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The AmoyDx® Pan Lung Cancer PCR Panel (PLC Panel) is a tissue-based, real-time, qPCR assay for in vitro diagnostics (IVD). The PLC Panel enables qualitative detection of up to 167 variants (85 DNA mutations and 82 RNA fusions) in 11 genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3), identifying all NCCN recommended biomarkers in a single PCR run. The PLC Panel is intended to assist in identifying clinically relevant biomarkers for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies at minimal cost. The kit is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.




Clinical Performance
 



The clinical performance of PLC Panel was validated in a concordance study by LC-SCRUM-Japan.1 Results were highly concordant with the reference NGS assay for alterations (fusion, indels, SNVs) across 11 actionable biomarkers.







1. Matsumoto, S., et. al. Prospective concordance study of a multi-gene PCR assay and NGS for the detection of targetable gene alterations in lung cancer [abstract] in Journal of Thoracic Oncology. 2021 March; 16:3(S690): WCLC; 2020. Abstract P89.06.

Mutations( Hover over each mutational type to highlight genes covered )

All
FUSIONS
INDELS
SNV
SNV/INDELS
EGFR

EGFR

SNV/INDELS
HER2

HER2

INDELS
KRAS

KRAS

SNV
BRAF

BRAF

SNV
ALK

ALK

FUSIONS
RET

RET

FUSIONS
ROS1

ROS1

FUSIONS
NTRK1

NTRK1

FUSIONS
NTRK2

NTRK2

FUSIONS
NTRK3

NTRK3

FUSIONS
MET

MET

FUSIONS

Fast turnround time within 1 day

Fast turnround time within
1 day

Target 167 variants (85 DNA mutations and 82 RNA fusions) in 11 biomarkers

Target 167 variants (85 DNA mutations and 82 RNA fusions) in 11 biomarkers

Cost-effective

Cost-effective

Higher detection rate and higher success rate

Higher detection rate and higher success rate

Specifications

Tests/kit
8
Instrument
QuantStudio™ 5, LightCycler® 480 II, cobas z 480, Bio-Rad CFX96, SLAN-96S
Sample requirement
FFPE or fresh/frozen tissue minimum 60 ng DNA; minimum 120 ng RNA

Publications

1. Hirotsu, Y., Nakagomi, T., Nagakubo, Y. et al. Simulation analysis of EGFR mutation detection: Oncomine Dx target test and AmoyDx panel impact on lung cancer treatment decisions. Sci Rep 14, 1594 (2024).

2. Takeyasu Y, Yoshida T, Masuda K, et al. Distinct progression and efficacy of first-line osimertinib treatment according to mutation subtypes in metastatic NSCLC harboring EGFR mutations. JTO Clin Res Rep. 2024;5:100636.

3. Sakamoto T, Matsubara T, Takahama T, et al. Biomarker Testing in Patients With Unresectable Advanced or Recurrent Non–Small Cell Lung Cancer. JAMA Netw Open. 2023;6(12):e2347700.

4. Ishioka Y, Tanaka H, Makiguchi T, Fujishima S, Nunomura Y, Sakamoto H, Shiratori T, Taima K and Tasaka S: Predictors of efficacy of anamorelin in patients with non‑small cell lung cancer and cachexia: A retrospective study. Oncol Lett 27: 22, 2024

5. Okimura A, Hirano H, Ito Y, et al. (September 11, 2023) Primary Lung Adenocarcinoma With ALK Gene Rearrangement Mostly Occupied by the Signet-Ring Cell Carcinoma Component: A Case Report. Cureus 15(9): e45068.

6. Pecciarini L, Brunetto E, Grassini G, De Pascali V, Ogliari FR, Talarico A, Marra G, Magliacane G, Redegalli M, Arrigoni G, et al. Gene Fusion Detection in NSCLC Routine Clinical Practice: Targeted-NGS or FISH? Cells. 2023; 12(8):1135.

7. Gu Y, Zhang S, Liang X, Zhao H, Li X, Lu J. Clinical and Pathological Characteristics and Prognosis of Lung Adenocarcinoma With High-Grade Fetal Features: A Retrospective Analysis. International Journal of Surgical Pathology. 2023;0(0).

8. Wang, Lei-Chi et al. Panoramic Tissue Examination That Integrates 3-Dimensional Pathology Imaging and Gene Mutation: Potential Utility in Non–Small Cell Lung Cancer. Laboratory Investigation, Volume 103, Issue 9, 100195.

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