Thermo Fisher Scientific
Allergic and autoimmune diseases are regarded as key global health challenges.1,2 The prevalence of allergic diseases is rapidly increasing across the world, and estimates suggest that as many as one in ten people may suffer from one or more allergic diseases, ranging from mild rhinitis to severe anaphylaxis or asthma.1 Autoimmune diseases are estimated to affect as many as one in ten individuals, with more than 100 different disease types identified to date.3,4
As a leader in in-vitro diagnostics, our ambition at Thermo Fisher Scientific is to enable millions of people around the world to receive the right diagnosis for their allergic or autoimmune diseases. Here we discuss some of the challenges in this field and how we are working to overcome them.
Addressing the diagnostic complexities
Both allergic and autoimmune diseases can be challenging to diagnose. The sheer multitude of triggers of allergic diseases, and the fact that some patients may be sensitised to multiple allergens or allergen components of the same allergen, can complicate the diagnostic process.5,6,7,8 Similarly, autoimmune diseases often express similar symptoms in different conditions.9
The heterogeneity and complex nature of these diseases mean that, even with a thorough patient history, diagnosis based on this alone can be difficult.10,11 In vitro diagnostic solutions can provide high sensitivity and specificity.11 Technologies and platforms, such as immunoassays, molecular diagnostics and mass spectrometry, can detect and measure the levels of specific antibodies, antigens, or other biomarkers in blood or other biological samples.12 These help to aid clinicians in the accuracy of their diagnoses and guide a patient’s optimal management and treatment strategy.
At Thermo Fisher we deliver products and solutions that enable our customers to push the boundaries of innovation for the diagnosis, treatment and follow up of allergic and autoimmune diseases. Our portfolio includes tests for a wide range of allergens and autoimmune biomarkers, which can help provide a comprehensive and personalised profile of each patient's condition.
Our ImmunoCAP™ allergy portfolio is based on over five decades of research and development. We offer the broadest range of allergen specific IgE blood testing options worldwide,13 all designed to be fast, automated, easy to perform, interpret and report. While many people are familiar with skin prick testing for allergies, specific IgE blood tests offer many benefits over traditional methods.13 This approach increases the likelihood of making a diagnosis with greater specificity, while reducing risks to the patient due to possible cross-reactivity or clinical symptoms that do not match the sensitisation obtained in the laboratory.13
Within our portfolio are ImmunoCAP Specific IgE tests, considered the gold standard in in-vitro allergy diagnostics,14 with close to 500 whole allergens and allergen mixes and over 100 allergen component tests,8,13 which can be performed irrespective of a patient’s age, skin condition, antihistamine use, or pregnancy.15,16 Taking a serological measurement of allergen-specific IgE antibodies, using our ImmunoCAP Specific IgE tests, can provide the clinician with a measure of a patient’s allergic sensitisation profile.7 Tests display results with good precision, reproducibility and report down to 0.1 kUA/L limit of quantitation (detecting extremely low levels of IgE), based on proven assay technology.7,8,17,18
Our EliA™ autoimmunity solutions include a portfolio of more than 50 clinically relevant, high-quality tests to aid in the accurate diagnosis of autoimmune diseases, such as coeliac disease, rheumatoid arthritis, anti-phospholipid syndrome, connective tissue diseases, and more. With an optimised balance of specificity and sensitivity, EliA tests help healthcare providers gain additional insight used to support disease-specific diagnoses and optimise patient management.
Thermo Fisher Scientific
Bringing innovation closer to patients
Across Thermo Fisher, we are working diligently to make our diagnostic solutions and services more accessible in primary care.
Our ImmunoCAP Specific IgE tests are a convenient diagnostic blood test for all. In general, primary care providers can order the test directly, rather than through a specialist referral, which can help to optimise referrals and the diagnosis and treatment process.19 Additionally, ImmunoCAP™ Rapid test is a quick and user-friendly point-of-care test performed in near-patient healthcare settings, such as doctors’ offices and nurse stations.20,21,22 Research suggests it can identify as many as 95 percent of symptomatic patients sensitised to any of the included allergens.22
ImmunoCAP Tryptase assay, part of the allergy portfolio, measures transient tryptase level increases. It serves as a risk marker for severe anaphylactic reactions and, when continuously elevated, guides mastocytosis evaluation.23 Similarly, our EliA tests for autoimmune diseases can provide quick turnaround of results from a blood sample, helping physicians to rule in or out specific conditions and guide further testing or referrals.
Partnering for impact
At Thermo Fisher, we proudly partner with other innovators, including research organisations, biotechnology companies, and digital health startups to co-create and co-deliver new testing solutions that help address unmet patient needs. Using intelligent services, such as AI, machine learning and big data analytics, we are developing and validating new biomarkers algorithms, and platforms that can enhance the performance, usability, and accessibility of the latest testing solutions.
By innovating and collaborating we believe we can seize the opportunities to meet our ambition, and, ultimately, help reduce the burden of allergy and autoimmune diseases on individuals, healthcare systems and societies at large.
