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Poster session 14

1238P - Detecting driver mutations by AmoyDx 11-gene PCR with high concordance with next-generation sequencing in Chinese non-small cell lung cancer patients

Date

21 Oct 2023

Session

Poster session 14

Topics

Pathology/Molecular Biology

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Dongmei Lin

Citation

Annals of Oncology (2023) 34 (suppl_2): S711-S731. 10.1016/S0923-7534(23)01942-7

Authors

D. Lin1, Y. Xi2, H. Meng3, Q. Feng1, S. Lian1, N. Gao2, J. Guo2, X. Yang4, S. Deng3, M. Li5, F. Gai5, C. Zhu5

Author affiliations

  • 1 Department Of Pathology, Chinese Academy of Medical Sciences and Peking Union Medical College - National Cancer Center, Cancer Hospital, 100021 - Beijing/CN
  • 2 Department Of Pathology, Shanxi Provincial Cancer Hospital, 030013 - Taiyuan/CN
  • 3 Department Of Pathology, Harbin Medical University Cancer Hospital, 150081 - Harbin/CN
  • 4 Department Of Pathology, Harbin Medical University Cancer Hospital, Harbin/CN
  • 5 Department Of Translational Medicine, Amoy Diagnostics Co., Ltd., 361027 - Xiamen/CN

Resources

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Abstract 1238P

Background

Identifying driver genes is crucial to make clinical decision for patients with non-small cell lung cancer (NSCLC). Except short turnaround time, higher success rate, it is still debating that PCR may cause false negative result due to its limited coverage. This study directly compared the performance of AmoyDx 11-gene PCR and NGS in the detection of known driver gene mutations in Chinese NSCLC patients.

Methods

FFPE samples from a total of 765 Chinese NSCLC patients were collected. The test performance of AmoyDx 11-gene PCR (EGFR, KRAS, ALK, HER2, ROS1, MET, BRAF, NTRK1/ 2/3, and RET) and NGS were compared.

Results

The overall percent agreement (OPA), positive percent agreement (PPA), and negative percent agreement (NPA) between AmoyDx 11-gene PCR and NGS were 98.8%, 99.3%, and 97.1%, respectively (Table). The PPA between the two assays were the same (100.0%) in common drivers (EGFR/KRAS/ALK) and rare drivers, the OPA and NPA were higher in rare drivers (99.5% vs. 99.9% and 98.8% vs. 99.8%) in AmoyDx 11-gene PCR. For rare drivers, concordance between PCR and NGS were shown in HER2 (OPA: 99.7%, PPA: 95.1% and NPA: 100.0%), ROS1 (OPA: 99.9%, PPA: 100.0% and NPA: 99.9%), MET (OPA:99.9%, PPA:96.4% and NPA:100.0%), BRAF and RET (OPA: 100.0%, PPA: 100.0% and NPA: 100.0%), respectively. Most of interestingly, for EGFR exon 20 insertion (EGFR ex20ins), a good concordance rate of 99.6% (PPA: 100.0% and NPA: 99.6%) was achieved. Table: 1238P

Comparison of AmoyDx 11-gene PCR and NGS for detecting known driver genes in NSCLC patients

NGS (mutant) NGS (wild) OPA PPA NPA
Total drivers PCR (mutant) 591 5 98.8% 99.3% 97.1%
PCR (wild) 4 165
Common drivers PCR (mutant) 425 4 99.5% 100.0% 98.8%
PCR (wild) 0 336
Rare drivers PCR (mutant) 156 1 99.9% 100.0% 99.8%
PCR (wild) 0 608
EGFR exon20ins PCR (mutant) 24 3 99.6% 100.0% 99.6%
PCR (wild) 0 738
HER2 PCR (mutant) 39 0 99.7% 95.1% 100.0%
PCR (wild) 2 724
ROS1 PCR (mutant) 19 1 99.9% 100.0% 99.9%
PCR (wild) 0 745
BRAF PCR (mutant) 19 0 100.0% 100.0% 100.0%
PCR (wild) 0 746
RET PCR (mutant) 25 0 100.0% 100.0% 100.0%
PCR (wild) 0 740
MET PCR (mutant) 27 0 99.9% 96.4% 100.0%
PCR (wild) 1 737

Conclusions

AmoyDx 11-gene PCR displayed high concordance to NGS in detecting driver mutations of NSCLC, especially rare drivers (EGFR ex20ins), suggesting it is an excellent choice in clinical practice.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

M. Li, F. Gai, C. Zhu: Financial Interests, Personal, Full or part-time Employment: Amoy Diagnostics. All other authors have declared no conflicts of interest.

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