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TEST:
FusionPlex® Dx

Type:
CE Marked
Related tests:
Evidence

News

1m
Comparison of Clinical Sensitivity for Kinase Fusion Detection in Thyroid Carcinoma by Paired Primer Targeted Methods (AMP 2024)
AFP, the targeted, breakpoint/fusion partner agnostic panel, outperformed 3 other established panels using real-world, fusion-driven thyroid cancers by an average detection frequency of 39%. Such findings demonstrate the importance in sequencing panel selection for fusion-driven thyroid cancer detection, and the potential downstream consequences for diagnostic utility and therapeutic intervention.
Clinical
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BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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NTRK1 fusion • FGFR2 fusion • ALK fusion
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FusionPlex® Dx • Illumina Focus Panel • Oncomine Focus Assay
1m
Clinical Validation of the Archer FUSION Plex Pan Solid Tumor v2 Assay on the Ion Torrent GeneXus System (AMP 2024)
Our AFPST assay with the Ion Torrent GeneXus sequencing is clinically validated as a highly accurate, sensitive, and specific assay for detecting gene fusions in solid tumors and sarcomas. It provides clinical utility in classification and therapy selection for patients with solid tumors and sarcomas. Our validation study and institutional experience suggest the Ion torrent GeneXus System is fully compatible with the Archer FUSIONPlex assay and analysis.
Clinical
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FusionPlex® Dx • FusionPlex® Pan Solid Tumor v2 panel
1m
Prevalence, Treatment, and Outcomes of Real-World Fusion/Isoform-Positive Non-small-Cell Lung Cancer in Southern Alberta (AMP 2024)
Archer FusionPlex testing is a sensitive method of identifying recurrent and novel alterations in lung adenocarcinomas that are therapeutically actionable. Assessment of fusion/isoform-driven tumors demonstrates these alterations are acted upon. Public funding for all level 1 targeted therapies should be considered if the maximum benefit is to be derived from biomarker testing.
Clinical • Real-world evidence • Real-world
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ALK (Anaplastic lymphoma kinase) • NRG1 (Neuregulin 1) • NKX2-1 (NK2 Homeobox 1)
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ALK fusion • NRG1 fusion
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FusionPlex® Dx
1m
Evaluation of the QIAxcel Connect System for NGS Library Prep QC Analysis: Experience from a Clinical Diagnostic Laboratory (AMP 2024)
We successfully assessed the performance of the QIAxcel Connect system for NGS library prep QC analysis. In addition, employing this system significantly diminished the utility of the library quantification from testing each individual library to testing 1 pooled library for each panel, and subsequently reduced reagent cost, labor cost, workflow complexity, and potential human errors.
Clinical • Next-generation sequencing
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FusionPlex® Dx • FusionPlex® Pan Solid Tumor v2 panel • OncoReveal™ Solid Tumor Panel • oncoReveal™ Solid Tumor v2 Panel
2ms
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)
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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)
2ms
Prospective study of the real impact of fusion centered genomic assays in patient management in a national collaborative group: the GETHI-XX-16 study. (PubMed)
Despite the growing knowledge of cancer biology and its translation to drug development, the overall impact of personalized treatments remains low. Access to comprehensive molecular tests covering properly all known actionable alterations and programs for a wide access to targeted therapies seem to be critical steps.
Journal
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Trailblaze Pharos™ • FusionPlex® Dx • FusionPlex® Pan Solid Tumor v2 panel
2ms
Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary Results From the Lung Cancer Cohort of the FPG500 Program. (PubMed, JCO Precis Oncol)
P=N/A; The early data of the FPG program (NSCLC cohort) support the implementation of CGP and MTB in clinical practice to grant access to patients harboring actionable molecular alterations to the most effective and individualized available treatment options, thus improving their survival outcomes.
Journal • IO biomarker • Metastases
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TruSight Oncology 500 Assay • Archer® FusionPlex® Lung Kit • FusionPlex® Dx • Oncomine Focus Assay
3ms
TP53 (Tumor protein P53) • WT1 (WT1 Transcription Factor) • CD36 (thrombospondin receptor) • EP300 (E1A binding protein p300) • XIAP (X-Linked Inhibitor Of Apoptosis) • CDKN2C (Cyclin Dependent Kinase Inhibitor 2C)
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WT1 mutation
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Archer® FusionPlex® Acute Lymphoblastic Leukemia (ALL) • FusionPlex® Dx • LymphoTrack® Dx IGH Assay
3ms
RNA-based multiplex polymerase chain reaction and sequencing to detect fusion genes in melanoma (ESMO Asia 2024)
Conclusions The Archer® FUSIONPlex® custom panel detected fusion genes in 10% of driver gene-negative melanomas. Combining DNA- and RNA-based multiplex sequencing is useful to identify potentially targetable gene alterations.
