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The study aims to establish and validate a new enzyme-linked immunosorbent sandwich assay under Japanese medical device quality management requirements, followed by in vitro diagnostic testing using prespecified endpoints with 2732 plasma samples. Diagnostic performance was compared with CA19-9, showing higher AUC and primary endpoint achievement for apoA2-ATQ/AT, with improved sensitivity when combined.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/clinical-development-of-a-blood-biomarker-using-apolipoprotein-a2-isoforms-for-early-detection-of-pancreatic-cancer/340961/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/clinical-development-of-a-blood-biomarker-using-apolipoprotein-a2-isoforms-for-early-detection-of-pancreatic-cancer/340961.png","ImageObject",300,407,{"name":92,"@type":93},"Anda","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-22",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the study’s primary goal for apoA2 isoforms?","Question",{"text":112,"@type":113},"To clinically develop apolipoprotein A2 isoforms as candidate plasma biomarkers for early-stage pancreatic cancer.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was apoA2-is measured in this study?",{"text":117,"@type":113},"A new enzyme-linked immunosorbent sandwich assay was established for apoA2-is under Japanese medical device Quality Management System requirements, followed by in vitro diagnostic testing.",{"name":119,"@type":110,"acceptedAnswer":120},"How did apoA2-ATQ/AT perform compared with CA19-9?",{"text":121,"@type":113},"The area under the curve and the primary endpoint distinguished pancreatic cancer from healthy controls with higher performance for apoA2-ATQ/AT, and the combination with CA19-9 increased sensitivity further.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},340961,1790126117,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":36},962075006959,"https://ap-avatar.wpscdn.com/avatar/e0002397efbe92a78e?_k=1776741047341049297","J Gastroenterol (2024) 59:263–278  \n[https://doi.org/10.1007/s00535-023-02072-w](https://doi.org/10.1007/s00535-023-02072-w)  \nORIGINAL ARTICLE―LIVER, PANCREAS, AND BILIARY TRACT  \nClinical development of a blood biomarker using apolipoprotein‑A2 isoforms for early detection of pancreatic cancer  \nAyumi Kashiro1,2 · Michimoto Kobayashi3 · Takanori Oh3 · Mitsuko Miyamoto3 · Jun Atsumi3 · Kengo Nagashima4 · Keiko Takeuchi2 · Satoshi Nara5 · Susumu Hijioka6 · Chigusa Morizane6 · Shojiro Kikuchi7 · Shingo Kato8 · Ken Kato9 · Hiroki Ochiai10 · Daisuke Obata11 · Yuya Shizume3 · Hiroshi Konishi12 · Yumiko Nomura12 ·  \nKotone Matsuyama13 · Cassie Xie14 · Christin Wong15 · Ying Huang14 · Giman Jung15 · Sudhir Srivastava16,17 · Hiromu Kutsumi11 · Kazufumi Honda1,2  \nReceived: 10 July 2023 / Accepted: 26 December 2023 / Published online: 23 January 2024 © The Author(s) 2024  \nAbstract  \nBackground We have previously reported apolipoprotein A2-isoforms (apoA2-is) as candidate plasma biomarkers for early-stage pancreatic cancer. The aim of this study was the clinical development of apoA2-is.  \nMethods We established a new enzyme-linked immunosorbent sandwich assay for apoA2-is under the Japanese medical device Quality Management System requirements and performed in vitro diagnostic tests with prespecified end  \nSupplementary Information The online version contains supplementary material available at [https://doi.org/10.1007/](https://doi.org/10.1007/)[ ](https://doi.org/10.1007/)s00535-023-02072-w.  \n* Kazufumi Honda [k-honda@nms.ac.jp](k-honda@nms.ac.jp)  \n1 Department of Bioregulation, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo 113-8602, Japan  \n2 Institute for Advanced Medical Sciences, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo 113-8602, Japan  \n3 Toray Industries, Inc., 2-1-1 Muromachi Nihonbashi, Chuo-Ku, Tokyo 103-8666, Japan  \n4 Keio University Hospital, 35 Shinanomachi, Shinjuku-Ku, Tokyo 160-8582, Japan  \n5 Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan  \n6 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan  \n7 Institute of Advanced Medical Sciences, Hyogo Medical University, 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501, Japan  \npoints using 2732 plasma samples. The clinical equivalence and significance of apoA2-is were compared with CA19-9 . Results The point estimate of the area under the curve to distinguish between pancreatic cancer (n = 106) and healthy controls (n = 106) was higher for apoA2-ATQ/AT [0.879, 95% confidence interval (CI): 0.832–0.925] than for CA19-9 (0.849, 95% CI 0.793–0.905) and achieved the primary endpoint. The cutoff apoA2-ATQ/AT of 59.5 μg/mL was defined based on a specificity of 95% in 2000 healthy samples, and the reliability of specificities was confirmed in two independent healthy cohorts as 95.3%(n = 106, 95% CI 89.4– 98.0%) and 95 .8%(n = 400, 95% CI 93 .3–97.3%) . The sensitivities of apoA2-ATQ/AT for detecting both stage I (47.4%)  \n8 Department of Clinical Cancer Genomics, Yokohama City University Hospital, 3-9 Fukuura, Kanazawa-Ku, Yokohama, Kanagawa 236-0004, Japan  \n9 Department of Head and Neck Esophageal Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan  \n10 Department of Gastroenterological Surgery, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan  \n11 Center for Clinical Research and Advanced Medicine, Shiga University of Medical Science, Tsukiwamachi Seta, Otsu, Shiga 520-2192, Japan  \n12 Japan Cancer Society, 5-3-3 Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan  \n13 Department of Health Policy and Management, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo 113-8602, Japan  \n14 Biostatistics, Bioinformatics and Epidemiology Program, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Cent","cbCaiaugLkxz85wf","https://ap.wps.com/l/cbCaiaugLkxz85wf","pdf",750727,16,"English","# Abstract\n## Background\n## Methods\n## Results\n## Conclusions\n## Keywords\n# Abbreviations\n# Background","[{\"question\":\"What was the study’s primary goal for apoA2 isoforms?\",\"answer\":\"To clinically develop apolipoprotein A2 isoforms as candidate plasma biomarkers for early-stage pancreatic cancer.\"},{\"question\":\"How was apoA2-is measured in this study?\",\"answer\":\"A new enzyme-linked immunosorbent sandwich assay was established for apoA2-is under Japanese medical device Quality Management System requirements, followed by in vitro diagnostic testing.\"},{\"question\":\"How did apoA2-ATQ/AT perform compared with CA19-9?\",\"answer\":\"The area under the curve and the primary endpoint distinguished pancreatic cancer from healthy controls with higher performance for apoA2-ATQ/AT, and the combination with CA19-9 increased sensitivity further.\"}]","Clinical development of a blood biomarker using apolipoprotein-A2 isoforms for early detection of pancreatic cancer | PDF",1790039701]