{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T05:45:31Z","timestamp":1793943931904,"version":"4.8.0"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T00:00:00Z","timestamp":1781654400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T00:00:00Z","timestamp":1781654400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"Menarini Stemline"},{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PI24\/00160"],"award-info":[{"award-number":["PI24\/00160"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004587","name":"Instituto de Salud Carlos III","doi-asserted-by":"publisher","award":["PT23\/00114"],"award-info":[{"award-number":["PT23\/00114"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Mol Diagn Ther"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1007\/s40291-026-00850-9","type":"journal-article","created":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T10:27:25Z","timestamp":1781692045000},"page":"807-820","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Standardized Analytical Verification of ctDNA ESR1 Mutation Testing in Metastatic HR+\/HER2\u2212 Breast Cancer: A European Multicentre Study Using dPCR and NGS-Based Liquid Biopsy"],"prefix":"10.1007","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9989-0290","authenticated-orcid":false,"given":"Federico","family":"Rojo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Guarneri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Fusco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefano","family":"Indraccolo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Vanden Bempt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena Guerini","family":"Rocco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth","family":"Sardinha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isaac","family":"Garc\u00eda-Murillas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riccardo","family":"Adorisio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Boscolo Bragadin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nerea","family":"Carvajal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Pepe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"P\u00e9rez-Buira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Prieto-Potin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Demi","family":"Renders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gianluca","family":"Russo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Scimone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Swift","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantinos","family":"Venetis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Zazo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Umberto","family":"Malapelle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,17]]},"reference":[{"issue":"10","key":"850_CR1","doi-asserted-by":"publisher","first-page":"573","DOI":"10.1038\/nrclinonc.2015.117","volume":"12","author":"R Jeselsohn","year":"2015","unstructured":"Jeselsohn R, Buchwalter G, De Angelis C, Brown M, Schiff R. ESR1 mutations\u2014a mechanism for acquired endocrine resistance in breast cancer. Nat Rev Clin Oncol. 2015;12(10):573\u201383.","journal-title":"Nat Rev Clin Oncol"},{"issue":"10","key":"850_CR2","doi-asserted-by":"publisher","first-page":"1310","DOI":"10.1001\/jamaoncol.2016.1279","volume":"2","author":"S Chandarlapaty","year":"2016","unstructured":"Chandarlapaty S, Chen D, He W, Sung P, Samoila A, You D, et al. Prevalence of ESR1 mutations in cell-free DNA and outcomes in metastatic breast cancer: a secondary analysis of the BOLERO-2 clinical trial. JAMA Oncol. 