Allergy and autoimmune diseases

Iona Everson at PMGroup spoke to Martin Danielson, VP Global Marketing, ImmunoDiagnostics at Thermo Fisher Scientific about allergy and autoimmune diseases and the importance of accurate scientific testing

Iona Everson (IE): What is driving the growing demand for advanced immunoassays in allergy and autoimmune diseases, and how do Thermo Fisher Scientific’s product portfolios address this need?

Martin Danielson (MD): We have two different product portfolios in our diagnostic area, covering allergy and autoimmunity. They are different diseases but they have some things in common, including the continuous rise in the prevalence and incidence of both autoimmune and allergy-related diseases. There are many different reasons for that, but there are also some commonalities in that they are quite difficult diseases to diagnose. For example, a delayed diagnosis of a food allegy can lead to inappropriate food avoidance diets and unnecessary referrals to physicians. As a result, it can take quite some time for both allergy and autoimmune sufferers to get a diagnosis. The tests we offer can help patients to either get a more detailed diagnosis or get a diagnosis more quickly. As a company, we work to educate healthcare professionals (HCPs), labs and patients about the role of testing.

IE: What advantages do Thermo Fisher Scientific’s diagnostic tools, such as the ImmunoCAP and EliA testing portfolios, offer over traditional diagnostic methods for both patients and clinicians?

MD: There are different ways of testing, based on patient symptoms. For example, with skin prick testing, allergens are applied to the skin to see how each patient reacts to each different allergen. There are also different types of in vitro diagnostic testing available, that are done by testing blood samples. ImmunoCAP, our allergy portfolio, specifically provides quantitative test results that help to assess which allergens are causing the antibody or immune reaction, as well as the level of sensitisation. We have a long-standing product portfolio in this space and the consistency, level of quantification and quality of the tests that we provide offer an accurate indication of that immune response. On the autoimmune side, it’s slightly different – HCPs look at a combination of different tests to ensure patients get the correct diagnosis. Similarly, we control the tests from start to finish – from the very beginning of raw material production until the very end, when a result is produced and provided to the patient. The clinical quality, sensitivity and specificity of our tests helps them stand out and aid in diagnosis by providing additional context to the clinical picture that is assessed by HCPs.

IE: How does having a broad and integrated European footprint in R&D and manufacturing strengthen Thermo Fisher Scientific’s expertise in diagnostics?

MD: We have a strong European heritage, including a Centre of Excellence in Sweden, where we have R&D and manufacturing capabilities. We also have a Centre of Excellence in Freiburg, Germany, where the autoimmunity test portfolio was developed. In both instances, we have benefited from working closely with academia. If we look at allergy and at IgE antibodies, they were discovered around 50 years ago as part of a close collaboration with academia and, together, we developed the knowledge around the antibodies and associated testing. So, being close to academia and to the patients helped in developing the diagnostic tests. The tests are for common diseases – allergies affect almost two billon people globally and close to 10% of the population today suffer from some sort of autoimmune disease. Being situated in Europe, and being part of such a large population, gives us an advantage, along with our access to clinical research and medical facilities, and our footprint in Europe is something we have built up over the last 50 years, especially in the allergy and autoimmune sectors.

IE: What role could expanded biomarker research and emerging technologies, including AI integration, play in advancing allergy and autoimmunity diagnostics?

MD: We currently have about 600 different tests for allergies and about 50 different autoimmunity tests for around 100 different disease states – the way we will continue to evolve will be not necessarily aiming for all the different segments of the market but rather focusing on segments where there are clinical gaps that we can cover. For example, through molecular diagnostics, we can break allergies down from the whole allergen, which is a complete substance, to different specific proteins that patients can be sensitised to.  Component resolved diagnostics can distinguish between genuine sensitisation and cross-reactivity, improving treatment precision. We’re currently looking at new markers that can help us answer new or unanswered questions, which in turn can help to generate better diagnoses. This is true for both allergy and autoimmunity, as we are trying to identify how we can complement an already quite comprehensive test portfolio by adding new markers and new tests that are designed to close any remaining gaps and provide better patient diagnostics.

When looking at new technologies, such as AI, there is a lot of potential to integrate this into our assay portfolios, as well as into different types of internal and development processes. Such technologies are not fully integrated into products yet, and there is a longer lead time before their implementation, given the design and control processes around product design – but as a company, we recognise the potential and we’re investing in it. We have yet to see how it will help us design better products in the future and how well it can be integrated, but there’s ample opportunity to look at larger data sets and available information and identify how it can be applied in a different way.

