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    TEST:
    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit

    Company:
    Integrated DNA Technologies
    Type:
    Laboratory Developed Test
    Related tests:
    5ms
    Tiered approach to molecular testing of thyroid fine needle aspiration samples may improve preoperative diagnosis. (PubMed, Eur J Surg Oncol)
    This is the first Australian study to demonstrate that pre-existing, non-proprietary NGS mutation and fusion panels can achieve high diagnostic specificity and positive predictive value for malignancy in indeterminate thyroid nodules. Furthermore, we propose exploration of using BRAF V600E testing to select patients for full NGS analysis.
    Journal
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    BRAF (B-raf proto-oncogene)
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    BRAF V600E • BRAF V600
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    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    1year
    KRAS G12C mutation in NSCLC in a small genetic center: insights into sotorasib therapy response potential. (PubMed, Sci Rep)
    Notably, patients harboring the G12C variant responded favorably to sotorasib medication. These results underscore the importance of mutational profiling and targeted therapeutic approaches in managing NSCLC, particularly highlighting the promising efficacy of sotorasib in G12C-mutated cases.
    Journal
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    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12D • KRAS G12V • KRAS G12
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    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • FusionPlex® Dx
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    Lumakras (sotorasib)
    1year
    Homologous recombination deficiency (HRD) in biliary carcinomas: clinical significance and correlation with platinum response (DGHO 2024)
    In second-line treatment, no difference between an Irinotecan-based regimen and re-exposure to platinum-based agents (12.36 vs 10.13 months; HR 0.92; P=0.85) could be observed (HR 1.45; P=0.35). HRRm BTC patients showed a potential advantage in OS following platinum-based first-line chemotherapy, presumably attributed to enhanced opportunities for targetable co-alterations. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.
    Clinical
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    HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • BAP1 (BRCA1 Associated Protein 1)
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    HRD
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    FoundationOne® CDx • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • TruSight Tumor 170 Assay
    |
    irinotecan
    1year
    Anaplastic lymphoma kinase (ALK)-positive histiocytosis with ALK-EML4 fusion – presentation as a pulmonary lesion (ECP 2024)
    The microscopic image, together with the results of immunohistochemical and molecular evaluation, confirms the diagnosis of ALK-positive histiocytosis. The reported case with ALK-EML4 rearrangement seems preferentially documented in lung location, as other reported cases so far have been confirmed.
    IO biomarker
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • BCL2 (B-cell CLL/lymphoma 2) • EML4 (EMAP Like 4) • CD20 (Membrane Spanning 4-Domains A1) • KIF5B (Kinesin Family Member 5B) • TNFRSF8 (TNF Receptor Superfamily Member 8) • WT1 (WT1 Transcription Factor) • TRIM33 (Tripartite Motif Containing 33) • IL2RA (Interleukin 2 receptor, alpha) • CD163 (CD163 Molecule) • TPM3 (Tropomyosin 3) • CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • DCTN1 (Dynactin Subunit 1) • ALK1 (Activin A Receptor Like Type 1) • NKX2-1 (NK2 Homeobox 1) • SOX10 (SRY-Box 10) • CD14 (CD14 Molecule) • VIM (Vimentin) • CD68 (CD68 Molecule) • CLTC (Clathrin Heavy Chain) • MME (Membrane Metalloendopeptidase) • CD31 (Platelet and endothelial cell adhesion molecule 1) • STAT6 (Signal transducer and activator of transcription 6) • TP63 (Tumor protein 63) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
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    ALK positive • ALK rearrangement • ALK fusion
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    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    over1year
    Homologous recombination repair (HRR) deficiency in biliary tract cancers: Clinical implications in subsequent therapy lines and correlation with platinum sensitivity (ESMO-GI 2024)
    A trend for a clinical benefit of second-line therapy with re-exposure to platinum-based agents as compared to irinotecan-based regimens was observed (HR= 0.79, 95%CI 0.34-1.8, P= 0.56)... Platinum-based chemotherapy associates with more favorable outcomes in HRRm BTC patients. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.
    Clinical
    |
    HRD (Homologous Recombination Deficiency)
    |
    FoundationOne® CDx • AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • TruSight Tumor 170 Assay
    |
    irinotecan
    2years
    The utility of next generation sequencing for KRAS gene variants prevalence in cytological and tissue samples in real-world NSCLC patients: A large single institution real-world study (ESMO Asia 2023)
    Tyrosine kinase inhibitors (TKIs)- sotorasib and adagrasib are approved for use in patients(pts) with KRASG12C variant. Conclusions The NGS is feasible for diagnosis of the KRAS mutations in real-world practice. The utility of both cytological and tissue testing is high for NGS profiling with comparable prevalence of the most frequent KRAS variants.
    Real-world evidence • Clinical • Next-generation sequencing • Real-world
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    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    |
    Lumakras (sotorasib) • Krazati (adagrasib)
    2years
    Molecular characterization of biliary tract cancer at a single comprehensive cancer center focusing on DNA damage repair genes. (DGHO 2023)
    Pathogenic alterations in DDR pathway genes were seen in 13.5% of the cases studied. DDR-deficient BTC patients showed a trend for better OS and TTE representing a potential subgroup that could benefit from targeted treatment strategies, like PARP-inhibitors. and more prospective data are needed.