2016;2(10):1310\u20135.","journal-title":"JAMA Oncol"},{"key":"850_CR3","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1038\/s41523-018-0075-5","volume":"4","author":"Y Kuang","year":"2018","unstructured":"Kuang Y, Siddiqui B, Hu J, Pun M, Cornwell M, Buchwalter G, et al. Unraveling the clinicopathological features driving the emergence of ESR1 mutations in metastatic breast cancer. NPJ Breast Cancer. 2018;4:22.","journal-title":"NPJ Breast Cancer."},{"issue":"11","key":"850_CR4","doi-asserted-by":"publisher","first-page":"1367","DOI":"10.1016\/S1470-2045(22)00555-1","volume":"23","author":"FC Bidard","year":"2022","unstructured":"Bidard FC, Hardy-Bessard AC, Dalenc F, Bachelot T, Pierga JY, de la Motte RT, et al. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022;23(11):1367\u201377.","journal-title":"Lancet Oncol"},{"issue":"3","key":"850_CR5","doi-asserted-by":"publisher","first-page":"599","DOI":"10.1007\/s10549-024-07376-w","volume":"207","author":"MA Bhave","year":"2024","unstructured":"Bhave MA, Quintanilha JCF, Tukachinsky H, Li G, Scott T, Ross JS, et al. Comprehensive genomic profiling of ESR1, PIK3CA, AKT1, and PTEN in HR(+)HER2(-) metastatic breast cancer: prevalence along treatment course and predictive value for endocrine therapy resistance in real-world practice. Breast Cancer Res Treat. 2024;207(3):599\u2013609.","journal-title":"Breast Cancer Res Treat"},{"key":"850_CR6","doi-asserted-by":"publisher","DOI":"10.1186\/s13058-020-1246-5","volume":"22","author":"A Zundelevich","year":"2020","unstructured":"Zundelevich A, Dadiani M, Kahana-Edwin S, Itay A, Sella T, Gadot M, et al. ESR1 mutations are frequent in newly diagnosed metastatic and loco-regional recurrence of endocrine-treated breast cancer and carry worse prognosis. Breast Cancer Res. 2020;22:16.","journal-title":"Breast Cancer Res"},{"key":"850_CR7","doi-asserted-by":"publisher","DOI":"10.1038\/ncomms11579","volume":"7","author":"JM Spoerke","year":"2016","unstructured":"Spoerke JM, Gendreau S, Walter K, Qiu J, Wilson TR, Savage H, et al. Heterogeneity and clinical significance of ESR1 mutations in ER-positive metastatic breast cancer patients receiving fulvestrant. Nat Commun. 2016;7:11579.","journal-title":"Nat Commun"},{"key":"850_CR8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2023.102642","volume":"121","author":"K Venetis","year":"2023","unstructured":"Venetis K, Pepe F, Pescia C, Cursano G, Criscitiello C, Frascarelli C, et al. ESR1 mutations in HR+\/HER2-metastatic breast cancer: enhancing the accuracy of ctDNA testing. Cancer Treat Rev. 2023;121:102642.","journal-title":"Cancer Treat Rev"},{"issue":"313","key":"850_CR9","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aac7551","volume":"7","author":"G Schiavon","year":"2015","unstructured":"Schiavon G, Hrebien S, Garcia-Murillas I, Cutts RJ, Pearson A, Tarazona N, et al. Analysis of ESR1 mutation in circulating tumor DNA demonstrates evolution during therapy for metastatic breast cancer. Sci Transl Med. 2015;7(313):313ra182.","journal-title":"Sci Transl Med"},{"key":"850_CR10","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2024.104427","volume":"201","author":"E Guerini-Rocco","year":"2024","unstructured":"Guerini-Rocco E, Venetis K, Cursano G, Mane E, Frascarelli C, Pepe F, et al. Standardized molecular pathology workflow for ctDNA-based ESR1 testing in HR+\/HER2- metastatic breast cancer. Crit Rev Oncol Hematol. 2024;201:104427.","journal-title":"Crit Rev Oncol Hematol"},{"issue":"28","key":"850_CR11","doi-asserted-by":"publisher","first-page":"3246","DOI":"10.1200\/JCO.22.00338","volume":"40","author":"FC Bidard","year":"2022","unstructured":"Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III EMERALD Trial. J Clin Oncol. 2022;40(28):3246\u201356.","journal-title":"J Clin Oncol"},{"key":"850_CR12","unstructured":"U. S. Food and Drug Administration. United States: United States Government; 2023. [Cited 29 January 2025]. https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer."