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Mastocytosis in the age of precision medicine 精准医学时代的肥大细胞增多症
Allergo Journal International Pub Date : 2025-04-03 DOI: 10.1007/s40629-025-00327-x
Frank Siebenhaar, Randolf Brehler, Deborah Christen, Karin Hartmann, Sabine Altrichter, Marcus Joest, Kristin aufm Kampe, Claudia C. V. Lang, Undine Lippert, Norbert Mülleneisen, Hagen Ott, Jens Panse, Polina Pyatilova, Peter Schmid-Grendelmeier, Petra Staubach, Stefani Röseler, Franziska Ruëff, Dagmar von Bubnoff, Nikolas von Bubnoff, Nicola Wagner, Torsten Zuberbier, Marcus Maurer, Friederike Bärhold, Ludger Klimek, Knut Brockow
{"title":"Mastocytosis in the age of precision medicine","authors":"Frank Siebenhaar,&nbsp;Randolf Brehler,&nbsp;Deborah Christen,&nbsp;Karin Hartmann,&nbsp;Sabine Altrichter,&nbsp;Marcus Joest,&nbsp;Kristin aufm Kampe,&nbsp;Claudia C. V. Lang,&nbsp;Undine Lippert,&nbsp;Norbert Mülleneisen,&nbsp;Hagen Ott,&nbsp;Jens Panse,&nbsp;Polina Pyatilova,&nbsp;Peter Schmid-Grendelmeier,&nbsp;Petra Staubach,&nbsp;Stefani Röseler,&nbsp;Franziska Ruëff,&nbsp;Dagmar von Bubnoff,&nbsp;Nikolas von Bubnoff,&nbsp;Nicola Wagner,&nbsp;Torsten Zuberbier,&nbsp;Marcus Maurer,&nbsp;Friederike Bärhold,&nbsp;Ludger Klimek,&nbsp;Knut Brockow","doi":"10.1007/s40629-025-00327-x","DOIUrl":"10.1007/s40629-025-00327-x","url":null,"abstract":"<p>Mastocytosis encompasses a spectrum of clonal mast cell disorders characterized by the proliferation and accumulation of atypical mast cells in various organs, including the skin, bone marrow, and gastrointestinal tract. Initially described in 1869 as a cutaneous manifestation, the systemic variant (SM), involving additional organs, was documented in 1949. Clinical distinctions are made between indolent SM (ISM), where mediator-related symptoms predominate, and more aggressive forms, in which organ dysfunction is the primary concern. In recent decades, there has been continuous progress in elucidating the pathogenesis, classification, and management of mastocytosis, aided by specialized networks such as the European Competence Network Mastocytosis (ECNM) and the German Competence Network on Mastocytosis (Kompetenznetzwerk Mastozytose e. V.). A significant therapeutic advancement has been the development of targeted tyrosine kinase inhibitors, including midostaurin and avapritinib, which have been utilized for several years in treating aggressive SM. Recently, avapritinib in lower dosage was also approved for ISM patients with moderate to severe symptoms. For patients with milder forms of ISM, a symptom-oriented basic therapy is recommended. The diagnosis of SM requires interdisciplinary collaboration and strict adherence to established diagnostic criteria. Moreover, innovative patient-centered approaches, such as the MASTHAVE® app, support ongoing follow-up and have the potential to enhance quality of life. Long-term research efforts are increasingly directed toward developing personalized therapies that target the molecular mechanisms underlying the disease.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 3","pages":"57 - 68"},"PeriodicalIF":0.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-025-00327-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143883597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Fundamentals of laboratory diagnostics in allergology 变态反应学实验室诊断基础
Allergo Journal International Pub Date : 2025-02-26 DOI: 10.1007/s40629-025-00323-1
Christos Arsenis, Styliani Taka,  Chrysanthi Skevaki
{"title":"Fundamentals of laboratory diagnostics in allergology","authors":"Christos Arsenis,&nbsp;Styliani Taka,&nbsp; Chrysanthi Skevaki","doi":"10.1007/s40629-025-00323-1","DOIUrl":"10.1007/s40629-025-00323-1","url":null,"abstract":"<p>The diversity of allergic disorders and their associated underlying mechanisms render allergy diagnosis particularly challenging. There is a palette of available in vivo and in vitro tests, while result interpretation must always be made in conjunction with clinical history. The focus of the present article is on laboratory diagnostics, where several diagnostic tests have been developed targeting different parts of the allergic cascade. The results of these tests may indicate the presence of clinical allergy but also provide information on disease severity, treatment options, and therapy responsiveness. First-line testing involves allergen specific IgE (sIgE) antibody measurements, and several considerations are required when choosing the exact test. Among others, the allergens to be tested, the use of allergen extracts versus molecular components, cross-reactivity aspects, cost, and geographical sensitization patterns need to be considered. There are technical distinctions between main commercially available automated platforms, which is often reflected by differences in their test results. Diagnostically challenging cases can be supplemented by tests assessing the key effector cells, i.e., basophils, mast cells, and eosinophils, as well as by tests targeting several of the released mediators, including tryptase, lipids, and histamine. Overall, non-IgE-based laboratory tests need additional standardization and research to support their clinical utility.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 2","pages":"21 - 30"},"PeriodicalIF":0.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-025-00323-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143632444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developing novel test for allergy diagnostics: using today’s biochemical techniques 开发新的过敏诊断测试:使用今天的生化技术