Polymerase Chain Reaction • IO biomarker
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NF1 (Neurofibromin 1) • MERTK (MER Proto-Oncogene, Tyrosine Kinase) • ETV1 (ETS Variant Transcription Factor 1) • MAD1L1 (Mitotic Arrest Deficient 1 Like 1) • MAP3K8 (Mitogen-Activated Protein Kinase Kinase Kinase 8) • RASGRF1 (Ras Protein Specific Guanine Nucleotide Releasing Factor 1) • MEGF8 (Multiple EGF Like Domains 8) • RASGRF2 (Ras Protein Specific Guanine Nucleotide Releasing Factor 2)
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BRAF mutation • KIT mutation • NF1 mutation • BRAF fusion • CIC deletion
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
3ms
Synovial sarcoms presenting atypical FISH positive pattern with loss of green signal. Molecular characteristics of 2 new cases and systematic review of the literature (ECP 2024)
Atypical SS18-break apart FISH pattern with loss of green signal should be interpreted as a peculiar unbalanced rearrangement of the SS18 gene and subsequent SS18-SSX fusion (IHC or/and NGS) test should be recommended in such cases. Reseach are partially supported by grant of the The National Centre for Research and Development no. GOSPOSTRATEG-VI/0016/2021.
Clinical • Review
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SS18 (SS18 Subunit Of BAF Chromatin Remodeling Complex) • SSX1 (SSX Family Member 1)
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SS18-SSX fusion
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
3ms
Intraosseous spindle cell rhabdomyosarcoma with FET (EWSR1)- TFCP2 and LOC101929418-ALK fusions: a case report and literature review (ECP 2024)
After unsuccessful chemotherapy, Alectinib (ALK inhibitor) combined with radiotherapy was initiated... Intraosseous spindle cell rhabdomyosarcoma (RMS) with TFCP2 rearrangement is a highly aggressive tumour with an early onset, fast progression and poor response to standard therapies. Our case, one of the few cases described with two gene fusions, contributes to understanding its molecular profile. Further clinical studies are required to explore the efficacy of targeted therapy for ALK and for the development of new effective treatment approaches.
Clinical • Review • Case report
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EWSR1 (EWS RNA Binding Protein 1) • TFCP2 (Transcription Factor CP2) • MYOD1 (Myogenic Differentiation 1) • NCOA2 (Nuclear Receptor Coactivator 2)
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ALK fusion
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
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Alecensa (alectinib)
3ms
Myositis ossificans: rare paediatric case diagnosed with FNAB and confirmed by RNA genotyping of cytology sample (ECP 2024)
When myositis ossificans presents with typical clinical history and a clear zonal pattern on imaging, diagnosis is relatively straightforward. However, in early lesions without typical clinical features the diagnosis may be more challenging and sometimes requires a biopsy. Our case shows that FNAB with supported by immunocytochemistry and RNA genotyping proving COL1A1::USP6 fusion allows accurate diagnosis in less than 6 days and implicates the potential use of molecular methods on FNAB samples of soft tissue lesions.
Clinical • Cytology
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COL1A1 (Collagen Type I Alpha 1 Chain) • USP6 (Ubiquitin Specific Peptidase 6) • SATB2 (SATB Homeobox 2)
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
3ms
A report of an exceptional case of rhabdomyosarcoma of the tongue harbouring THBS1::ALK fusion and literature review (ECP 2024)
Rhabdomyosarcomas are a heterogenous group of malignant neoplasms rarely occurring in adults. Immunohistochemical ALK-positivity has been described in RMS, however underlying ALK rearrangements are rare events. This is the first case harboring THBS1::ALK fusion, which was previously described in inflammatory myofibroblastic tumours.