},{"key":"850_CR13","doi-asserted-by":"publisher","first-page":"3423","DOI":"10.1200\/JCO.23.00638","volume":"41","author":"HJ Burstein","year":"2023","unstructured":"Burstein HJ, DeMichele A, Somerfield MR, Henry NL. Testing for ESR1 mutations to guide therapy for hormone receptor\u2013positive, human epidermal growth factor receptor 2\u2013negative metastatic breast cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2023;41:3423\u20135.","journal-title":"J Clin Oncol"},{"key":"850_CR14","unstructured":"NCCN Clinical Practice Guidelines in Oncology (NCC Guidelines\u00ae). Breast Cancer. Version 6. 2024."},{"issue":"5","key":"850_CR15","doi-asserted-by":"publisher","first-page":"759","DOI":"10.1093\/clinchem\/hvae014","volume":"70","author":"P van der Leest","year":"2024","unstructured":"van der Leest P, Rozendal P, Hinrichs J, van Noesel CJM, Zwaenepoel K, Deiman B, et al. External quality assessment on molecular tumor profiling with circulating tumor DNA-based methodologies routinely used in clinical pathology within the COIN Consortium. Clin Chem. 2024;70(5):759\u201367.","journal-title":"Clin Chem"},{"issue":"1","key":"850_CR16","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1016\/j.jmoldx.2024.08.011","volume":"27","author":"GA Martens","year":"2025","unstructured":"Martens GA, Demol J, Dedeurwaerdere F, De Smet K, Wesolowski J, De Smet D. Surveillance of disease progression in metastatic breast cancer by molecular counting of circulating tumor DNA using plasma-SeqSensei breast cancer in vitro diagnostics assay. J Mol Diagn. 2025;27(1):25\u201335.","journal-title":"J Mol Diagn"},{"key":"850_CR17","unstructured":"COSMIC: Catalogue of Somatic Mutations in Cancer. Hinxton (UK): Welcome Sanger Institute [citado 8 sep 2025]. http:\/\/cancer.sanger.ac.uk\/cosmic."},{"issue":"1","key":"850_CR18","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1186\/s13058-020-1246-5","volume":"22","author":"A Zundelevich","year":"2020","unstructured":"Zundelevich A, Dadiani M, Kahana-Edwin S, et al. ESR1 mutations are frequent in newly diagnosed metastatic and loco-regional recurrence of endocrine-treated breast cancer and carry worse prognosis. Breast Cancer Res. 2020;22(1):16.","journal-title":"Breast Cancer Res"},{"issue":"25","key":"850_CR19","doi-asserted-by":"publisher","first-page":"2961","DOI":"10.1200\/JCO.2016.67.3061","volume":"34","author":"C Fribbens","year":"2016","unstructured":"Fribbens C, O\u2019Leary B, Kilburn L, Hrebien S, Garcia-Murillas I, Beaney M, et al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2016;34(25):2961\u20138.","journal-title":"J Clin Oncol"},{"issue":"3","key":"850_CR20","doi-asserted-by":"publisher","first-page":"556","DOI":"10.3390\/cancers13030556","volume":"13","author":"D Stergiopoulou","year":"2021","unstructured":"Stergiopoulou D, Markou A, Tzanikou E, Ladas I, Makrigiorgos GM, Georgoulias V, et al. ESR1 NAPA Assay: development and analytical validation of a highly sensitive and specific blood-based assay for the detection of ESR1 mutations in liquid biopsies. Cancers (Basel). 2021;13(3):556.","journal-title":"Cancers (Basel)."