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Analytical Validati...
Analytical Validation of a Novel 6-Gene Signature for Prediction of Distant Recurrence in Estrogen Receptor-Positive, HER2-Negative, Early-Stage Breast Cancer
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- Loughman, Tony (författare)
- OncoMark Limited
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- Barron, Stephen (författare)
- OncoMark Limited
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- Wang, Chan-Ju Angel (författare)
- OncoMark Limited
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- Dynoodt, Peter (författare)
- OncoMark Limited
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- Fender, Bozena (författare)
- OncoMark Limited
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- Lopez-Ruiz, Cesar (författare)
- OncoMark Limited
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- Stapleton, Sharon (författare)
- OncoMark Limited
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- Fabre, Aurelie (författare)
- St Vincent's University Hospital
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- Quinn, Cecily (författare)
- St Vincent's University Hospital
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- Nodin, Björn (författare)
- Lund University,Lunds universitet,Personlig patologi och cancerbehandling,Forskargrupper vid Lunds universitet,Personalized Pathology & Cancer Therapy,Lund University Research Groups
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- Jirström, Karin (författare)
- Lund University,Lunds universitet,Terapeutisk patologi,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Therapeutic pathology,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,LUCC: Lund University Cancer Centre,Other Strong Research Environments
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- Razmara, Fatemeh (författare)
- Beaumont Hospital, Dublin
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- O’Grady, Anthony (författare)
- Beaumont Hospital, Dublin
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- Baird, Anne-Marie (författare)
- Trinity Translational Medicine Institute
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- Gray, Steven G. (författare)
- Trinity Translational Medicine Institute
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- Freixo, Ana (författare)
- University Medical Center Utrecht
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- Moelans, Cathy B. (författare)
- University Medical Center Utrecht
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- van Diest, Paul J. (författare)
- University Medical Center Utrecht
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- Duffy, Michael J. (författare)
- St Vincent's University Hospital,University College Dublin
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- O’Leary, Desmond (författare)
- OncoMark Limited
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- Crown, John (författare)
- St Vincent's University Hospital,OncoMark Limited
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- Bracken, Adrian P. (författare)
- Trinity College Dublin
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- Gallagher, William M. (författare)
- University College Dublin,OncoMark Limited
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(creator_code:org_t)
- 2022-03-21
- 2022
- Engelska.
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Ingår i: Clinical Chemistry. - : Oxford University Press (OUP). - 0009-9147 .- 1530-8561. ; 68:6, s. 837-847
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- BackgroundOncoMasTR 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.MethodsExpression 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.ResultsThe 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 > 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.ConclusionThe OncoMasTR prognostic test displays robust analytical performance that is suitable for deployment by local pathology laboratories for decentralized use.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- RT-qPCR
- breast cancer
- gene expression
- prognostic biomarker
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- art (ämneskategori)
- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Loughman, Tony
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Barron, Stephen
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Wang, Chan-Ju An ...
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Dynoodt, Peter
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Fender, Bozena
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Lopez-Ruiz, Cesa ...
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visa fler...
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Stapleton, Sharo ...
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Fabre, Aurelie
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Quinn, Cecily
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Nodin, Björn
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Jirström, Karin
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Razmara, Fatemeh
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O’Grady, Anthony
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Baird, Anne-Mari ...
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Gray, Steven G.
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Freixo, Ana
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Moelans, Cathy B ...
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van Diest, Paul ...
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Duffy, Michael J ...
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O’Leary, Desmond
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Crown, John
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Bracken, Adrian ...
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Gallagher, Willi ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
- Artiklar i publikationen
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Clinical Chemist ...
- Av lärosätet
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Lunds universitet