{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T12:24:30Z","timestamp":1774614270282,"version":"3.50.1"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T00:00:00Z","timestamp":1647820800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>OncoMasTR is a recently developed multigene prognostic test for early-stage breast cancer. The test has been developed in a kit-based format for decentralized deployment in molecular pathology laboratories. The analytical performance characteristics of the OncoMasTR test are described in this study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Expression levels of 6 genes were measured by 1-step reverse transcription-quantitative PCR on RNA samples prepared from formalin-fixed, paraffin-embedded (FFPE) breast tumor specimens. Assay precision, reproducibility, input range, and interference were determined using FFPE-derived RNA samples representative of low and high prognostic risk scores. A pooled RNA sample derived from 6 FFPE breast tumor specimens was used to establish the linear range, limit of detection, and amplification efficiency of the individual gene expression assays.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The overall precision of the OncoMasTR test was high with an SD of 0.16, which represents less than 2% of the 10-unit risk score range. Test results were reproducible across 4 testing sites, with correlation coefficients of 0.94 to 0.96 for the continuous risk score and concordance of 86% to 96% in low-\/high-risk sample classification. Consistent risk scores were obtained across a &amp;gt; 100-fold RNA input range. Individual gene expression assays were linear up to quantification cycle values of 36.0 to 36.9, with amplification efficiencies of 80% to 102%. Test results were not influenced by agents used during RNA isolation, by low levels of copurified genomic DNA, or by moderate levels of copurified adjacent nontumor tissue.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The OncoMasTR prognostic test displays robust analytical performance that is suitable for deployment by local pathology laboratories for decentralized use.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/clinchem\/hvac028","type":"journal-article","created":{"date-parts":[[2022,2,7]],"date-time":"2022-02-07T20:11:37Z","timestamp":1644264697000},"page":"837-847","source":"Crossref","is-referenced-by-count":6,"title":["Analytical Validation of a Novel 6-Gene Signature for Prediction of Distant Recurrence in Estrogen Receptor-Positive, HER2-Negative, Early-Stage Breast Cancer"],"prefix":"10.1093","volume":"68","author":[{"given":"Tony","family":"Loughman","sequence":"first","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Barron","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chan-Ju Angel","family":"Wang","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Dynoodt","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bozena","family":"Fender","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cesar","family":"Lopez-Ruiz","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon","family":"Stapleton","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aurelie","family":"Fabre","sequence":"additional","affiliation":[{"name":"Department of Histopathology, St Vincent's University Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cecily","family":"Quinn","sequence":"additional","affiliation":[{"name":"Department of Histopathology, St Vincent's University Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bjorn","family":"Nodin","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences Lund, Division of Oncology and Therapeutic Pathology, Lund University , Lund, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Jirstr\u00f6m","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences Lund, Division of Oncology and Therapeutic Pathology, Lund University , Lund, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fatemeh","family":"Razmara","sequence":"additional","affiliation":[{"name":"Department of Pathology, RCSI Education & Research Centre, Beaumont Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony","family":"O\u2019Grady","sequence":"additional","affiliation":[{"name":"Department of Pathology, RCSI Education & Research Centre, Beaumont Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Marie","family":"Baird","sequence":"additional","affiliation":[{"name":"Trinity Translational Medicine Institute, Trinity Centre for Health Sciences, Trinity College Dublin, St. James\u2019s Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven G","family":"Gray","sequence":"additional","affiliation":[{"name":"Trinity Translational Medicine Institute, Trinity Centre for Health Sciences, Trinity College Dublin, St. James\u2019s Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Freixo","sequence":"additional","affiliation":[{"name":"Department of Pathology, University Medical Centre Utrecht , Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cathy B","family":"Moelans","sequence":"additional","affiliation":[{"name":"Department of Pathology, University Medical Centre Utrecht , Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul J","family":"van Diest","sequence":"additional","affiliation":[{"name":"Department of Pathology, University Medical Centre Utrecht , Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J","family":"Duffy","sequence":"additional","affiliation":[{"name":"UCD Clinical Research Centre, St Vincent\u2019s University Hospital , Dublin, Ireland"},{"name":"UCD School of Medicine, UCD Conway Institute, University College Dublin , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Desmond","family":"O\u2019Leary","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Crown","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"},{"name":"Department of Medical Oncology, St Vincent's University Hospital , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian P","family":"Bracken","sequence":"additional","affiliation":[{"name":"Department of Genetics, Trinity College Dublin , Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William M","family":"Gallagher","sequence":"additional","affiliation":[{"name":"OncoMark Limited, NovaUCD , Belfield, Dublin, Ireland"},{"name":"UCD School of Biomolecular and Biomedical Science, UCD Conway Institute, University College Dublin , Belfield, Dublin, Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2022,3,21]]},"reference":[{"key":"2022060107143284400_hvac028-B1","doi-asserted-by":"crossref","first-page":"1836","DOI":"10.1056\/NEJMoa1701830","article-title":"20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years","volume":"377","author":"Pan","year":"2017","journal-title":"N Engl J 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in invasive ductal breast cancer","volume":"99","author":"Talvinen","year":"2008","journal-title":"Br J Cancer"},{"key":"2022060107143284400_hvac028-B8","doi-asserted-by":"crossref","first-page":"e101423","DOI":"10.1371\/journal.pone.0101423","article-title":"ZNF367 inhibits cancer progression and is targeted by miR-195","volume":"9","author":"Jain","year":"2014","journal-title":"PLoS One"},{"key":"2022060107143284400_hvac028-B9","doi-asserted-by":"crossref","first-page":"78","DOI":"10.1016\/j.ejca.2021.04.016","article-title":"Prognostic value of the 6-gene OncoMasTR test in hormone receptor-positive, HER2-negative early-stage breast cancer: comparative analysis with standard clinicopathological factors","volume":"152","author":"Lynch","year":"2021","journal-title":"Eur J Cancer"},{"key":"2022060107143284400_hvac028-B10","doi-asserted-by":"crossref","first-page":"5931","DOI":"10.1158\/1078-0432.CCR-21-1023","article-title":"The OncoMasTR test predicts distant recurrence in estrogen receptor-positive, HER2-negative early-stage breast cancer: a validation study in ABCSG Trial 8","volume":"27","author":"Filipits","year":"2021","journal-title":"Clin Cancer Res"},{"key":"2022060107143284400_hvac028-B11","volume-title":"Evaluation of detection capability for clinical laboratory measurement procedures; approved guideline","author":"CLSI","year":"2012","edition":"2nd ed."},{"key":"2022060107143284400_hvac028-B12","volume-title":"Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline","author":"CLSI","year":"2003"},{"key":"2022060107143284400_hvac028-B13","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1080\/00401706.1969.10490657","article-title":"Procedures for detecting outlying observations in samples","volume":"11","author":"Grubbs","year":"1969","journal-title":"Technometrics"},{"key":"2022060107143284400_hvac028-B14","volume-title":"Evaluation of precision of quantitative measurement procedures; 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testing program for the EndoPredict assay","volume":"460","author":"Denkert","year":"2012","journal-title":"Virchows Arch"},{"key":"2022060107143284400_hvac028-B23","doi-asserted-by":"crossref","first-page":"1446","DOI":"10.1093\/jnci\/djp335","article-title":"Use of archived specimens in evaluation of prognostic and predictive biomarkers","volume":"101","author":"Simon","year":"2009","journal-title":"J Natl Cancer Inst"}],"container-title":["Clinical 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