already been done to define exactly what can be derived from the results for the benefit of the patient. This includes individualised avoidance recommendations for food allergies, more precise prediction of cross-reactions and better coordination of therapies. The aim is to better assess the risk – some forms of allergy never get significantly worse; others develop further and can cause asthma or anaphylaxis. The predictive value is crucial, and this must be communicated to the referring doctor so that they can maximise the outcome for their patients. Only when this process functions smoothly will there be a significant benefit for society.

We are dealing with a dogma as to how diagnostics should be carried out: Should we test predictively and extensively to recognise and mitigate problems early on, or should we test specifically after problems have already occurred? I believe that if you wait for a problem to occur and then look at it in detail and treat it, you can never derive any great benefit from it – after all, the damage has already been done.

There is huge potential for cost savings for healthcare systems if patients are correctly diagnosed and treated from the outset, but this is currently not being realised. According to model calculations by the European Parliament Interest Group on Allergy and Asthma, the potential savings in the EU amount to 142 billion euros per year. These calculations are based on existing treatment options – if better, more meaningful diagnostics were to be used, the potential would be even higher.

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How would you address concerns about the cost-effectiveness and accessibility of molecular allergy diagnostics?

CH: As far as cost-effectiveness is concerned, these concerns cannot be dispelled across the board. There are data, figures, and facts that the cost-effectiveness of allergy treatment is inefficient from a holistic perspective – i.e. from diagnosis to therapy – and represents a huge cost factor for healthcare systems worldwide. We are talking about several percent of a country's GDP.

Prospective comparative studies with significant population groups would have to be carried out to assess the cost-effectiveness holistically. One example is the mother-child health passport in Austria: A risk assessment should already be carried out in early childhood development using questionnaires, anamnesis, and family history to proactively start not only with a diagnostic concept, but also with a treatment concept. The diagnosis with the patient's test result should not be the end point; it must be followed by adequate treatment. If this fails, it is difficult to prove the effectiveness of improved diagnostics. Diagnostics must not be seen as a means to an end, but as a starting point.

How has the switch to molecular diagnostics in allergology been received by the medical community, and what steps can be taken to ensure that doctors feel well trained in these new methods?

CH: The changeover has not taken place in this sense. We still assume that the majority of allergy diagnostics are still done with extracts – in-vivo using SPT (skin prick test), and not in-vitro. The SPT is still the dominant test on the global market.

Although MADx has a high single-digit, perhaps soon double-digit share of the global market, most in-vitro diagnostics are still carried out with extracts. Molecular allergy diagnostics is therefore still a long way from becoming routine. Only ALEX can be considered as a routine, automated and affordable molecular allergy test – there is no alternative. But here again there are a few hurdles, starting with the information chain: the referring doctor must know that such a test even exists. This is not always the case, as many laboratory referral forms simply state "food panel", for example, and not the name ALEX. In addition, the test must be available and billable in the respective country.

The transfer of information from laboratory to doctor is also crucial. The goal is to offer physicians a tool that is easy to understand and work with, and from which the benefits for the patient can be clearly read. Doctors need to feel that they don't have to invest more time in selecting the right test, communicating with patients, or training to use the test.

For educational purposes, the MADx Academy , our digital training and certification platform, is certainly a pioneer when it comes to molecular allergy diagnostics. Of course, there are other online training courses and seminars, but the Academy is unique due to its scope, language availability and free access for physicians worldwide and is a great asset to provide a deeper understanding of the method.

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What trends and developments could characterise the field in the coming years?

CH: In terms of trends, the digitalisation of the entire chain – from the laboratory to the doctor to the interpretation of the results to the patient – is at the top of the list. We are thinking in the direction of a patient portal that will provide patients with even better support after receiving their test results and encourage them to make the most of their findings. The better a patient understands their results, the easier it is for them to adapt their lifestyle to achieve the best possible treatment outcome.

The second major trend that we are establishing as MADx is that we will be able to work with big data in allergology for the first time. We collect millions of patient profiles every year and the next step will be to collect clinical data. In the future, we will therefore be in a much better position to recognise global and regional patterns and define algorithms with the help of machine learning models. The aim is to derive information from this large amount of data that will clearly benefit the individual patient. It would be very useful to be able to make clear statements such as "Sensitisation to allergen X and Y in region Z leads to allergic asthma in 98% of cases”.

We can initiate this process by making the data available, but of course we can't do it alone – it must be supported by the whole scientific and medical community.