PMID- 36052254
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220907
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 12
DP  - 2022
TI  - Lentiviral vector-based xenograft tumors as candidate reference materials for 
      detection of HER2-low breast cancer.
PG  - 955943
LID - 10.3389/fonc.2022.955943 [doi]
LID - 955943
AB  - The human epidermal growth factor receptor 2 (HER2) is an important biomarker 
      that plays a pivotal role in therapeutic decision-making for patients with breast 
      cancer (BC). Patients with HER2-low BC can benefit from new HER2 targeted 
      therapy. For ensuring the accurate and reproducible detection of HER2-low cancer, 
      reliable reference materials are required for monitoring the sensitivity and 
      specificity of detection assays. Herein, a lentiviral vector was used to 
      transduce the HER2 gene into MDA-MB-231 cells that exhibited low HER2 density, 
      and the cells were characterized by droplet digital PCR to accurately determine 
      the copy number variation. Then, the formalin-fixed paraffin-embedded (FFPE) 
      samples from xenografts were prepared and evaluated for suitability as candidate 
      reference materials by immunohistochemistry (IHC) and fluorescence in situ 
      hybridization (FISH). The FFPE reference materials were selected on the basis of 
      IHC score of 2+ and negative FISH result to meet the requirement for HER2-low BC 
      detection. Furthermore, the FFPE reference materials exhibited typical 
      histological structures that resembled the clinical BC specimens. These novel 
      FFPE reference materials displayed the high stability and homogeneity, and they 
      were produced in high quantity. In summary, we generated high-quality reference 
      materials for internal quality control and proficiency testing in HER2-low 
      detection.
CI  - Copyright (c) 2022 Wei, An, Cao, Che, Xue, Deng, Wang and Zhou.
FAU - Wei, Yali
AU  - Wei Y
AD  - Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical 
      Medical College of Capital Medical University, Beijing, China.
FAU - An, Xu
AU  - An X
AD  - Department of Clinical Laboratory, Tongzhou Maternal and Child Health Hospital of 
      Beijing, Beijing, China.
FAU - Cao, Qinmei
AU  - Cao Q
AD  - Department of Clinical Laboratory, China-Japan Friendship Hospital, Clinical 
      Medical College of Capital Medical University, Beijing, China.
FAU - Che, Nanying
AU  - Che N
AD  - Department of Pathology, Beijing Chest Hospital, Capital Medical University, 
      Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.
FAU - Xue, Yuanyuan
AU  - Xue Y
AD  - Ministry of Education (MOE) Key Laboratory of Bioinformatics, Center for 
      Synthetic and Systematic Biology, School of Life Sciences, Tsinghua University, 
      Beijing, China.
FAU - Deng, Haiteng
AU  - Deng H
AD  - Ministry of Education (MOE) Key Laboratory of Bioinformatics, Center for 
      Synthetic and Systematic Biology, School of Life Sciences, Tsinghua University, 
      Beijing, China.
FAU - Wang, Qingtao
AU  - Wang Q
AD  - Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical 
      Medical College of Capital Medical University, Beijing, China.
FAU - Zhou, Rui
AU  - Zhou R
AD  - Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical 
      Medical College of Capital Medical University, Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20220816
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC9425432
OTO - NOTNLM
OT  - HER2-low
OT  - digital PCR
OT  - lentiviral vector
OT  - quality assurance
OT  - reference materials
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/09/03 06:00
MHDA- 2022/09/03 06:01
PMCR- 2022/01/01
CRDT- 2022/09/02 02:48
PHST- 2022/05/29 00:00 [received]
PHST- 2022/07/14 00:00 [accepted]
PHST- 2022/09/02 02:48 [entrez]
PHST- 2022/09/03 06:00 [pubmed]
PHST- 2022/09/03 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2022.955943 [doi]
PST - epublish
SO  - Front Oncol. 2022 Aug 16;12:955943. doi: 10.3389/fonc.2022.955943. eCollection 
      2022.