Allergo Journal International Pub Date : 2025-02-14 DOI: 10.1007/s40629-025-00325-z
Eric Whitters, Kelline Rodems, Yinglei Tao, Tom de Poorter
{"title":"Developing novel test for allergy diagnostics: using today’s biochemical techniques","authors":"Eric Whitters,&nbsp;Kelline Rodems,&nbsp;Yinglei Tao,&nbsp;Tom de Poorter","doi":"10.1007/s40629-025-00325-z","DOIUrl":"10.1007/s40629-025-00325-z","url":null,"abstract":"<div><h3>Background</h3><p>The key to moving beyond “bucket chemistry” in allergy testing is to tightly control the sourcing, analysis, and performance testing of the extracts used. It is imperative that each allergen extract be scrutinized using today’s biochemical techniques as an active part of the qualification process rather than the ones developed almost 30 years ago for the technologies of the 1990s. Characterization of allergens demystifies the source material and provides results in the clinical lab that are less ambiguous and are more closely related with the clinical status of the patient.</p><h3>Methods and results</h3><p>This article delivers a technical overview that outlines the requisite steps for diagnostic companies to characterize, analyze, and qualify allergen extracts, mixtures, and components integrated into their platforms. It also evaluates diverse technologies employed in both singleplex and multiplex diagnostics, highlighting the incorporation of more precisely defined biochemical materials in their product offerings.</p><h3>Conclusion</h3><p>The primary goal of this review is to provide laboratory professionals and clinicians with a systematic approach to ensure that extracts meet stringent performance requirements crucial for dependable allergen-specific IgE testing.</p></div>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 2","pages":"40 - 45"},"PeriodicalIF":0.0,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-025-00325-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143632425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Contact dermatitis: case report of an unusual manifestation in the context of an allergy to methylisothiazolinone 接触性皮炎:对甲基异噻唑啉酮过敏的异常表现的病例报告
Allergo Journal International Pub Date : 2025-01-15 DOI: 10.1007/s40629-024-00320-w
Sanjive Rey, Flurin Brand,  Oliver Fuchs MD PhD
{"title":"Contact dermatitis: case report of an unusual manifestation in the context of an allergy to methylisothiazolinone","authors":"Sanjive Rey,&nbsp;Flurin Brand,&nbsp; Oliver Fuchs MD PhD","doi":"10.1007/s40629-024-00320-w","DOIUrl":"10.1007/s40629-024-00320-w","url":null,"abstract":"","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 3","pages":"81 - 83"},"PeriodicalIF":0.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00320-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143883687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Allergen immunotherapy based on molecular diagnostics: pediatric aspects 基于分子诊断的过敏原免疫治疗:儿科方面
Allergo Journal International Pub Date : 2025-01-15 DOI: 10.1007/s40629-024-00318-4
Paolo Maria Matricardi
{"title":"Allergen immunotherapy based on molecular diagnostics: pediatric aspects","authors":"Paolo Maria Matricardi","doi":"10.1007/s40629-024-00318-4","DOIUrl":"10.1007/s40629-024-00318-4","url":null,"abstract":"","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 2","pages":"31 - 39"},"PeriodicalIF":0.0,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143632429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pivotal role of the optimal dose in allergen immunotherapy 最佳剂量在过敏原免疫治疗中的关键作用
Allergo Journal International Pub Date : 2025-01-02 DOI: 10.1007/s40629-024-00322-8
Pascal Werminghaus, Sven Becker, Ludger Klimek, Mandy Cuevas, Martin Rosewich, Frauke Hermanns, Anke Graessel, Pieter-Jan de Kam,  Matthias F. Kramer MD
