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Analytical validation of OncoMasTR, a multigene test for predicting risk of distant recurrence in hormone receptor-positive early stage breast cancer

Loughman, T. ; Chan-Ju Wang, A. ; Dynoodt, P. ; Fender, B. ; Lopez Ruiz, C. ; Barron, S. ; Stapleton, S. ; O'Leary, D. ; Fabre, A. and Quinn, C. , et al. (2018) In Annals of oncology : official journal of the European Society for Medical Oncology 29(Suppl. 8). p.65-65
Abstract
Background: OncoMasTR is a new multigene prognostic test that was discovered via a novel transcriptional network analysis method that identified upstream Master Transcription Regulators (MTRs), which regulate previously identified prognostic biomarkers. The optimised OncoMasTR signature incorporating clinicopathological information has been shown to be significantly prognostic for predicting distant recurrence in two independent cohorts (TransATAC & a subset of TAILORx from participating Irish centres). The analytical performance characteristics of the OncoMasTR test, comprising solely three prognostic MTRs, were determined.

Methods: Relative gene expression levels were measured by RT-qPCR. Assay precision and input ranges... (More)
Background: OncoMasTR is a new multigene prognostic test that was discovered via a novel transcriptional network analysis method that identified upstream Master Transcription Regulators (MTRs), which regulate previously identified prognostic biomarkers. The optimised OncoMasTR signature incorporating clinicopathological information has been shown to be significantly prognostic for predicting distant recurrence in two independent cohorts (TransATAC & a subset of TAILORx from participating Irish centres). The analytical performance characteristics of the OncoMasTR test, comprising solely three prognostic MTRs, were determined.

Methods: Relative gene expression levels were measured by RT-qPCR. Assay precision and input ranges were determined using a panel of samples representative of low and high recurrence risk tested across a number of runs incorporating different sources of variation. Serial dilutions of a pooled patient RNA sample was used to establish the linear range and efficiency of the individual gene assays.

Results: The overall standard deviation of the OncoMasTR risk score was 0.15, which represents less than 2% of the 10-unit risk score range. The majority of the variability in OncoMasTR results was related to within-run variation (78.2%) with other between-run variation sources contributing relatively little (PCR instrument (0.6%), assay operator (5.2%), reagent lots (7.3%) or loading position (8.7%)). Consistent risk scores were measured for individual samples from 40ng down to < 1ng RNA per PCR reaction. Individual gene assays were linear over >500-fold RNA input range corresponding to CT values of 23 – 36, demonstrating the ability of the test to reliably detect low level expression of the OncoMasTR panel. Importantly, PCR efficiencies were similar for the individual MTR and reference gene assays which ranged from 79 – 95%.

Conclusions: The OncoMasTR prognostic test displays robust analytical and clinical performance and is being launched as a CE-marked test. The concise nature of the three gene signature and a simplified workflow that can be readily adopted using standard laboratory equipment will enable convenient qualification by local laboratories for decentralised use. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Annals of oncology : official journal of the European Society for Medical Oncology
volume
29
issue
Suppl. 8
pages
65 - 65
publisher
Oxford University Press
external identifiers
  • pmid:32137767
ISSN
1569-8041
DOI
10.1093/annonc/mdy270.199
language
English
LU publication?
yes
id
688e707a-b20b-4cec-b835-9ba3fb0f40a7
date added to LUP
2020-03-31 13:41:35
date last changed
2024-01-29 02:54:54
@misc{688e707a-b20b-4cec-b835-9ba3fb0f40a7,
  abstract     = {{Background: OncoMasTR is a new multigene prognostic test that was discovered via a novel transcriptional network analysis method that identified upstream Master Transcription Regulators (MTRs), which regulate previously identified prognostic biomarkers. The optimised OncoMasTR signature incorporating clinicopathological information has been shown to be significantly prognostic for predicting distant recurrence in two independent cohorts (TransATAC &amp; a subset of TAILORx from participating Irish centres). The analytical performance characteristics of the OncoMasTR test, comprising solely three prognostic MTRs, were determined.<br>
<br>
Methods: Relative gene expression levels were measured by RT-qPCR. Assay precision and input ranges were determined using a panel of samples representative of low and high recurrence risk tested across a number of runs incorporating different sources of variation. Serial dilutions of a pooled patient RNA sample was used to establish the linear range and efficiency of the individual gene assays.<br>
<br>
Results: The overall standard deviation of the OncoMasTR risk score was 0.15, which represents less than 2% of the 10-unit risk score range. The majority of the variability in OncoMasTR results was related to within-run variation (78.2%) with other between-run variation sources contributing relatively little (PCR instrument (0.6%), assay operator (5.2%), reagent lots (7.3%) or loading position (8.7%)). Consistent risk scores were measured for individual samples from 40ng down to &lt; 1ng RNA per PCR reaction. Individual gene assays were linear over &gt;500-fold RNA input range corresponding to CT values of 23 – 36, demonstrating the ability of the test to reliably detect low level expression of the OncoMasTR panel. Importantly, PCR efficiencies were similar for the individual MTR and reference gene assays which ranged from 79 – 95%.<br>
<br>
Conclusions: The OncoMasTR prognostic test displays robust analytical and clinical performance and is being launched as a CE-marked test. The concise nature of the three gene signature and a simplified workflow that can be readily adopted using standard laboratory equipment will enable convenient qualification by local laboratories for decentralised use.}},
  author       = {{Loughman, T. and Chan-Ju Wang, A. and Dynoodt, P. and Fender, B. and Lopez Ruiz, C. and Barron, S. and Stapleton, S. and O'Leary, D. and Fabre, A. and Quinn, C. and Nodin, B. and Jirstrom, K. and Bracken, A. and Gallagher, W. M.}},
  issn         = {{1569-8041}},
  language     = {{eng}},
  note         = {{Conference Abstract}},
  number       = {{Suppl. 8}},
  pages        = {{65--65}},
  publisher    = {{Oxford University Press}},
  series       = {{Annals of oncology : official journal of the European Society for Medical Oncology}},
  title        = {{Analytical validation of OncoMasTR, a multigene test for predicting risk of distant recurrence in hormone receptor-positive early stage breast cancer}},
  url          = {{http://dx.doi.org/10.1093/annonc/mdy270.199}},
  doi          = {{10.1093/annonc/mdy270.199}},
  volume       = {{29}},
  year         = {{2018}},
}