    PARP Biomarker
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    TP53 mutation • KRAS mutation • BRAF mutation • PIK3CA mutation • FGFR2 mutation • FGFR2 fusion
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    AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    over2years
    EXPLORING THE IMPACT OF NGS ON DIAGNOSTICS AND TREATMENT OF SARCOMA: INSIGHTS FROM REAL-WORLD DATA ACROSS MULTIPLE INSTITUTIONS IN EUROPE (CTOS 2023)
    Various NGS technologies and platforms are increasingly used in oncology centers, primarily for therapeutic indications. Unlike most cancer types, the indication of NGS to provide some aid in diagnosis is paradigmatic in the case of sarcomas, given the pleiad and complexity of the histotypes of sarcomas. On the other hand, the therapeutic options for patients with sarcoma are limited, and NGS testing offers the promise of finding targetable alterations.
    Real-world evidence • Clinical • Tumor mutational burden • Next-generation sequencing • Real-world
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    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • RB1 (RB Transcriptional Corepressor 1) • MDM2 (E3 ubiquitin protein ligase) • CDK4 (Cyclin-dependent kinase 4) • EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor) • NTRK (Neurotrophic receptor tyrosine kinase) • STAT6 (Signal transducer and activator of transcription 6) • DUX4 (Double Homeobox 4) • NAB2 (NGFI-A Binding Protein 2)
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    TP53 mutation • PIK3CA mutation • TMB-L
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    FoundationOne® CDx • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
    over2years
    DNA damage repair pathways in biliary tract cancer: A new target for precision medicine? (ESMO 2023)
    DDR-deficient BTC patients showed a trend for better OS and TTE representing a potential subgroup that could benefit from targeted treatment strategies, like PARP-inhibitors. Moreover the slight benefit of DDR-mutated BTC under platinum-based therapy supports the hypothesis of better response of DDR-mutated tumours to platinum.
    PARP Biomarker
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    TP53 mutation • KRAS mutation • BRAF mutation • PIK3CA mutation • FGFR2 mutation
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    AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    over2years
    Next Generation Sequencing Analysis and its Benefit for Targeted Therapy of Lung Adenocarcinoma. (PubMed, Cancer Genomics Proteomics)
    As lung adenocarcinoma patients significantly benefit from targeted therapy, the assessment of mutational profiles using NGS could become a crucial approach in the routine management of oncological patients.
    Journal • Next-generation sequencing
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • EML4 (EMAP Like 4) • CD74 (CD74 Molecule)
    |
    EML4-ALK fusion • ALK fusion • ROS1 fusion • ALK-ROS1 fusion
    |
    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    |
    Alecensa (alectinib)
    over2years
    EGFR and ERBB2 exon 20 insertion/duplication in advanced non-small cell lung cancer: genomic profiling and clinicopathologic features. (PubMed, Front Oncol)
    US Food and Drug Administration has approved mobocertinib and amivantamab for targeting tumors with this aberration, but the number of comprehensive studies on ex20 ins/dup NSCLC is limited. NSCLCs harboring EGFR/ERBB2 ex20 ins/dup are rare and tend to be acinar predominant, negative for PD-L1, more frequent in non- or light smokers, and mutually exclusive with other driver mutations in NSCLC. The correlation of different EGFR/ERBB2 ex20 ins/dup variants and co-existing mutations with response to targeted therapy and the possibility of developing resistant mutations after mobocertinib treatment warrants further investigation.
    Journal • PD(L)-1 Biomarker • IO biomarker • EGFR exon 20 • HER2 exon 20 • Metastases
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • MSI (Microsatellite instability) • CDK4 (Cyclin-dependent kinase 4) • TYK2 (Tyrosine Kinase 2)
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    PD-L1 expression • EGFR mutation • EGFR L858R • HER-2 mutation • EGFR exon 19 deletion • EGFR exon 20 insertion • PD-L1 negative • CDK4 amplification • EGFR exon 20 mutation • HER-2 exon 23 mutation
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    PD-L1 IHC 22C3 pharmDx • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
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    Rybrevant (amivantamab-vmjw) • Exkivity (mobocertinib)
    almost3years
    Efficacy of Immunotherapy in Second-Line Treatment of KRAS-Mutated Patients with Non-Small-Cell Lung Cancer-Data from Daily Practice. (PubMed, Curr Oncol)
    Results A total of 96 pts with chemotherapy-pre-treated advanced NSCLC (CS III-IV) were qualified for nivolumab or atezolizumab treatment following a molecular diagnosis by the NGS and the exclusion of EGFR and ALK gene abnormalities. The treatment sequence, including molecularly targeted drugs such as sotorasib and adagrasib, is still discussed. The NGS is a valuable method to identify a variety of molecular abnormalities in patients with NSCLC in daily practice.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
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    KRAS mutation • EGFR mutation • KRAS G12C • KRAS wild-type • ALK mutation • RAS wild-type
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    Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit
    |
    Opdivo (nivolumab) • Tecentriq (atezolizumab) • Lumakras (sotorasib) • Krazati (adagrasib)