Michael E Hodsdon, Adam Abel, Antonio Chambers, Ming Lu, Amanda Morris, Michael J Pontecorvo, Heinz Reiske, Samantha C Burnham, Emily C Collins, Mark Mintun, Andrew Schade, Rose C Beck
{"title":"礼来SP-X P-tau217检测的临床验证：在代表性不足的队列中的表现","authors":"Michael E Hodsdon, Adam Abel, Antonio Chambers, Ming Lu, Amanda Morris, Michael J Pontecorvo, Heinz Reiske, Samantha C Burnham, Emily C Collins, Mark Mintun, Andrew Schade, Rose C Beck","doi":"10.1002/dad2.70139","DOIUrl":null,"url":null,"abstract":"<p><strong>Inroduction: </strong>Plasma phosphorylated tau217 (p-tau217) is a biomarker for the detection of amyloid pathology. We present performance characteristics of the Lilly SP-X P-tau217 assay in a clinical validation cohort, as a whole and divided into subpopulations from traditionally underrepresented groups.</p><p><strong>Methods: </strong>We measured p-tau217 levels in plasma samples from participants with mild cognitive impairment. Assay performance in predicting positivity for amyloid beta (Aβ) positron emission tomography was examined using two numerical cutoffs.</p><p><strong>Results: </strong>Two p-tau217 cutoffs were determined with an upper-level group with 95% positive predictive value for Aβ positivity and a lower-level group with 84% negative predictive value for Aβ negativity, with 91% sensitivity and 90% specificity. The remaining indeterminate group represented 18% of participant samples. Similar performance was observed across validation subgroups.</p><p><strong>Discussion: </strong>The validation data support the potential clinical utility of the SP-X p-tau217 assay in multiple subpopulations to aid in Alzheimer's disease diagnosis.</p><p><strong>Highlights: </strong>The Lilly SP-X p-tau217 assay showed strong concordance with amyloid PET in total cohort and underrepresented groups.Assay performance is in line with guidance from the Global CEOi on AD Working Group.Data support the clinical utility of the assay in multiple cohorts to aid in AD diagnosis.</p>","PeriodicalId":53226,"journal":{"name":"Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring","volume":"17 3","pages":"e70139"},"PeriodicalIF":4.0000,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12206948/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinical validation of the Lilly SP-X P-tau217 assay: Performance in underrepresented cohorts.\",\"authors\":\"Michael E Hodsdon, Adam Abel, Antonio Chambers, Ming Lu, Amanda Morris, Michael J Pontecorvo, Heinz Reiske, Samantha C Burnham, Emily C Collins, Mark Mintun, Andrew Schade, Rose C Beck\",\"doi\":\"10.1002/dad2.70139\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Inroduction: </strong>Plasma phosphorylated tau217 (p-tau217) is a biomarker for the detection of amyloid pathology. We present performance characteristics of the Lilly SP-X P-tau217 assay in a clinical validation cohort, as a whole and divided into subpopulations from traditionally underrepresented groups.</p><p><strong>Methods: </strong>We measured p-tau217 levels in plasma samples from participants with mild cognitive impairment. Assay performance in predicting positivity for amyloid beta (Aβ) positron emission tomography was examined using two numerical cutoffs.</p><p><strong>Results: </strong>Two p-tau217 cutoffs were determined with an upper-level group with 95% positive predictive value for Aβ positivity and a lower-level group with 84% negative predictive value for Aβ negativity, with 91% sensitivity and 90% specificity. The remaining indeterminate group represented 18% of participant samples. Similar performance was observed across validation subgroups.</p><p><strong>Discussion: </strong>The validation data support the potential clinical utility of the SP-X p-tau217 assay in multiple subpopulations to aid in Alzheimer's disease diagnosis.</p><p><strong>Highlights: </strong>The Lilly SP-X p-tau217 assay showed strong concordance with amyloid PET in total cohort and underrepresented groups.Assay performance is in line with guidance from the Global CEOi on AD Working Group.Data support the clinical utility of the assay in multiple cohorts to aid in AD diagnosis.</p>\",\"PeriodicalId\":53226,\"journal\":{\"name\":\"Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring\",\"volume\":\"17 3\",\"pages\":\"e70139\"},\"PeriodicalIF\":4.0000,\"publicationDate\":\"2025-06-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12206948/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/dad2.70139\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Alzheimer''s and Dementia: Diagnosis, Assessment and Disease Monitoring","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/dad2.70139","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Clinical validation of the Lilly SP-X P-tau217 assay: Performance in underrepresented cohorts.
Inroduction: Plasma phosphorylated tau217 (p-tau217) is a biomarker for the detection of amyloid pathology. We present performance characteristics of the Lilly SP-X P-tau217 assay in a clinical validation cohort, as a whole and divided into subpopulations from traditionally underrepresented groups.
Methods: We measured p-tau217 levels in plasma samples from participants with mild cognitive impairment. Assay performance in predicting positivity for amyloid beta (Aβ) positron emission tomography was examined using two numerical cutoffs.
Results: Two p-tau217 cutoffs were determined with an upper-level group with 95% positive predictive value for Aβ positivity and a lower-level group with 84% negative predictive value for Aβ negativity, with 91% sensitivity and 90% specificity. The remaining indeterminate group represented 18% of participant samples. Similar performance was observed across validation subgroups.
Discussion: The validation data support the potential clinical utility of the SP-X p-tau217 assay in multiple subpopulations to aid in Alzheimer's disease diagnosis.
Highlights: The Lilly SP-X p-tau217 assay showed strong concordance with amyloid PET in total cohort and underrepresented groups.Assay performance is in line with guidance from the Global CEOi on AD Working Group.Data support the clinical utility of the assay in multiple cohorts to aid in AD diagnosis.
期刊介绍：
Alzheimer''s & Dementia: Diagnosis, Assessment & Disease Monitoring (DADM) is an open access, peer-reviewed, journal from the Alzheimer''s Association® that will publish new research that reports the discovery, development and validation of instruments, technologies, algorithms, and innovative processes. Papers will cover a range of topics interested in the early and accurate detection of individuals with memory complaints and/or among asymptomatic individuals at elevated risk for various forms of memory disorders. The expectation for published papers will be to translate fundamental knowledge about the neurobiology of the disease into practical reports that describe both the conceptual and methodological aspects of the submitted scientific inquiry. Published topics will explore the development of biomarkers, surrogate markers, and conceptual/methodological challenges. Publication priority will be given to papers that 1) describe putative surrogate markers that accurately track disease progression, 2) biomarkers that fulfill international regulatory requirements, 3) reports from large, well-characterized population-based cohorts that comprise the heterogeneity and diversity of asymptomatic individuals and 4) algorithmic development that considers multi-marker arrays (e.g., integrated-omics, genetics, biofluids, imaging, etc.) and advanced computational analytics and technologies.
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