{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:34:07Z","timestamp":1786977247561,"version":"build-2736575974"},"reference-count":27,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T00:00:00Z","timestamp":1751587200000},"content-version":"vor","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Formalin\u2010fixed paraffin\u2010embedded (FFPE) tissue is the standard material for companion diagnostic tests (CDx). Although cytological specimens can be useful, their low tumor content (TC) poses challenges. Recently, a high\u2010sensitivity CDx, the \u201cLung Cancer Compact Panel (cPANEL),\u201d with a recommended TC of 5%, was introduced into clinical practice. This CDx achieves high detection sensitivity by selecting specific genes for analysis, processing them separately, and performing sequence at sufficient depth. This approach enables the detection of mutations even when they are present in only small amounts within the sample. This study aimed to evaluate the utility of cPANEL using FFPE cell block (CB) with a low TC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed FFPE\u2010CB pleural fluid samples from 26 patients diagnosed with malignant pleural effusion originating from lung adenocarcinoma. TC was quantified using AI\u2010equipped image analysis software, and samples with a TC of less than 10%\u2014the minimum threshold for single\u2010CDx\u2014were selected for CDx analysis. To confirm that cPANEL has better sensitivity than single\u2010CDx, which has high detection power, and that it is advantageous in low TC samples such as FFPE\u2010CB, we compared the two CDx assays based on the EGFR\u2010positive rate using samples that did not meet the TC criterion for single\u2010CDx.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Most FFPE\u2010CB had low TC levels, with only approximately 27% meeting the TC criteria for the widely used multi\u2010CDx. Furthermore, over 60% of the samples fell below the 10% threshold for a single\u2010CDx. Despite the low TC, EGFR mutations were partially detected, with cPANEL achieving a higher detection rate than that of single\u2010CDx (68.8% vs. 50.0%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although cPANEL is classified as a multi\u2010CDx, it demonstrated superior sensitivity compared with that of single\u2010CDx. It proved effective even for FFPE\u2010CB samples with very low TC, making it a promising tool to enhance the use of cytological samples for CDx in the future.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.71028","type":"journal-article","created":{"date-parts":[[2025,7,5]],"date-time":"2025-07-05T02:53:59Z","timestamp":1751684039000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Utility of a Novel High\u2010Sensitivity Multiplex Companion Diagnostic Test Using Formalin\u2010Fixed Paraffin\u2010Embedded Cell Block Materials of Non\u2010small\u00a0Cell Lung Cancer"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-0489-535X","authenticated-orcid":false,"given":"Yoshiki","family":"Shinomiya","sequence":"first","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Ishida","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanako C.","family":"Hatanaka","sequence":"additional","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamiko","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayae","family":"Nange","sequence":"additional","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asami","family":"Okumura","sequence":"additional","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumi","family":"Wada","sequence":"additional","affiliation":[{"name":"Center for Development of Advanced Diagnostics, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuharu","family":"Abiko","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryoko","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yamato","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiharu","family":"Sato","sequence":"additional","affiliation":[{"name":"DNA Chip Research Inc.  Kawasaki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4333-8100","authenticated-orcid":false,"given":"Jun","family":"Sakakibara\u2010Konishi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Faculty of Medicine, Hokkaido University  Sapporo Japan"},{"name":"Medical Network and Welfare Center, Hokkaido University Hospital  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Thoracic Surgery Hokkaido University Graduate School of Medicine  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital  Sapporo Japan"},{"name":"Department of Cancer Pathology Faculty of Medicine, Hokkaido University  Sapporo Japan"},{"name":"Institute for 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