Clinical • Review
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ALK (Anaplastic lymphoma kinase) • THBS1 (Thrombospondin 1) • MYOD1 (Myogenic Differentiation 1)
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ALK rearrangement • ALK fusion
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
3ms
CD34-positive spindle cell tumour with FGFR1::TACC1 fusion: entity of uncertain behaviour (ECP 2024)
In this particular case, the immunohistochemical and molecular results support a diagnosis of a fibroblastic/myofibroblastic tumour of uncertain behaviour. Notably, there have been no reported cases in the literature of a soft tissue tumour harboring FGFR1::TACC1 fusion as a primary occurrence in this anatomical location. The patient remains in good health without any evidence of disease recurrence at the 5-month follow-up post-surgical intervention.
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR1 (Fibroblast growth factor receptor 1) • MDM2 (E3 ubiquitin protein ligase) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • CD34 (CD34 molecule) • MME (Membrane Metalloendopeptidase) • COL1A1 (Collagen Type I Alpha 1 Chain) • NTRK (Neurotrophic receptor tyrosine kinase) • STAT6 (Signal transducer and activator of transcription 6) • SS18 (SS18 Subunit Of BAF Chromatin Remodeling Complex) • TACC1 (Transforming Acidic Coiled-Coil Containing Protein 1)
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MDM2 amplification • FGFR1 fusion • CD34 positive
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
3ms
Landscape, Management & Outcome of Real-World Fusion-positive Non-Small Cell Lung Cancer (NSCLC) (IASLC-WCLC 2024)
These findings also reveal the low uptake of approved targeted therapies when self-funding is required for access. Inclusion of NGS-based genomic profiling and targeted therapies as part of standard of care within the public healthcare system supports appropriate clinical management to optimize patient outcome among those with actionable oncogenic fusions.
Clinical • Real-world evidence • IO biomarker • Real-world
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BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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MET exon 14 mutation • FGFR2 fusion • ALK fusion
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FusionPlex® Dx
3ms
Clinical Validation of a Custom-designed Large Gene Fusion Panel for Solid Tumors (AMP 2024)
This custom-designed NGS fusion assay demonstrated robust sequencing performance and excellent analytical accuracy, achieving 100% sensitivity, specificity, and reproducibility on 72 validation samples. The assay's design flexibility allowed for the addition of new targets based on local needs. It also enables simultaneous detection of fusions and hotspot variants in a single assay.
Clinical
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DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
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FusionPlex® Dx
5ms
Intrinsic ALK-TKI Resistance Due to Met-Coamplification in ALK+ NSCLC, Effectively Treated by Alectinib-crizotinib Combination (IASLC-WCLC 2024)
Yet, to our knowledge, we present herein the first case of ALK + NSCLC rapidly progressing on 1 st line Brigatinib treatment due to de novo MET- amplification. The recognition of this mechanism of ALK-TKI resistance by FISH, especially in NGS-negative cases, should be considered before initiating 1 st line treatment. This is of clinical importance, as effective combined therapy with ALK-TKI and MET-inhibitor is feasible.
ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase) • EML4 (EMAP Like 4)
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TP53 mutation • MET amplification • ALK rearrangement • MET overexpression • EML4-ALK fusion • ALK fusion • MET expression • ALK amplification • TP53 G245S
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Oncomine™ Comprehensive Assay v3M • Archer® FusionPlex® Lung Kit • FusionPlex® Dx
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Xalkori (crizotinib) • Alecensa (alectinib) • Alunbrig (brigatinib)
6ms
Fusion partner agnostic approaches improve detection of targetable gene fusions in thyroid cancers (ETA 2024)
Additional work will need to quantify the diagnostic utility of agnostic sequencing approaches against both broad scale and hot-spot panels as they relate to metrics of cost-effectiveness and theranostic consequence. Word count: 395/400
BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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FusionPlex® Dx • Oncomine Focus Assay
7ms
Gene expression and mutational profiling of NSCLC in relation to KRAS G12C. (ERS 2024)
Further research is necessary to confirm these observations. Project 3.9/2022
Archer® FusionPlex® Lung Kit • FusionPlex® Dx
7ms
Recurrent and novel fusions detected by targeted RNA sequencing as part of the diagnostic workflow of soft tissue and bone tumours. (PubMed, J Pathol Clin Res)
In the latter subgroup, four novel fusion transcripts were found for which the clinical relevance remains unclear: NAB2::NCOA2, YAP1::NUTM2B, HSPA8::BRAF, and PDE2A::PLAG1. Overall, targeted RNA-seq has proven extremely valuable in the diagnostic workflow of soft tissue and bone tumours.
