作者
M Marín-Aguilera, P Jares, E Sanfeliu, G Villacampa, E Hernández-Lllán, AI Martínez-Puchol, S Shankar, B González-Farré, AG Waks, F Brasó-Maristany, F Pardo, DK Manning, JA Abery, J Curaba, L Moon, O Gordon, P Galván, P Wachirakantapong, O Castillo, CM Nee, P Blasco, TH Senevirathne, V Sirenko, O Martínez-Sáez, A Aguirre, IE Krop, Z Li, P Spellman, O Metzger Filho, K Polyak, P Michaels, JA Puig-Butillé, A Vivancos, J Matito, W Buckingham, CM Perou, P Villagrasa-González, A Prat, JS Parker, L Paré
发表日期
2024/3/1
期刊
ESMO open
卷号
9
期号
3
页码范围
102903
出版商
Elsevier
简介
Background
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.
Materials and methods
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 …
学术搜索中的文章
M Marín-Aguilera, P Jares, E Sanfeliu, G Villacampa… - ESMO open, 2024