胰腺血液生物标志物载脂蛋白 A2 同工型从发现到临床应用。

IF 2.2 4区 医学 Q3 ONCOLOGY
Cancer Biomarkers Pub Date : 2025-03-01 Epub Date: 2025-04-02 DOI:10.1177/18758592251317405
Ayumi Kashiro, Giman Jung, Kazufumi Honda
{"title":"胰腺血液生物标志物载脂蛋白 A2 同工型从发现到临床应用。","authors":"Ayumi Kashiro, Giman Jung, Kazufumi Honda","doi":"10.1177/18758592251317405","DOIUrl":null,"url":null,"abstract":"<p><p>Pancreatic cancer is a rare and refractory cancer, and the development of blood biomarkers for the enrichment of high-risk individuals who have risk factors for pancreatic cancer from the asymptomatic population is an unmet medical need. We identified abnormalities in the C-terminal truncation of the apolipoprotein A2 dimer (apoA2-isoforms: apoA2-i) in the blood of pancreatic cancer patients through proteomic analysis, and we have reported the potential for diagnosing resectable pancreatic cancer by detecting these abnormalities. We successfully developed enzyme-linked immunosorbent assay (ELISA) reagents for measuring apoA2-i for research use only, and then the basic data for diagnosing pancreatic cancer were accumulated by several studies using these reagents. In 2023, ELISA for measuring apoA2-i was regenerated by the regulation under the Japanese Quality Management System (QMS), it received marketing approval in Japan as an <i>in vitro</i> diagnostic (IVD) kit to aid in the diagnosis of pancreatic cancer, and it is now used in clinical practice. This review chronicles the journey from the initial discovery through omics research, to demonstrating clinical utility via multicenter studies in Japan and international collaborative research using the research reagent and validating the clinical performance of the IVD ELISA kit through a regulatory, science-guided, clinical trial in Japan, and finally to recent activities in the USA.</p>","PeriodicalId":56320,"journal":{"name":"Cancer Biomarkers","volume":"42 3","pages":"18758592251317405"},"PeriodicalIF":2.2000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"From discovery to clinical implementation of a pancreatic blood biomarker, apolipoprotein A2 isoform.\",\"authors\":\"Ayumi Kashiro, Giman Jung, Kazufumi Honda\",\"doi\":\"10.1177/18758592251317405\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Pancreatic cancer is a rare and refractory cancer, and the development of blood biomarkers for the enrichment of high-risk individuals who have risk factors for pancreatic cancer from the asymptomatic population is an unmet medical need. We identified abnormalities in the C-terminal truncation of the apolipoprotein A2 dimer (apoA2-isoforms: apoA2-i) in the blood of pancreatic cancer patients through proteomic analysis, and we have reported the potential for diagnosing resectable pancreatic cancer by detecting these abnormalities. We successfully developed enzyme-linked immunosorbent assay (ELISA) reagents for measuring apoA2-i for research use only, and then the basic data for diagnosing pancreatic cancer were accumulated by several studies using these reagents. In 2023, ELISA for measuring apoA2-i was regenerated by the regulation under the Japanese Quality Management System (QMS), it received marketing approval in Japan as an <i>in vitro</i> diagnostic (IVD) kit to aid in the diagnosis of pancreatic cancer, and it is now used in clinical practice. This review chronicles the journey from the initial discovery through omics research, to demonstrating clinical utility via multicenter studies in Japan and international collaborative research using the research reagent and validating the clinical performance of the IVD ELISA kit through a regulatory, science-guided, clinical trial in Japan, and finally to recent activities in the USA.</p>\",\"PeriodicalId\":56320,\"journal\":{\"name\":\"Cancer Biomarkers\",\"volume\":\"42 3\",\"pages\":\"18758592251317405\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Biomarkers\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/18758592251317405\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Biomarkers","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/18758592251317405","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/2 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

胰腺癌是一种罕见的难治性癌症,从无症状人群中富集具有胰腺癌危险因素的高危个体的血液生物标志物是尚未满足的医疗需求。我们通过蛋白质组学分析发现了胰腺癌患者血液中载脂蛋白A2二聚体(apoa2 -异构体:apoA2-i)的c端截断异常,并报道了通过检测这些异常来诊断可切除胰腺癌的可能性。我们成功开发了用于检测apoA2-i的酶联免疫吸附试验(ELISA)试剂,仅供研究使用,并利用这些试剂进行了多次研究,积累了诊断胰腺癌的基础数据。2023年,用于测定apoA2-i的ELISA在日本质量管理体系(QMS)的监管下获得了再生,它在日本获得了上市许可,作为一种体外诊断(IVD)试剂盒,帮助诊断胰腺癌,现在已用于临床实践。这篇综述记录了从最初的发现到组学研究,到通过日本的多中心研究和国际合作研究使用研究试剂证明临床效用,并通过日本的监管,科学指导的临床试验验证IVD ELISA试剂盒的临床性能,最后到最近在美国的活动。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
From discovery to clinical implementation of a pancreatic blood biomarker, apolipoprotein A2 isoform.

Pancreatic cancer is a rare and refractory cancer, and the development of blood biomarkers for the enrichment of high-risk individuals who have risk factors for pancreatic cancer from the asymptomatic population is an unmet medical need. We identified abnormalities in the C-terminal truncation of the apolipoprotein A2 dimer (apoA2-isoforms: apoA2-i) in the blood of pancreatic cancer patients through proteomic analysis, and we have reported the potential for diagnosing resectable pancreatic cancer by detecting these abnormalities. We successfully developed enzyme-linked immunosorbent assay (ELISA) reagents for measuring apoA2-i for research use only, and then the basic data for diagnosing pancreatic cancer were accumulated by several studies using these reagents. In 2023, ELISA for measuring apoA2-i was regenerated by the regulation under the Japanese Quality Management System (QMS), it received marketing approval in Japan as an in vitro diagnostic (IVD) kit to aid in the diagnosis of pancreatic cancer, and it is now used in clinical practice. This review chronicles the journey from the initial discovery through omics research, to demonstrating clinical utility via multicenter studies in Japan and international collaborative research using the research reagent and validating the clinical performance of the IVD ELISA kit through a regulatory, science-guided, clinical trial in Japan, and finally to recent activities in the USA.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Cancer Biomarkers
Cancer Biomarkers ONCOLOGY-
CiteScore
5.20
自引率
3.20%
发文量
195
审稿时长
3 months
期刊介绍: Concentrating on molecular biomarkers in cancer research, Cancer Biomarkers publishes original research findings (and reviews solicited by the editor) on the subject of the identification of markers associated with the disease processes whether or not they are an integral part of the pathological lesion. The disease markers may include, but are not limited to, genomic, epigenomic, proteomics, cellular and morphologic, and genetic factors predisposing to the disease or indicating the occurrence of the disease. Manuscripts on these factors or biomarkers, either in altered forms, abnormal concentrations or with abnormal tissue distribution leading to disease causation will be accepted.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信