From a development perspective, AI can help us process data in a different way and draw conclusions from larger data sets. From an instrument and software perspective, we can start utilising AI to better operationalise how we help our customers. We can provide earlier indications that they need support or better understand the complexity of certain requests. Once such technologies are integrated and implemented, we can provide better services – provided there’s full control, traceability and design control from a regulatory perspective. Benefits would also be gained in day-to-day operations, which is a different type of innovation but one that’s very important for our customers, to enable them to run their labs as effectively as possible and provide improved resource usage and staff optimisation.

IE: How can increased automation in diagnostic workflows, such as with Phadia instruments, benefit both clinicians and patients?

MD: Traditionally, we have taken manual processes and moved them over to systems that are fully automated, to improve time efficiencies. This frees up time for other lab work that may require more human involvement and more complex interaction. It also allows for a faster turnaround – automation can shorten the processing time from when samples come into the lab to the point where the results can be sent back to HCPs and patients.

Improving productivity is embedded into automation, enabling staff to spend less time on some tasks and more time on others, for example, training, to help counter the shortage of knowledgeable staff. Quality improvements can also be achieved through automation by increasing reproducibility and decreasing error rates. Its benefits range from making sure that hands-on time is reduced and time is freed up for other things in the lab, to providing more reliable and accurate results to HCPs more quickly. There are many different opportunities, and AI will play an important role in continuing to ensure improvements moving forward.

IE: How will Thermo Fisher Scientific’s current R&D investments and initiatives shape the next five years of allergy and autoimmunity diagnostics?

MD: Our plan is to continue to fill the gaps where we see there is a clinical need. It’s important that we prioritise and deliver the right markers – the ones that have a clear clinical value that will help HCPs make more informed decisions, while ensuring that the necessary tests are available. Integrating this into our products is also important, such as through providing additional information about our testing or identifying different types of test algorithms that we can implement as new tests are developed. It’s about listening to the clinical questions and using them to identify new markers that can help to close those gaps and answer those questions.

Over the last few years, and especially across the in vitro diagnostics industry, there is a common theme of the increased burden of upfront proof that is required. As a result, it’s important to ensure that we bring the right products to market, especially with the increased burden of innovation across the industry. Our main focus area is to ensure that we produce high-quality results that can help to close clinical gaps.

IE: What are the main challenges in patient education regarding allergy and autoimmunity testing, and how might these be addressed?

MD: One common issue is making sure that the patients actually get tested. We have many symptomatic patients that aren’t necessarily getting tested – in some parts of the world, for example, up to 40% of the population has some sort of allergy, but we see a much lower degree of testing being done.

The challenge is making sure that symptomatic patients can get tested or get access to a test, with accessibility and awareness of testing being a further challenge because there are many different disease areas where HCPs require more education. Driving education surrounding allergy testing and its opportunities is therefore vital.

For autoimmunity, it differs slightly. There are a number of different specialists or primary care HCPs that can be consulted, but sometimes the symptoms are more diverse, so it takes time to identify them. That’s why we’re actively working to provide better educational tools, along with more information relating to these disease areas. Our aim is to help ensure that HCPs, patients and our lab tech customers are equipped with the right materials and available resources. For example, we have a website that provides information that is accessible to patients. For HCPs, we provide an allergen encyclopaedia that provides them with information specific to different allergens, how those allergens may impact patients and what a good treatment modality for those patients may be. We also work with our lab tech customers to provide further education and we work with a vast network of opinion leaders and clinical researchers across the globe. Together, we help drive education and ensure that patients can access additional information alongside their HCPs. Knowledge is key, but it’s difficult for HCPs to keep track of all the different disease areas, so we’re working to ensure that HCPs – including primary care physicians and allergy specialists – have the right information at the right time.

IE: Given that overlapping symptoms can complicate diagnoses, how can improved collaboration between HCPs, specialists and diagnostic partners streamline the patient journey?

MD: While there are different types of interactions, there also needs to be an understanding of the roles different HCPs play, and the type of questions that may arise in different areas.  In some instances, we have worked with primary care networks and helped identify what could be a suitable first line of testing, what could help HCPs when patients show up with specific symptoms, what could be a suitable test or which patients should be referred to specialists, as well as which patients could benefit from a different type of treatment or could have different indications that should be followed up. We also work with specialists who focus on autoimmune and other diseases, as well as with primary care physicians and networks, to see how we can provide the right information or advice using specific knowledge. This helps ensure that patients are offered suitable testing, and that the right patients get the right tests at the right time. Given the increasing burden on healthcare, it’s important to ensure that the correct tests are being done and that HCPs use the resources they have as effectively as possible. We aim to work with different stakeholders to share some of our in-depth knowledge with them, both on autoimmune and allergy diseases, and the benefits that our tests provide.