Journal
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BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • BCOR (BCL6 Corepressor) • EWSR1 (EWS RNA Binding Protein 1) • YAP1 (Yes associated protein 1) • NUTM2B (NUT Family Member 2B) • PLAG1 (PLAG1 Zinc Finger) • NAB2 (NGFI-A Binding Protein 2) • NCOA2 (Nuclear Receptor Coactivator 2) • HSPA8 (Heat Shock Protein Family A (Hsp70) Member 8)
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ALK fusion
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FusionPlex® Dx
7ms
Molecular analysis of apocrine mixed tumors and cutaneous myoepitheliomas: a comparative study confirming a continuous spectrum of one entity with near-ubiquitous PLAG1 and rare mutually exclusive HMGA2 gene rearrangements. (PubMed, Virchows Arch)
In addition, we identified a novel PXDNL::PLAG1 fusion and suggested that rare cases may harbor HMGA2 gene alterations which seem to be mutually exclusive with PLAG1 gene fusions. The relatedness of these tumors to salivary gland myoepithelial neoplasms and distinctness from eccrine mixed tumors and other skin and soft tissue myoepithelial neoplasms with EWSR1/FUS fusions is discussed.
Journal
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CTNNB1 (Catenin (cadherin-associated protein), beta 1) • EWSR1 (EWS RNA Binding Protein 1) • FUS (FUS RNA Binding Protein) • HMGA2 (High mobility group AT-hook 2) • NDRG1 (N-Myc Downstream Regulated 1) • PLAG1 (PLAG1 Zinc Finger) • PXDNL (Peroxidasin Like) • TRPS1 (Transcriptional Repressor GATA Binding 1)
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HMGA2 expression
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FusionPlex® Dx
8ms
Disparity in oncology therapy access and differences in clinical pathological features and outcomes in indigenous population lung cancer (LC): A retrospective study from Martinique. (ASCO 2024)
The lower overall survival rate than expected in this cancer context address the question of disparity population. One-third of LC metastatic patients did not receive systemic therapy. The local inadequacy of care pathways, leading to disparities in access to imaging, may explain the delays and poorer prognosis.
Retrospective data • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NRG1 (Neuregulin 1) • NUTM1 (NUT Midline Carcinoma Family Member 1)
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Archer® FusionPlex® Lung Kit • FusionPlex® Dx
8ms
Recurrent USP6 rearrangement in a subset of atypical myofibroblastic tumours of the soft tissues: low-grade myofibroblastic sarcoma or atypical/malignant nodular fasciitis? (PubMed, Histopathology)
Our findings support the notion that among soft-tissue neoplasms with fibroblastic/myofibroblastic phenotype, USP6 rearrangement is not limited to benign tumours, and warrants further investigation of genetic changes in myofibroblastic sarcomas.
Journal
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THBS2 (Thrombospondin 2) • USP6 (Ubiquitin Specific Peptidase 6)
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Archer® FusionPlex® Sarcoma kit • FusionPlex® Dx
12ms
Sarcomas with RAD51B Fusions are Associated with a Heterogeneous Phenotype. (PubMed, Mod Pathol)
Our results expand the spectrum of sarcomas with RAD51B-fusions, demonstrating variable clinical presentations, morphologic spectrum, and fusion partners. These tumors have a predilection for a uterine location, with either LMS, PEComa or undifferentiated phenotypes, and are associated with an aggressive clinical course.
Journal
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RAD51B (RAD51 Paralog B) • TSC1 (TSC complex subunit 1) • HMGA2 (High mobility group AT-hook 2)
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FusionPlex® Dx
1year
Genetic and Cytometric Characteristics of Pediatric B-Other Acute Lymphoblastic Leukemia Cohort (ASH 2023)
"Our study shows population-based frequencies of novel ALL subtypes, including both recurrent and novel genetic aberrations. This data widens our knowledge on the interplay between molecular aberrations and clinical course of the disease and provides clues for diagnostics optimization."