},{"issue":"7","key":"850_CR21","doi-asserted-by":"publisher","first-page":"974","DOI":"10.1373\/clinchem.2015.238717","volume":"61","author":"DS Guttery","year":"2015","unstructured":"Guttery DS, Page K, Hills A, Woodley L, Marchese SD, Rghebi B, et al. Noninvasive detection of activating estrogen receptor 1 (ESR1) mutations in estrogen receptor-positive metastatic breast cancer. Clin Chem. 2015;61(7):974\u201382.","journal-title":"Clin Chem"},{"issue":"4","key":"850_CR22","doi-asserted-by":"publisher","first-page":"993","DOI":"10.1158\/1078-0432.CCR-15-0943","volume":"22","author":"D Chu","year":"2016","unstructured":"Chu D, Paoletti C, Gersch C, VanDenBerg DA, Zabransky DJ, Cochran RL, et al. ESR1 mutations in circulating plasma tumor DNA from metastatic breast cancer patients. Clin Cancer Res. 2016;22(4):993\u20139.","journal-title":"Clin Cancer Res"},{"issue":"5","key":"850_CR23","doi-asserted-by":"publisher","first-page":"1130","DOI":"10.1158\/1078-0432.CCR-15-1534","volume":"22","author":"P Wang","year":"2016","unstructured":"Wang P, Bahreini A, Gyanchandani R, Lucas PC, Hartmaier RJ, Watters RJ, et al. Sensitive detection of mono- and polyclonal ESR1 mutations in primary tumors, metastatic lesions, and cell-free DNA of breast cancer patients. Clin Cancer Res. 2016;22(5):1130\u20137.","journal-title":"Clin Cancer Res"},{"issue":"6","key":"850_CR24","doi-asserted-by":"publisher","first-page":"540","DOI":"10.1016\/j.trsl.2015.09.003","volume":"166","author":"T Takeshita","year":"2015","unstructured":"Takeshita T, Yamamoto Y, Yamamoto-Ibusuki M, Inao T, Sueta A, Fujiwara S, et al. Droplet digital polymerase chain reaction assay for screening of ESR1 mutations in 325 breast cancer specimens. Transl Res. 2015;166(6):540-53.e2.","journal-title":"Transl Res"},{"issue":"14","key":"850_CR25","doi-asserted-by":"publisher","first-page":"2987","DOI":"10.1038\/s41388-020-1174-y","volume":"39","author":"E Jeannot","year":"2020","unstructured":"Jeannot E, Darrigues L, Michel M, Stern MH, Pierga JY, Rampanou A, et al. A single droplet digital PCR for ESR1 activating mutations detection in plasma. Oncogene. 2020;39(14):2987\u201395.","journal-title":"Oncogene"},{"issue":"21","key":"850_CR26","doi-asserted-by":"publisher","first-page":"5004","DOI":"10.1093\/nar\/26.21.5004","volume":"26","author":"U Giesen","year":"1998","unstructured":"Giesen U, Kleider W, Berding C, Geiger A, Orum H, Nielsen PE. A formula for thermal stability (Tm) prediction of PNA\/DNA duplexes. Nucleic Acids Res. 1998;26(21):5004\u20136.","journal-title":"Nucleic Acids Res"},{"issue":"1","key":"850_CR27","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1007\/s10549-017-4487-y","volume":"167","author":"N Masunaga","year":"2018","unstructured":"Masunaga N, Kagara N, Motooka D, et al. Highly sensitive detection of ESR1 mutations in cell-free DNA from patients with metastatic breast cancer using molecular barcode sequencing. Breast Cancer Res Treat. 2018;167(1):49\u201358.","journal-title":"Breast Cancer Res Treat"},{"issue":"18","key":"850_CR28","doi-asserted-by":"publisher","first-page":"3423","DOI":"10.1200\/JCO.23.00638","volume":"41","author":"HJ Burstein","year":"2023","unstructured":"Burstein HJ, DeMichele A, Somerfield MR, Henry NL, Biomarker Testing and Endocrine and Targeted Therapy in metastatic Breast Cancer Expert Panels. Testing for ESR1 mutations to guide therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline rapid recommendation update. J Clin Oncol. 2023;41(18):3423\u20135.","journal-title":"J Clin Oncol"},{"issue":"5","key":"850_CR29","doi-asserted-by":"publisher","first-page":"909","DOI":"10.1158\/1055-9965.EPI-18-0586","volume":"28","author":"L Cavallone","year":"2019","unstructured":"Cavallone L, Aldamry M, Lafleur J, Lan C, Gonzalez Ginestet P, Alirezaie N, et al. A study of pre-analytical variables and optimization of extraction method for circulating tumor DNA measurements by digital droplet PCR. Cancer Epidemiol Biomark Prev. 2019;28(5):909\u201316.","journal-title":"Cancer Epidemiol Biomark Prev"},{"issue":"2","key":"850_CR30","doi-asserted-by":"publisher","first-page":"274","DOI":"10.1016\/j.jmoldx.2018.09.003","volume":"21","author":"BC Corless","year":"2019","unstructured":"Corless BC, Chang GA, Cooper S, Syeda MM, Shao Y, Osman I, et al. Development of novel mutation-specific droplet digital PCR assays detecting TERT promoter mutations in tumor and plasma samples. J Mol Diagn. 