IE: How is Thermo Fisher Scientific working with HCPs to enhance awareness of appropriate testing protocols and the interpretation of results?

MD: We do a lot of different activities in this regard, many of which are in close collaboration with HCPs, given our expertise and the history we have in the field. We work with both HCPs and labs, and we have different types of tools for each, including educational resources. We also actively work on digital platforms, co-hosting webinars and podcasts with labs, key opinion and scientific leaders, and clinical experts. We are also engaging with different types of scientific communities and societies to provide additional information and resources. This diversity helps drive different types of education, and we appreciate the close collaboration that we have with experts because those relationships really bring additional value. For example, where we may have expertise on our testing and how that can be performed, HCPs can put that into a clinical perspective or relate it to the guidelines of the respective area or country they’re working in. It’s through different ways of interacting with our customers and clinicians in the field and seeing how that continues to drive education that we can raise awareness.

IE: With the increasing availability of alternative testing kits online, how can patients be guided to access the right diagnostic tests at the right time?

MD: When looking at both allergy and autoimmunity, part of the challenge patients currently have is getting the correct diagnosis. Both disease types are fairly complex to assess, as autoimmune diseases can have overlapping symptoms and patients can have sensitivity to several allergen proteins that cause slightly different reactions. Our tests aid in diagnosis, but it’s vital to get a clinical history from each patient and an assessment from their HCP, and that’s where we see the benefit of having more traditional in vitro diagnostic tests, compared to tests that might be available to us as consumers. If we conduct that testing ourselves, we won’t necessarily have the same ability and knowledge that HCPs would apply, and this has been a guiding principle for us. Where we bring additional value to HCPs is that we can provide some answers that they might not get from a clinical history or from a discussion with the patient. Even after skin prick testing, not all the dimensions of a disease can be identified – our tests can provide complementary information that helps make that clinical decision. Consumer tests often lack that additional valuable information that helps guide the diagnosis correctly. While it may be beneficial for consumers to have something that provides a digital answer, given the complexity of autoimmunity and allergy testing, patients will likely benefit more from getting their assessment from their HCPs.

IE: What role do partnerships with HCPs, laboratories and healthcare organisations play in promoting equitable access to allergy and autoimmunity diagnostics?

MD: It differs depending on location but we have a close collaboration with our clinical labs and HCPs, and that’s how we can help to ensure that when symptomatic patients seek help – and not all of them do – they are able to consult with educated HCPs. We want to ensure that we can contribute as much as possible to educating HCPs, including sharing more information about allergies and allergy testing. If we can provide more information about autoimmune diseases and the testing that is available, that’s the best way we can improve equitable access to testing. Through driving education and awareness, we can also ensure that we promote the right tests for the right patients at the right time. Having the appropriate testing is also important, as is ensuring that our testing is in line with clinical guidelines. These guidelines differ between countries and regions but ensuring that we align with the current advice and recommendations is key. Depending on the speciality, the primary care physician may need one set of information, whereas an allergy specialist will be looking at different types of information, so we also want to ensure that the right information gets to the right HCPs or to the right lab, so they can also provide patients with the best care through testing.

IE: How do you anticipate clinician and public education evolving over the next five years to improve access to diagnostics and patient outcomes?

MD: It’s very important to focus on evidence and data-driven decisions in line with testing guidelines, as well as new learnings and benefits that come from testing. As we continue with our testing and add new products that close some of the clinical gaps, we also need to help educate the public and HCPs on developments to ensure that new advancements are being brought to HCPs and patients. The best way for us to do that is something that we have done historically – that is, to work closely with our partners and customers to understand their needs.

It also involves medical and clinical collaborations with research institutions to ensure that we understand their needs and how we can help them share that knowledge within their fields. We can also listen to the clinical questions they may have, and work to provide the answers to both patients and HCPs.

We will strive to adopt technological advancements like webcasts and improve the way we provide information and education, including through utilising AI and similar tools. One of the challenges we currently have is striving to provide medical information in as many different languages as possible. This can be quite complex, because we need to ensure that quality is maintained. The time, effort and investment needed to provide information in different languages and through different channels can be quite demanding. New tools will open up new opportunities to provide more education in different ways that can be both cost-effective and adapted to consumers’ needs, whether that’s patients, HCPs or lab techs.

Iona Everson is Group Managing Editor at PMGroup