1 - Aldakheel FM. Allergic Diseases: A Comprehensive Review on Risk Factors, Immunological Mechanisms, Link with COVID-19, Potential Treatments, and Role of Allergen Bioinformatics. Int J Environ Res Public Health. 2021 Nov 18;18(22):12105. doi: 10.3390/ijerph182212105. PMID: 34831860; PMCID: PMC8622387.
2 - Miller FW. The increasing prevalence of autoimmunity and autoimmune diseases: an urgent call to action for improved understanding, diagnosis, treatment, and prevention. Curr Opin Immunol. 2023 Feb;80:102266. doi: 10.1016/j.coi.2022.102266. Epub 2022 Nov 26. PMID: 36446151; PMCID: PMC9918670.
3 - University of Oxford. Autoimmune disorders found to affect around one in ten people. Available at: https://www.ox.ac.uk/news/2023-05-06-autoimmune-disorders-found-affect-around-one-ten-people Last accessed July 2024
4 - Autoimmune Association. Available at: https://autoimmune.org/resource-center/about-autoimmunity/ Last accessed July 24
5 - Allergy Insider. Multiple Allergies and the Symptom Threshold. Available at: https://www.thermofisher.com/allergy/us/en/living-with-allergies/symptom-management/symptom-threshold.html Last accessed July 2024
6 - Alessandri et al. Clin Transl Allergy (2017) 7:21 DOI 10.1186/s13601-017-0158-7
7 - EACCI. Molecular Allergology User Guide 2.0. Available at: https://eaaci-cdn-vod02-prod.azureedge.net/KnowledgeHub/education/books/MAUG_2_20221214_EBOOK.pdf Last accessed July 2024
8 - Thermo Fisher Scientific, Direction for Use. ImmunoCAP Specific IgE
9 - The Myositis Association. Overlapping Autoimmune Diseases. Available at: https://www.myositis.org/about-myositis/complications/overlapping-autoimmune-diseases/ Last accessed July 2024
10 - Smith HE, et al. J Allergy Clin Immunol 2009;123:646–650. https://pubmed.ncbi.nlm.nih.gov/19135237/
11 - Maecker, H. T. et al. Nat. Rev. Rheumatol. 8, 317–328 (2012); corrected online 1 October 2012; doi:10.1038/nrrheum.2012.66
12 - An introduction to diagnostic testing in laboratories. Available at: https://www.thermofisher.com/uk/en/home/clinical/clinical-genomics/molecular-diagnostics/diagnostic-testing-laboratories-intro.html#ivd Last accessed July 2024
13 - Casas, M., Esteban, Á., González-Muñoz, M., Labrador-Horrillo, M., Pascal, M. and Teniente-Serra, A. (2020) VALIDA project: Validation of allergy in vitro diagnostics assays (Tools and recommendations for the assessment of in vitro tests in the diagnosis of allergy). Advances in Laboratory Medicine / Avances en Medicina de Laboratorio, Vol. 1 (Issue 4), pp. 20200051. https://doi.org/10.1515/almed-2020-0051
14 - Crameri, R., The crux with a reliable in vitro and in vivo diagnosis of allergy. Allergy, 68: 693-694. https://doi.org/10.1111/all.12177, 2014.
15 - Gupta D. Allergy Testing - An Overview. Indian Pediatr. 2019 Nov 15;56(11):951-957. PMID: 31729325. Available from: https://www.indianpediatrics.net/nov2019/951.pdf
16 - Pali-Schöll, Isabella et al. “Allergic diseases and asthma in pregnancy, a secondary publication.” The World Allergy Organization journal vol. 10,1 10. 2 Mar. 2017, doi:10.1186/s40413-017-0141-8 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333384/
17 - Van Hage M, Hamsten C, Valenta R. ImmunoCAP assays: Pros and cons in allergology. J Allergy Clin Immunol. 2017 Oct;140(4):974-977. doi: 10.1016/j.jaci.2017.05.008. Epub 2017 May 25. PMID: 28552762.
18 - Duran-Tauleria E, Vignati G, Guedan MJ, et al. The utility of specific immunoglobulin E measurements in primary care. Allergy. 2004;59 (Suppl78):35-41.
19 - Laboratory Medicine 2023;54:473-478; https://doi.org/10.1093/labmed/lmac147
20 - ImmunoCAP™ Rapid Asthma/Rhinitis Adult Directions for Use 52-5257-EN/14
21 - ImmunoCAP™ Rapid Wheeze/Rhinitis Child Directions for Use 52-5253-EN/17
22 - Hedlin, G., et al., Allergy Diagnosis in Children and Adults: Performance of a New Point-of-Care Device, ImmunoCAP Rapid. World Allergy Organ J, 2009. 2(7): p. 138-43.
23 - ImmunoCAP™ Tryptase Fluoroenzymeimmunoassay Directions for Use 52-5467-EN/06
