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TEST:
AmoyDx® Pan Lung Cancer PCR Panel

Type:
Other Approval
Related tests:
2ms
Feasibility of detecting NSCLC-associated fusion genes in long-term preserved FFPE samples (ELCC 2024)
The overall concordance rate was 93.3%, with concordance rates for each group are 97.7% (2-3 years), 100% (4 years), and 80.0% (≥ 5 years), respectively. Conclusions PCR effectively detects mRNA in long-term preserved FFPE samples, providing valuable variant information for treatment guidance in NSCLC patients, even after extended storage periods.
ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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ALK positive • RET fusion • MET exon 14 mutation • ALK fusion • RET mutation • ROS1 fusion • MET mutation
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AmoyDx® Pan Lung Cancer PCR Panel
2ms
Simulation analysis of EGFR mutation detection: Oncomine Dx target test and AmoyDx panel impact on lung cancer treatment decisions. (PubMed, Sci Rep)
These findings suggest that while both CDx tests are effective in detecting almost all actionable EGFR mutations, ODxTT provides slightly broader coverage. These results emphasize the importance of selecting appropriate CDx tests to inform treatment decisions for EGFR-positive NSCLC patients.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR positive • EGFR exon 18 mutation
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Oncomine™ Dx Target Test • AmoyDx® Pan Lung Cancer PCR Panel
6ms
Clinical validation of a multiplex polymerase chain reaction (mPCR) assay to identify patients (pts) with NSCLC suitable for mobocertinib treatment (ESMO Asia 2023)
In the retrospective analysis, mPCR identified EGFR ex20ins in an estimated 79.0% (502/636) of pts. Conclusions The AmoyDx mPCR assay performed better than traditional PCR and effectively identified pts with EGFR ex20ins+ NSCLC who may benefit from mobocertinib therapy, providing a fast and effective diagnostic option to guide treatment.
Clinical • Polymerase Chain Reaction
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EGFR (Epidermal growth factor receptor)
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EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
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AmoyDx® Pan Lung Cancer PCR Panel
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Exkivity (mobocertinib)
8ms
Detecting driver mutations by AmoyDx 11-gene PCR with high concordance with next-generation sequencing in Chinese non-small cell lung cancer patients (ESMO 2023)
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 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 • Next-generation sequencing • Discordant
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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) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3)
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EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
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AmoyDx® Pan Lung Cancer PCR Panel
8ms
Genomic screening by multi-gene assay for perioperative targeted therapy in patients with early-stage non-small cell lung cancer: LC-SCRUM-Advantage/MRD (ESMO 2023)
Conclusions Multi-PCR panel showed a high success rate and a short TAT in genomic screening by preoperative biopsy tumor samples. Multi-PCR panel would help to better detect actionable oncogenic drivers in patients with early-stage 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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KRAS mutation • EGFR mutation • KRAS G12C • EGFR L858R • EGFR exon 19 deletion • KRAS G12D • RET fusion • KRAS G12
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AmoyDx® Pan Lung Cancer PCR Panel • Oncomine Precision Assay
11ms
Clinical application of the AMOY 9-in-1 panel to lung cancer patients. (PubMed, Lung Cancer)
AMOY had a higher success rate, shorter turnaround time, and higher detection rate than NGS panels. Only a limited number of mutant variants were included; thus be careful not to miss promising targetable driver mutations.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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AmoyDx® Pan Lung Cancer PCR Panel
1year
Clinical
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AmoyDx® Pan Lung Cancer PCR Panel
1year
AmoyDx Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for selpercatinib RET fusion positive NSCLC (GlobeNewswire)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today 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 RET fusion-positive non-small cell lung cancer ('NSCLC'), for selpercatinib capsules 40 mg and 80 mg. The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
over1year
AmoyDx® Pan Lung Cancer PCR Panel approved in Japan as a companion diagnostic for LUMAKRAS® (Sotorasib) (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA')...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 Amgen’s LUMAKRAS® (sotorasib), for patients with KRAS G12C-mutated, unresectable, advanced and/or recurrent non-small-cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
over1year
Performance of AmoyDx HER2 mutation detection kit and AmoyDx Pan Lung Cancer PCR Panel for detection of com-mon HER2 and/or EGFR mutations (ECP 2022)
In March 2019, AstraZeneca entered into a global development and commercialization collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (T-DXd; DS-8201)... Detection of rare mutations require sensitive and specific diagnostic assays. AmoyDx HER2 Mutation Detection Kit demonstrated robust performance in detecting representa-tive HER2 indel and single nucleotide variant mutations at low frequencies. The AmoyDx Pan Lung Cancer PCR assay showed similarly robust and sensitive detection of the common HER2 A775_G776insYVMA indel in addition to detecting clinically relevant EGFR mutations.