{"title":"Pivotal role of the optimal dose in allergen immunotherapy","authors":"Pascal Werminghaus,&nbsp;Sven Becker,&nbsp;Ludger Klimek,&nbsp;Mandy Cuevas,&nbsp;Martin Rosewich,&nbsp;Frauke Hermanns,&nbsp;Anke Graessel,&nbsp;Pieter-Jan de Kam,&nbsp; Matthias F. Kramer MD","doi":"10.1007/s40629-024-00322-8","DOIUrl":"10.1007/s40629-024-00322-8","url":null,"abstract":"<div><p>The transitioning of named patient products (NPPs) of therapy allergens is regulated under the German therapy allergen ordinance (TAO) since 2008. The establishment of a sound dose–response relationship constitutes a pivotal aspect in clinical development programs of drugs in general. Up to now, there are only few comprehensive studies dedicated to the determination of a dose–response relationship in allergen immunotherapy (AIT) because of various challenges. Among these aggravating factors are high placebo effects, variability of trial endpoints and especially for native allergens a narrow therapeutic window and safety profile. The phase II trials of the modified allergen tyrosine associated—monophosphoryl lipid A (MATA MPL) platform for birch and grasses established convincing and significant dose–response relationships decisive for AIT product optimization. The significant dose–response relationship for birch and grass allergoids reached an efficacy plateau and allowed the definition of critical milestones in drug development such as the median effective dose (ED50) for the MATA MPL platform combining modified allergens (allergoids) with microcrystalline tyrosine (MCT) and MPL in an adjuvant system. This marked a pivotal milestone in AIT drug development allowing the definition of the “optimal dose” (optimal risk–benefit ratio) to be taken forward to phase III trial. The MATA MPL platform is characterized by a scientifically sound dose–response relationship across allergens which underlines the pivotal role of a well-defined optimal dose as a success factor for phase III.</p></div>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 1","pages":"10 - 14"},"PeriodicalIF":0.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00322-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143107858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Position paper dupilumab and vaccination 立场文件dupilumab和疫苗接种
Allergo Journal International Pub Date : 2024-12-18 DOI: 10.1007/s40629-024-00319-3
Sebastian M. Schmidt, Tobias Ankermann, Carl-Peter Bauer, Peter Fischer, Monika Gappa, Michael Gerstlauer, Matthias V. Kopp, Susanne Lau, Christiane Lex, Bernd Mischo, Bianca Schaub, Thomas Spindler, Christian Vogelberg
{"title":"Position paper dupilumab and vaccination","authors":"Sebastian M. Schmidt,&nbsp;Tobias Ankermann,&nbsp;Carl-Peter Bauer,&nbsp;Peter Fischer,&nbsp;Monika Gappa,&nbsp;Michael Gerstlauer,&nbsp;Matthias V. Kopp,&nbsp;Susanne Lau,&nbsp;Christiane Lex,&nbsp;Bernd Mischo,&nbsp;Bianca Schaub,&nbsp;Thomas Spindler,&nbsp;Christian Vogelberg","doi":"10.1007/s40629-024-00319-3","DOIUrl":"10.1007/s40629-024-00319-3","url":null,"abstract":"<p>The extension of the approval of dupilumab for the treatment of severe atopic dermatitis in children 6 months of age and older in Germany creates a potential conflict with the administration of live attenuated vaccines. According to the product information, the administration of live attenuated vaccines is contraindicated during ongoing dupilumab therapy. This position paper, written by specialists in pediatric immunology and allergology from Germany and Switzerland, aims to support pediatricians to provide their patients with the best possible treatment with dupilumab and appropriate vaccinations based on the currently available evidence, including statements and advice for clinical situations. The practical implementation of these statements requires a differentiated approach. The position paper covers the situation in Germany, with special attention to the recommendations of the STIKO (Standing Committee on Vaccination) and the Robert Koch Institute for German-speaking countries and the legal situation here.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 1","pages":"1 - 9"},"PeriodicalIF":0.0,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00319-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143108977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recommendations for patch testing with patient’s own materials in occupational dermatology 职业皮肤病学对患者自身材料进行斑贴试验的建议
Allergo Journal International Pub Date : 2024-10-30 DOI: 10.1007/s40629-024-00315-7
Cara Bieck,  Lara Obermeyer,  Katja Dicke, Antje Alberts,  Christoph Skudlik,  Swen Malte John,  Richard Brans