2019;21(2):274\u201385.","journal-title":"J Mol Diagn"},{"issue":"22","key":"850_CR31","doi-asserted-by":"publisher","first-page":"8604","DOI":"10.1021\/ac202028g","volume":"83","author":"BJ Hindson","year":"2011","unstructured":"Hindson BJ, Ness KD, Masquelier DA, Belgrader P, Heredia NJ, Makarewicz AJ, et al. High-throughput droplet digital PCR system for absolute quantitation of DNA copy number. Anal Chem. 2011;83(22):8604\u201310.","journal-title":"Anal Chem"},{"issue":"11","key":"850_CR32","doi-asserted-by":"publisher","first-page":"2221","DOI":"10.1002\/1878-0261.13523","volume":"17","author":"B Leatham","year":"2023","unstructured":"Leatham B, McNall K, Subramanian HKK, Jacky L, Alvarado J, Yurk D, et al. A rapid, multiplex digital PCR assay to detect gene variants and fusions in non-small cell lung cancer. Mol Oncol. 2023;17(11):2221\u201334.","journal-title":"Mol Oncol"},{"issue":"4","key":"850_CR33","doi-asserted-by":"publisher","first-page":"223","DOI":"10.1038\/nrc.2017.7","volume":"17","author":"JCM Wan","year":"2017","unstructured":"Wan JCM, Massie C, Garcia-Corbacho J, Mouliere F, Brenton JD, Caldas C, et al. Liquid biopsies come of age: towards implementation of circulating tumour DNA. Nat Rev Cancer. 2017;17(4):223\u201338.","journal-title":"Nat Rev Cancer"},{"key":"850_CR34","doi-asserted-by":"crossref","unstructured":"Rojo F, Meier L, Mart\u00ednez MT, Esteban L\u00f3pez M, Paris L, O'Connor M, et al. Plasma mutational burden in PIK3CA and TP53 independently predicts early progression in patients with HR+\/HER2- metastatic breast cancer (MBC) enrolled in the GEICAM\/2014-12 FLIPPER trial. J Clin Oncol 2024; 42 (16 suppl). Meeting abstract: 2024 Asco Annual Meeting.","DOI":"10.1200\/JCO.2024.42.16_suppl.1029"},{"key":"850_CR35","doi-asserted-by":"crossref","unstructured":"Guerrero-Zotano A, Antol\u00edn S, Tibau Martorell A, Cruz-Jurado J, Andr\u00e9s R, Saura S, et al. Frequency and prognostic significance of ESR1 mutations post-CDK4\/6 inhibitors in ER+\/HER2\u2212 metastatic breast cancer: real-world data from the GEICAM_RegistEM study. Clin Cancer Res 2026; 32 (4_Supplement): PS1-12-17. Meeting abstract: 2025 SABCS.","DOI":"10.1158\/1557-3265.SABCS25-PS1-12-17"},{"key":"850_CR36","doi-asserted-by":"crossref","unstructured":"Rojo F, Guarneri V, Boscolo Bragadin A, Indraccolo S, Guerini Rocco E, Fusco N, et al. Real-world study of ESR1 mutation testing by liquid biopsy using digital PCR or NGS to guide elacestrant use in metastatic breast cancer patients. ESMO Open 2025; Vol 10 (Suppl 4): 76P. Meeting abstract: ESMO Breast Cancer Congress 2025","DOI":"10.1016\/j.esmoop.2025.104630"}],"container-title":["Molecular Diagnosis &amp; Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40291-026-00850-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40291-026-00850-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40291-026-00850-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T06:31:47Z","timestamp":1787380307000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40291-026-00850-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,17]]},"references-count":36,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["850"],"URL":"https:\/\/doi.org\/10.1007\/s40291-026-00850-9","relation":{},"ISSN":["1177-1062","1179-2000"],"issn-type":[{"value":"1177-1062","type":"print"},{"value":"1179-2000","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,17]]},"assertion":[{"value":"22 December 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 April 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 June 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was