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TEST:
AmoyDx® Pan Lung Cancer PCR Panel

Type:
Other Approval
Related tests:
21d
Lung adenocarcinoma with ALK deletion of exons 6-20 with response to sequential ALK inhibitors: a case report. (PubMed, Transl Lung Cancer Res)
Herein, we report a case of lung adenocarcinoma harboring ALK deletions of exons 6-20 that responded to alectinib and lorlatinib treatment...Despite the high expression of programmed death ligand 1 (PD-L1) (tumor proportion score: 95%), the response to pembrolizumab and chemotherapy was limited...This case suggests that ALK internal deletions, even those affecting exon 20, demonstrate oncogenic potential and sensitivity to ALK inhibitors. ALK IHC remains an essential complementary test in cases of high clinical suspicion and inconclusive results using initial molecular testing.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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PD-L1 expression • ALK rearrangement
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FoundationOne® CDx • AmoyDx® Pan Lung Cancer PCR Panel
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Keytruda (pembrolizumab) • Alecensa (alectinib) • Lorbrena (lorlatinib)
2ms
Implementation of Real-World Diagnostic Strategies in Taiwan for the Identification of Targetable Oncogenic Driver Alterations in Non-Small Cell Lung Cancer. (PubMed, JCO Glob Oncol)
This study highlighted the effectiveness of multigene PCR testing in identifying actionable NSCLC biomarkers for low failure rate, short TAT, and minimal tissue requirements, enabling timely, personalized interventions. The workflow implemented at Chi Mei Medical Center provides a model that other hospitals can adopt to overcome testing barriers and improve precision oncology access.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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KRAS G12C • KRAS G12 • EGFR negative
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AmoyDx® Pan Lung Cancer PCR Panel
5ms
First-Line Osimertinib for EGFR-Mutated Squamous Cell Lung Carcinoma: A Case Report. (PubMed, Cancer Rep (Hoboken))
We encountered a rare EGFR-mutated squamous cell lung carcinoma that responded well to osimertinib. Osimertinib may be an option for the treatment of patients with EGFR-mutated squamous cell lung carcinoma.
Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
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EGFR mutation • EGFR L858R
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AmoyDx® Pan Lung Cancer PCR Panel
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Tagrisso (osimertinib)
7ms
A Prompt Diagnosis of Ascites and Dramatic Effect of Alectinib for Advanced Lung Adenocarcinoma Harboring EML4-ALK Fusion: A Case Report. (PubMed, Intern Med)
The tumor size had decreased significantly, and the patient was discharged on day 34. This case highlights the necessity of multiplex genetic testing even when ALK immunostaining is negative.
Journal
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EML4 (EMAP Like 4)
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ALK fusion
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AmoyDx® Pan Lung Cancer PCR Panel
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Alecensa (alectinib)
9ms
Press Release Biocartis NV: Biocartis Announces Multiple Abstracts Demonstrating the Impact of Idylla in Oncology Diagnostics to be Presented at USCAP 2025 Annual Meeting (GlobeNewswire)
"Seven abstracts from leading research and academic institutions will be presented as posters, highlighting the rapid, fully automated molecular testing capabilities of the Idylla Platform across several different cancer types, including lung cancer, thyroid cancer, endometrial carcinoma and colorectal cancer. Biocartis also continues to focus on melanoma, blood, brain and breast cancer."
Clinical data
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AmoyDx® Pan Lung Cancer PCR Panel • Idylla™ GeneFusion Assay • Idylla™ BRAF Mutation Test • Idylla™ EGFR Mutation Test • Idylla™ KRAS Mutation Test • Idylla™ MSI Test
1year
ROS1-Rearranged Lung Cancer With Extensive Calcification on Computed Tomography: A Case Report. (PubMed)
A bronchoscopy with transbronchial lung biopsy of the right S5 nodule confirmed the diagnosis of adenocarcinoma. The biopsy specimen was analyzed using the AmoyDx® Pan Lung Cancer PCR Panel, which detected ROS1 fusions.
Journal
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AmoyDx® Pan Lung Cancer PCR Panel
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Xalkori (crizotinib)
1year
AmoyDx® Pan Lung Cancer PCR Panel approved in Japan as a companion diagnostic for AUGTYRO® (repotrectinib) (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd...and Precision Medicine Asia Co., Ltd...announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel...as a companion diagnostic (CDx) for AUGTYRO® (repotrectinib) for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with ROS1 fusion gene."
Japan approval
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AmoyDx® Pan Lung Cancer PCR Panel
1year
AmoyDx® Pan Lung Cancer PCR Panel receives China NMPA Approval (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...recently announced that the China National Medical Products Administration (NMPA) has approved its AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') for use in identifying EGFR, ALK, ROS1, and METex14 skipping mutations in non-small cell lung cancer (NSCLC) patients."
China approval
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AmoyDx® Pan Lung Cancer PCR Panel
1year
Genomic profiling for perioperative targeted therapy in patients with early-stage non-small cell lung cancer: LC-SCRUM-advantage/MRD (ESMO Asia 2024)
Conclusions The frequency of AGAs in early-stage NSCLC was similar to that previously being reported for advanced NSCLC. Genomic screening for early-stage NSCLC could help to detect AGAs particularly in non-Sq NSCLC.
Clinical
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • RET fusion • ALK fusion • MET mutation • KRAS G12 • NTRK fusion
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AmoyDx® Pan Lung Cancer PCR Panel • Oncomine Precision Assay
over1year
AmoyDx® Pan Lung Cancer PCR Panel approved in Japan as a companion diagnostic for Haiyitan® tablets (gumarontinib) (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd...and Precision Medicine Asia Co., Ltd...announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') as a companion diagnostic for Haiyitan® (gumarontinib), a product of Haihe Biopharma K.K. Haiyitan® in 50 mg tablet form, was approved by MHLW in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations."
Japan approval
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AmoyDx® Pan Lung Cancer PCR Panel
over1year
Suitability of frozen cell pellets from cytology specimens for the Amoy 9-in-1 assay in patients with non-small cell lung cancer. (PubMed, Thorac Cancer)
FCPs can be successfully used in the AmoyDx PLC panel, with higher success rate compared with the NGS assay. The AmoyDx PLC panel may be an option in cases when insufficient tissue sample is available for the NGS assay.
Journal • Cytology
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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AmoyDx® Pan Lung Cancer PCR Panel
over1year
Comparison of diagnostic performance between Oncomine Dx target test and AmoyDx panel for detecting actionable mutations in lung cancer. (PubMed)
The ODxTT missed two uncovered EGFR rare variants, which was visually confirmed in the raw sequencing data. Our study provides insights into real-world performance of CDx tests for lung cancer and ensures reliability to advance precision medicine.
Journal • Clinical
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Oncomine™ Dx Target Test • AmoyDx® Pan Lung Cancer PCR Panel