PMID- 32543087
OWN - NLM
STAT- MEDLINE
DCOM- 20210812
LR  - 20220119
IS  - 1759-7714 (Electronic)
IS  - 1759-7706 (Print)
IS  - 1759-7706 (Linking)
VI  - 11
IP  - 8
DP  - 2020 Aug
TI  - Clinical evaluation of the effectiveness of fusion-induced asymmetric 
      transcription assay-based reverse transcription droplet digital PCR for ALK 
      detection in formalin-fixed paraffin-embedded samples from lung cancer.
PG  - 2252-2261
LID - 10.1111/1759-7714.13535 [doi]
AB  - BACKGROUND: Accurate detection of anaplastic lymphoma kinase (ALK) rearrangement 
      is the prerequisite for anti-ALK therapy for the patient with non-small cell lung 
      cancer (NSCLC). Fusion-induced asymmetric transcription assay (FIATA)-based 
      reverse transcription droplet digital PCR (RT-ddPCR) was developed and performed 
      for ALK status survey in NSCLC samples. METHODS: A total of 269 cases of 
      formalin-fixed paraffin-embedded (FFPE) specimens from NSCLC, in which ALK status 
      was confirmed by both fluorescence in situ hybridization (FISH) and 
      immunohistochemistry (IHC), were analyzed by FIATA-based RT-ddPCR. RESULTS: In 
      the ALK-positive group, the 3' ALK transcript copies range was 336.6-107 955.4, 
      and the R3 [(the ratio of the 3' ALK transcript copy numbers to the internal 
      reference gene transcript copy numbers) x 100] was 17.23-672.77. In the 
      ALK-negative group, the 3' ALK transcript copies range was 3.7-1370.6, and the R3 
      range was 0.10-15.57. The lowest R3 level in the ALK-positive group was 
      significantly higher than the highest R3 level in the ALK-negative group. A 
      positive correlation between the proportion of cancer cells in the tissue section 
      and ALK RNA expression level (R3) was found (P < 0.05). There was no relationship 
      between the percentage of FISH positive cells or FISH positive signal patterns 
      and R3 level of the ALK gene. Compared with FISH and IHC, the clinical 
      sensitivity and specificity of FIATA-based RT-ddPCR for ALK detection were 100%, 
      respectively. CONCLUSIONS: An absolute quantitative FIATA-based RT-ddPCR was 
      developed and validated for ALK fusion detection in NSCLC. This method can 
      rapidly, accurately, and objectively classify ALK types and help with individual 
      therapy.
CI  - (c) 2020 The Authors. Thoracic Cancer published by China Lung Oncology Group and 
      John Wiley & Sons Australia, Ltd.
FAU - Liu, Yuanyuan
AU  - Liu Y
AD  - Department of Pathology, Peking Union Medical College Hospital, Molecular 
      Pathology Research Center, Chinese Academy of Medical Sciences, Beijing, China.
FAU - Wu, Shafei
AU  - Wu S
AD  - Department of Pathology, Peking Union Medical College Hospital, Molecular 
      Pathology Research Center, Chinese Academy of Medical Sciences, Beijing, China.
FAU - Shi, Xiaohua
AU  - Shi X
AD  - Department of Pathology, Peking Union Medical College Hospital, Molecular 
      Pathology Research Center, Chinese Academy of Medical Sciences, Beijing, China.
FAU - Lu, Linping
AU  - Lu L
AD  - TargetingOne Corporation, Beijing, China.
FAU - Zhu, Lingxiang
AU  - Zhu L
AD  - National Research Institute for Family Planning, Beijing, China.
FAU - Guo, Yong
AU  - Guo Y
AD  - Department of Biomedical Engineering, School of Medicine, Tsinghua University, 
      Beijing, China.
FAU - Zhang, Li
AU  - Zhang L
AD  - Department of Respiratory Diseases, Peking Union Medical College Hospital, 
      Chinese Academy of Medical Sciences, Beijing, China.
FAU - Zeng, Xuan
AU  - Zeng X
AUID- ORCID: 0000-0002-8711-753X
AD  - Department of Pathology, Peking Union Medical College Hospital, Molecular 
      Pathology Research Center, Chinese Academy of Medical Sciences, Beijing, China.
LA  - eng
GR  - 2017-I2M-1-005/Chinese Academy of Medical Sciences (CAMS) Initiative for 
      Innovative Medicine/International
GR  - 2017YFC1309004/National Key Research and Development Program of 
      China/International
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200616
PL  - Singapore
TA  - Thorac Cancer
JT  - Thoracic cancer
JID - 101531441
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
SB  - IM
CIN - Thorac Cancer. 2022 Jan;13(1):146. PMID: 34799988
MH  - Anaplastic Lymphoma Kinase/*genetics
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*diagnostic imaging/pathology
MH  - Male
MH  - Paraffin Embedding/*methods
MH  - Polymerase Chain Reaction/*methods
PMC - PMC7396369
OTO - NOTNLM
OT  - ALK
OT  - asymmetric
OT  - droplet digital PCR
OT  - lung cancer
OT  - rearrangement
EDAT- 2020/06/17 06:00
MHDA- 2021/08/13 06:00
PMCR- 2020/08/01
CRDT- 2020/06/17 06:00
PHST- 2020/04/07 00:00 [received]
PHST- 2020/05/25 00:00 [revised]
PHST- 2020/05/26 00:00 [accepted]
PHST- 2020/06/17 06:00 [pubmed]
PHST- 2021/08/13 06:00 [medline]
PHST- 2020/06/17 06:00 [entrez]
PHST- 2020/08/01 00:00 [pmc-release]
AID - TCA13535 [pii]
AID - 10.1111/1759-7714.13535 [doi]
PST - ppublish
SO  - Thorac Cancer. 2020 Aug;11(8):2252-2261. doi: 10.1111/1759-7714.13535. Epub 2020 
      Jun 16.