{"title":"Recommendations for patch testing with patient’s own materials in occupational dermatology","authors":"Cara Bieck,&nbsp; Lara Obermeyer,&nbsp; Katja Dicke,&nbsp;Antje Alberts,&nbsp; Christoph Skudlik,&nbsp; Swen Malte John,&nbsp; Richard Brans","doi":"10.1007/s40629-024-00315-7","DOIUrl":"10.1007/s40629-024-00315-7","url":null,"abstract":"<div><p>Allergic contact dermatitis is one of the most common occupational skin diseases. Due to the limited availability of commercial patch test preparations, patch testing patient’s own material (POM) is of great importance in the diagnosis of occupational contact dermatitis. In a research project (FB 317b) funded by the German Social Accident Insurance (DGUV), a comprehensive assessment of the quality of patch testing with POM in individuals with suspected occupational skin diseases was carried out for the first time in Germany. The initial results show considerable deficiencies in the documentation and in some cases also in the performance of patch testing POMs. Therefore, recommendations for patch testing POM and in particular patch testing with workplace materials are presented.</p></div>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 3","pages":"69 - 75"},"PeriodicalIF":0.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00315-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143883591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sensitizations to pollen differ between Central European and Sub-Saharan African atopic dermatitis patients 中欧和撒哈拉以南非洲的特应性皮炎患者对花粉的敏感性不同
Allergo Journal International Pub Date : 2024-10-21 DOI: 10.1007/s40629-024-00313-9
Danielle Fehr, Muriel Rentschler, Fandresena Sendrasoa, Nick Li, Anna White, Meike Distler, Claudia Lang, Gloria Masenga, Nelson Mosha, George Semango, Clara Clemens, Tahinamandranto Rasamoelina, Abel Hermann Soankasina, Fahafahantsoa Rapelanoro Rabenja, Daudi Mavura, John Elisante Masenga, Peter Schmid-Grendelmeier, Marie-Charlotte Brüggen MD PhD
{"title":"Sensitizations to pollen differ between Central European and Sub-Saharan African atopic dermatitis patients","authors":"Danielle Fehr,&nbsp;Muriel Rentschler,&nbsp;Fandresena Sendrasoa,&nbsp;Nick Li,&nbsp;Anna White,&nbsp;Meike Distler,&nbsp;Claudia Lang,&nbsp;Gloria Masenga,&nbsp;Nelson Mosha,&nbsp;George Semango,&nbsp;Clara Clemens,&nbsp;Tahinamandranto Rasamoelina,&nbsp;Abel Hermann Soankasina,&nbsp;Fahafahantsoa Rapelanoro Rabenja,&nbsp;Daudi Mavura,&nbsp;John Elisante Masenga,&nbsp;Peter Schmid-Grendelmeier,&nbsp;Marie-Charlotte Brüggen MD PhD","doi":"10.1007/s40629-024-00313-9","DOIUrl":"10.1007/s40629-024-00313-9","url":null,"abstract":"<p>Atopic dermatitis (AD) is often associated with allergic comorbidities, such as allergic asthma or allergic rhinoconjunctivitis (ARC). Sensitizations to pollen can directly impact AD, as patients can experience exacerbation during pollen season. This study aims to gain more insights into the pollen sensitization patterns of AD patients in Central Europe compared with sub-Saharan Africa (SSA).</p><p>We performed a case–control study involving a total of 90 participants: 20 AD patients and 10 healthy controls (HC) each from Switzerland (CH), Tanzania (TZ), and Madagascar (MD). We collected clinical data and serum samples and performed a multiplex IgE test (ALEX<sup>2</sup> Allergy Explorer, MacroArray Diagnostics, Vienna, Austria).</p><p>The prevalence of ARC and asthma in AD patients was similar in all countries (ARC: 60% TZ, 70% CH, 75% MD; asthma: 25% TZ, 30% CH, 20% MD). Total IgE levels were significantly higher in both SSA HC populations compared with the Swiss HC. The analysis of specific IgE levels revealed major differences in sensitization patterns between Africa and Europe, especially regarding grass pollen allergens. Swiss AD patients were sensitized to various grass pollen such as Bahia grass, Bermuda grass, common reed, perennial ryegrass, rye, and timothy grass. However, these allergens were irrelevant in the SSA population: no AD patient or HC subject was sensitized to the tested grass pollen.</p><p>The considerably different sensitization patterns between European and SSA AD patients warrant the development of allergy testing and desensitization therapies tailored to the African setting. Therefore, there is a need to characterize local pollen types and counts.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"34 2","pages":"46 - 55"},"PeriodicalIF":0.0,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00313-9.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143632414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Requirements for regulatory acceptance of biomarkers 监管机构接受生物标记物的要求
Allergo Journal International Pub Date : 2024-10-17 DOI: 10.1007/s40629-024-00312-w
Hilke Zander, Jörg Engelbergs
{"title":"Requirements for regulatory acceptance of biomarkers","authors":"Hilke Zander,&nbsp;Jörg Engelbergs","doi":"10.1007/s40629-024-00312-w","DOIUrl":"10.1007/s40629-024-00312-w","url":null,"abstract":"<p>Generally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit–risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVDR) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific–regulatory considerations in this complex regulatory field.</p>","PeriodicalId":37457,"journal":{"name":"Allergo Journal International","volume":"33 8","pages":"309 - 312"},"PeriodicalIF":0.0,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40629-024-00312-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142714360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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