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Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer

Marín-Aguilera, M. ; Jares, P. ; Sanfeliu, E. ; Villacampa, G. ; Hernández-lllán, E. ; Martínez-Puchol, A.I. ; Shankar, S. ; González-Farré, B. ; Waks, A.G. ; Brasó-Maristany, F. ; Pardo, F. ; Manning, D.K. ; Abery, J.A. ; Curaba, J. ; Moon, L. ; Gordon, O. ; Galván, P. ; Wachirakantapong, P. ; Castillo, O. ; Nee, C.M. ; Blasco, P. ; Senevirathne, T.H. ; Sirenko, V. ; Martínez-Sáez, O. ; Aguirre, A. ; Krop, I.E. ; Li, Z. ; Spellman, P. ; Metzger Filho, O. ; Polyak, K. ; Michaels, P. ; Puig-Butillé, J.A. ; Vivancos, A. ; Matito, J. ; Buckingham, W. ; Perou, C.M. ; Villagrasa-González, P. ; Prat, A. ; Parker, J.S. ; Paré, L.

ESMO open, 2024-03, Vol.9 (3), p.102903-102903, Article 102903 [Revista revisada por pares]

England: Elsevier Ltd

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Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer
Autor: Marín-Aguilera, M. ; Jares, P. ; Sanfeliu, E. ; Villacampa, G. ; Hernández-lllán, E. ; Martínez-Puchol, A.I. ; Shankar, S. ; González-Farré, B. ; Waks, A.G. ; Brasó-Maristany, F. ; Pardo, F. ; Manning, D.K. ; Abery, J.A. ; Curaba, J. ; Moon, L. ; Gordon, O. ; Galván, P. ; Wachirakantapong, P. ; Castillo, O. ; Nee, C.M. ; Blasco, P. ; Senevirathne, T.H. ; Sirenko, V. ; Martínez-Sáez, O. ; Aguirre, A. ; Krop, I.E. ; Li, Z. ; Spellman, P. ; Metzger Filho, O. ; Polyak, K. ; Michaels, P. ; Puig-Butillé, J.A. ; Vivancos, A. ; Matito, J. ; Buckingham, W. ; Perou, C.M. ; Villagrasa-González, P. ; Prat, A. ; Parker, J.S. ; Paré, L.
Materias: analytical validation ; breast cancer ; Breast Neoplasms - genetics ; Breast Neoplasms - pathology ; Female ; gene expression ; HER2DX ; Humans ; Neoplasm Recurrence, Local - genetics ; Original Research ; Reproducibility of Results ; RNA ; RNA - analysis ; RNA, Messenger - genetics
Es parte de: ESMO open, 2024-03, Vol.9 (3), p.102903-102903, Article 102903
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
These authors contributed equally.
Descripción: HER2DX, a multianalyte genomic test, has been clinically validated to predict breast cancer recurrence risk (relapse risk score), the probability of achieving pathological complete response post-neoadjuvant therapy (pCR likelihood score), and individual ERBB2 messenger RNA (mRNA) expression levels in patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This study delves into the comprehensive analysis of HER2DX’s analytical performance. Precision and reproducibility of HER2DX risk, pCR, and ERBB2 mRNA scores were assessed within and between laboratories using formalin-fixed paraffin-embedded (FFPE) tumor tissues and purified RNA. Robustness was appraised by analyzing the impact of tumor cell content and protocol variations including different instruments, reagent lots, and different RNA extraction kits. Variability was evaluated across intratumor biopsies and genomic platforms [RNA sequencing (RNAseq) versus nCounter], and according to protocol variations. Precision analysis of 10 FFPE tumor samples yielded a maximal standard error of 0.94 across HER2DX scores (1-99 scale). High reproducibility of HER2DX scores across 29 FFPE tumors and 20 RNAs between laboratories was evident (correlation coefficients >0.98). The probability of identifying score differences >5 units was ≤5.2%. No significant variability emerged based on platform instruments, reagent lots, RNA extraction kits, or TagSet thaw/freeze cycles. Moreover, HER2DX displayed robustness at low tumor cell content (10%). Intratumor variability across 212 biopsies (106 tumors) was <4.0%. Concordance between HER2DX scores from 30 RNAs on RNAseq and nCounter platforms exceeded 90.0% (Cohen’s κ coefficients >0.80). The HER2DX assay is highly reproducible and robust for the quantification of recurrence risk, pCR likelihood, and ERBB2 mRNA expression in early-stage HER2-positive breast cancer. •HER2DX assay is highly reproducible and robust intra- and inter-laboratories.•HER2DX proved robust performance for different protocol variations including different platforms.•HER2DX has proven technical reliability in predicting outcomes for early-stage HER2-positive breast cancer.
Editor: England: Elsevier Ltd
Idioma: Inglés

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Analytical validation of HER2DX genomic test for early-stage HER2-positive breast cancer

England: Elsevier Ltd

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