supported by a research grant from Menarini Stemline. The sponsor had no role in study design, data collection, data analysis, data interpretation, or manuscript preparation. The open access publication fee was funded by Menarini Stemline. FR receives grants from the Spanish Government and cofinanced by FEDER Funds (AES Program PI24\/00160, PT23\/00114).","order":1,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"FR: Speaker\/advisory role: Astra Zeneca, BMS, Roche, MSD, Abbvie, Merck, Lilly, Menarini-Stemline, Janssen, Novartis, GSK, Agilent, Sophia Genetics, Daiichi-Sankyo, Pfizer, Astellas, BeiGene, Gilead. Research funding: Astra Zeneca, Menarini-Stemline, Pfizer, Roche, Astellas. VG: Speaker\/advisory role: Eli Lilly, Daiichi Sankyo, GSK, Gilead, Novartis, Exact sciences, Roche, Astra Zeneca, Menarini Stemline, Zentiva, Abbvie, Pfizer, MSD. NF: Consulting\/advisory role: Abbvie, Alira Health, AstraZeneca, Epredia, Gilead, Menarini Group, Merck, MSD, Novartis, Pfizer, Roche, Sakura, Sysmex, Veracyte. Speaker bureau: AstraZeneca, Daiichi Sankyo, Epredia, Exact Sciences, Gilead, GSK, Leica Biosystems, Lilly, Menarini Group, MSD, Novartis, Roche, Sysmex, ThermoFisher, Veracyte. Research support: AstraZeneca, Gilead, GSK, Novartis, Owkin, Pfizer, Pillar Biosciences. Travel support: AstraZeneca, Novartis, Roche. SI: Speaker\/advisory: Dephaforum, Menarini-Steamline. Research funding: Menarini-Stemline. IVB: Speaker\/advisory role: Astra Zeneca, Roche, Menarini-Stemline, Janssen, MSD. Research funding: Menarini-Stemline. EGR: Advisory fees, honoraria, travel accommodation and expenses, grants and non-financial support:AbbVie, AstraZeneca, Exact Sciences, GSK, Illumina, Lilly, Novartis, MSD, Pfizer, Roche, Sophia Genetics, Stemline (Menarini), Thermo Fisher Scientific. RS: Meetings and\/or travel: Menarini-Stemline. IGM: Consulting fees: Bio-Rad. Honoraria or lectures: Lilly, Eisai. Attending meetings\/travels: Bio-Rad, Menarini-Stemline, Lilly. RA: Declare no conflict of interest. ABB: Speaker\/advisory role: Sysmex. NC: Speaker\/advisory: Astra Zeneca, MSD, Menarini-Stemline. Research funding: Menarini-Stemline. FP: Personal fees (consultant and\/or speaker bureau): Menarini, Thermofisher, Jansen, Roche\u00a0unrelated to the current work. SPB: Speaker\/advisory: Astra Zeneca, MSD, Menarini-Stemline. Research funding: Menarini-Stemline. IPP: Speaker\/advisory role: Menarini-Steamline, Sysmex-Europe. Research funding: Menarini-Stemline. DR: Support for attending meetings and\/or travel: Menarini-Stemline. GR: Declares no conflict of interest. CSc: Declares no conflict of interest. CSw: Meetings and\/or travel: Menarini-Stemline. KD: Declares no conflict of interest. SZ: Speaker\/advisory: Astra Zeneca, MSD, Menarini-Stemline. Research funding: Menarini Stemline. UM: personal fees (as consultant and\/or speaker bureau): Boehringer Ingelheim, Roche, MSD, Amgen, Thermo Fisher Scientific, Eli Lilly, Diaceutics, GSK, Merck and AstraZeneca, Janssen, Diatech, Novartis and Hedera unrelated to the current work. Umberto Malapelle is an Editorial Board member of Molecular Diagnosis & Therapy. Umberto Malapelle was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.","order":2,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent (Participation and Publication)","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Conceptualization: F.R., U.M. Methodology, validation, and formal analysis: all authors. Supervision: F.R., U.M. Writing\u2014review and editing: all authors. All authors have read and approved the final version of the article.","order":5,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":6,"name":"Ethics","label":"Data Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}}]}}