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KIT (KIT proto-oncogene, receptor tyrosine kinase)
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EGFR mutation • EGFR L858R • EGFR exon 19 deletion • HER-2 V777L • HER-2 exon 20 YVMA insertion • HER-2 A775
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AmoyDx® Pan Lung Cancer PCR Panel • AmoyDx® HER2 Mutation Detection Kit
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Enhertu (fam-trastuzumab deruxtecan-nxki)
over1year
MHLW approves AmoyDx® Pan Lung Cancer PCR Panel as companion diagnostic for Rozlytrek® (entrectinib) in Japan (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA')...announced that the AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel') had been approved by the Ministry of Health, Labour and Welfare (MHLW) as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer (NSCLC) for Rozlytrek®...The AmoyDx® PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping) for eleven associated targeted therapies in NSCLC."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
over1year
Alercell® to distribute Amoy Diagnostics’ molecular cancer tests (Alercell Press Release)
"Alercell® announced today that it has entered into a master distribution agreement with Amoy Diagnostics Co., Ltd (AmoyDx)...The master distribution agreement enables Alercell® to introduce to the United States market several innovative DNA sequencing cancer tests...The first tests to be introduced under the Agreement include: Pan Lung Cancer PCR Panel, EML4-ALK Fusion Gene Detection Kit, BRCA Pro Panel, and the Human Papillomavirus (HPV) Genotyping Detection Kit. These molecular diagnostic tests are all introduced as RUOs (Research Use Only) and are the most advanced next generation DNA sequencing tests in various fields to tackle, Lung Cancer, Breast Cancer , Ovarian Cancer and Cervical Cancer screening."
Licensing / partnership
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AmoyDx® Pan Lung Cancer PCR Panel • AmoyDx® BRCA Pro Panel • AmoyDx® EML4-ALK Fusion Gene Detection Kit • AmoyDx® Human Papillomavirus (HPV) Genotyping Detection Kit
almost2years
Filing notice for a manufacturing and marketing application for AmoyDx® Pan Lung Cancer PCR Panel as a companion diagnostic for a drug targeting RET fusion-Positive non-small cell lung cancer (AmoyDx Press Release)
"Riken Genesis Co., Ltd...Amoy Diagnostics Co., Ltd...Precision Medicine Asia Co., Ltd...announced that in April 2022, AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel'), an in vitro diagnostic reagent for multiple antineoplastic agents, was filed in Japan as a companion diagnostic for Retevmo (selpercatinib)...The aim of this application is to obtain approval as a companion diagnostic for RET fusion-positive non-small cell lung cancer (“NSCLC”), for Retevmo capsules 40 mg and 80 mg (common name: selpercatinib) marketed by Eli Lilly Japan K.K."
Japanese regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
2years
Notice concerning application for partial revision of manufacturing and marketing approval of companion diagnostic reagent for the AmoyDx® Pan Lung Cancer PCR Panel (AmoyDx Press Release)
"Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., ('AmoyDx') and Precision Medicine Asia Co., Ltd. ('PREMIA') today announced that an application for partial revision of manufacturing and marketing approval for AmoyDx® Pan Lung Cancer PCR Panel (the 'AmoyDx PLC Panel'), an in vitro diagnostic reagent for multiple antineoplastic agents, was submitted in February 2022...The aim of the Application for Partial Change is to obtain approval as a companion diagnostic for ROS1 fusion genes, for the anti-tumor agent/tyrosine kinase inhibitor Rozlytrek® capsules 100 mg and 200 mg (common name: Entrectinib), marketed by Chugai Pharmaceutical Co., Ltd."
Non-US regulatory
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AmoyDx® Pan Lung Cancer PCR Panel
2years
AmoyDx announces its PLC panel adopted as companion diagnostic for brigatinib in Japan (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd...today announced that the AmoyDx Pan Lung Cancer PCR Panel (the 'PLC Panel') has been adopted by Takeda Pharmaceutical Company Limited in Japan as one of the companion diagnostics for Brigatinib, its tyrosine kinase inhibitor for identifying ALK+ patients with non-small cell lung cancer (NSCLC)."
Clinical
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AmoyDx® Pan Lung Cancer PCR Panel
2years
AmoyDx and PREMIA announce the commercial launch of the AmoyDx® Pan Lung Cancer PCR Panel in Japan (AmoyDx Press Release)
"Amoy Diagnostics Co., Ltd and PREMIA Holdings (HK) Limited...announced the commercial launch of the AmoyDx® Pan Lung Cancer PCR Panel (the 'PLC Panel') in Japan as a reimbursed companion diagnostic for multiple anti-cancer agents. AmoyDx is the inventor and manufacturer and PREMIA the developer of the PLC Panel in Japan."
Launch Japan
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AmoyDx® Pan Lung Cancer PCR Panel
almost3years
[VIRTUAL] Impact of rapid multigene assays with short turnaround time (TAT) on the development of precision medicine for non-small cell lung cancer (NSCLC). (ASCO 2021)
Both the 9-in-1 test and Genexus/OPA had short TATs (3−4 days), high success rates (96−98%) and good concordance (95−98%) compared with another NGS assay (OCA) . These rapid multi-gene assays highly contributed to enabling precision medicine and the development of targeted therapies for advanced NSCLC.
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) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NRG1 (Neuregulin 1)
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BRAF V600E • BRAF V600 • NTRK3 fusion • RET fusion • ALK fusion • ROS1 fusion • NRG1 fusion • ALK-ROS1 fusion • NRG1 fusion
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AmoyDx® Pan Lung Cancer PCR Panel • Oncomine Precision Assay
over3years
[VIRTUAL] Lung NSCLC Molecular Diagnostic Comparison Between NGS and Multiplex PCR Assays (IASLC-WCLC 2020)
There was high concordance rate of the results between the assays. RNA quality in FFPE may show some limitations and performed better on the PCR panel. Both assays have their own advantages.
Next-generation sequencing
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AmoyDx® Pan Lung Cancer PCR Panel