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Cited by 311

The DOI matches its Crossref record; 36 of the 36 references it cites were found in a registry or an index.

Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens

Open access
Nielsen, Torsten, Wallden, Brett, Schaper, Carl, Ferree, Sean, Liu, Shuzhen, Gao, Dongxia, Barry, Garrett, Dowidar, Naeem, Maysuria, Malini, Storhoff, James·2014·BMC Cancer
DOI 10.1186/1471-2407-14-177
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Abstract

BACKGROUND: NanoString's Prosigna™ Breast Cancer Prognostic Gene Signature Assay is based on the PAM50 gene expression signature. The test outputs a risk of recurrence (ROR) score, risk category, and intrinsic subtype (Luminal A/B, HER2-enriched, Basal-like). The studies described here were designed to validate the analytical performance of the test on the nCounter Analysis System across multiple laboratories. METHODS: Analytical precision was measured by testing five breast tumor RNA samples across 3 sites. Reproducibility was measured by testing replicate tissue sections from 43 FFPE breast tumor blocks across 3 sites following independent pathology review at each site. The RNA input range was validated by comparing assay results at the extremes of the specified range to the nominal RNA input level. Interference was evaluated by including non-tumor tissue into the test. RESULTS: The measured standard deviation (SD) was less than 1 ROR unit within the analytical precision study and the measured total SD was 2.9 ROR units within the reproducibility study. The ROR scores for RNA inputs at the extremes of the range were the same as those at the nominal input level. Assay results were stable in the presence of moderate amounts of surrounding non-tumor tissue (<70% by area). CONCLUSIONS: The analytical performance of NanoString's Prosigna assay has been validated using FFPE breast tumor specimens across multiple clinical testing laboratories.

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Metadata

Authors
Nielsen, T., Wallden, B., Schaper, C., Ferree, S., Liu, S., Gao, D., Barry, G., Dowidar, N., Maysuria, M., & Storhoff, J.
Venue
BMC Cancer
Publisher
Springer Science and Business Media LLC
Published
2014-03-13
Volume
14
Issue
1
Pages
177-177
ISSN
1471-2407 (ISSN-L)
DOI
10.1186/1471-2407-14-177
OpenAlex
W1976022788
Cited by
311
References
36
FWCI
11.95
Type
journal article
Language
en
Open access
gold

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CoChat. (2026). Citation check: Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens. https://app.cochat.ai/papers/10.1186/1471-2407-14-177
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Nielsen, T., Wallden, B., Schaper, C., Ferree, S., Liu, S., Gao, D., Barry, G., Dowidar, N., Maysuria, M., & Storhoff, J. (2014). Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens. BMC Cancer. https://doi.org/10.1186/1471-2407-14-177

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