Clinical
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • FGFR1 (Fibroblast growth factor receptor 1) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • RUNX1 (RUNX Family Transcription Factor 1) • CD74 (CD74 Molecule) • KMT2A (Lysine Methyltransferase 2A) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • ETV6 (ETS Variant Transcription Factor 6) • CRLF2 (Cytokine Receptor Like Factor 2) • PAX5 (Paired Box 5) • STAT3 (Signal Transducer And Activator Of Transcription 3) • IL2RA (Interleukin 2 receptor, alpha) • CD34 (CD34 molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • IL7R (Interleukin 7 Receptor) • CRKL (CRK Like Proto-Oncogene, Adaptor Protein) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1) • CHD1 (Chromodomain Helicase DNA Binding Protein 1) • SOCS1 (Suppressor Of Cytokine Signaling 1) • CD99 (CD99 Molecule) • SSBP2 (Single Stranded DNA Binding Protein 2) • BLNK (B Cell Linker)
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FGFR1 fusion • MLL fusion
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FusionPlex® Dx
1year
Analytical Performance and Concordance with Next-Generation Sequencing of a Rapid, Multiplexed dPCR Panel for the Detection of DNA and RNA Biomarkers in Non-Small-Cell Lung Cancer. (PubMed, Diagnostics (Basel))
The population prevalence-based coverage ranged from 89.2% to 100.0% across targets and exceeded 99.0% in aggregate. The assay demonstrated >97% concordance with respect to the comparator method.
Journal • Next-generation sequencing • Discordant
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ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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NTRK1 fusion • MET exon 14 mutation
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FusionPlex® Dx • Oncomine Precision Assay
1year
Deep and Durable Cytogenetic and Molecular Responses with Pemigatinib in Myeloid/Lymphoid Neoplasms with Fibroblast Growth Factor Receptor 1 Rearrangement: The Fight-203 Study (ASH 2023)
Several new FGFR1 fusion partner genes, including C14orf93, CCDC6, and ETV6 were identified with NGS and PCR profiling. Pemigatinib treatment resulted in marked decreases in the percentages of cells with the FGFR1 rearrangement on FISH, as well as 2–3 log reductions in FGFR1 fusion transcripts in patients with MLNFGFR1. Further investigations are ongoing to determine the relationship between pemigatinib dose intensity and the depth and durability of molecular response.
FGFR1 (Fibroblast growth factor receptor 1) • CCDC6 (Coiled-Coil Domain Containing 6) • ETV6 (ETS Variant Transcription Factor 6) • TRIM24 (Tripartite Motif Containing 24)
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FGFR1 fusion • FGFR1 rearrangement
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FusionPlex® Dx
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Pemazyre (pemigatinib)
over1year
SECONDARY REARRANGEMENT CREATING A PLEC-EML4-ALK DOUBLE FUSION AS A MECHANISM OF RESISTANCE TO CRIZOTINIB IN AN EML4-ALK-POSITIVE INFLAMMATORY MYOFIBROBLASTIC TUMOR (CTOS 2023)
Secondary rearrangement involving EML4-ALK which places the fusion gene under control of a new promoter may be a novel mechanism of resistance to crizotinib in IMT (and potentially other ALK-fusion-driven malignancies). Alectinib, a more potent ALK inhibitor, overcame resistance in this case. More broadly, this study exemplifies the importance of molecular testing in the setting of resistance to targeted therapy to inform clinical decision making.
ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
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ALK positive • ALK rearrangement • EML4-ALK fusion • ALK fusion • KIT fusion
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FusionPlex® Dx • FusionPlex® Pan Solid Tumor v2 panel
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Xalkori (crizotinib) • Alecensa (alectinib)
over1year
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
over1year
Molecular Characteristics of Non-Small Cell Lung Cancer with MET Fusions (IASLC-WCLC 2023)
MET fusions are a rare, but potentially actionable, genomic alteration. Our study provides a comprehensive characterization of MET fusions in NSCLC, revealing their diverse fusion partners and co-occurring genomic alterations. Further research is warranted to elucidate the clinical implications of MET fusions in the treatment of various types of cancer, including lung cancer.
Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • KIF5B (Kinesin Family Member 5B) • CAPZA2 (Capping Actin Protein Of Muscle Z-Line Subunit Alpha 2) • GPRC5C (G Protein-Coupled Receptor Class C Group 5 Member C)
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PD-L1 expression • BRAF V600E • KRAS mutation • EGFR mutation • TMB-H • PD-L1 overexpression • BRAF V600 • EGFR L858R • MET amplification • RET fusion • MET exon 14 mutation • EGFR mutation + KRAS mutation • BRAF L597Q • MET fusion • EGFR E746 • KRAS Q61L • PD-L1-L • BRAF L597
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PD-L1 IHC 22C3 pharmDx • FusionPlex® Dx • MI Tumor Seek™
2years
Integrated DNA Technologies Acquires ArcherDX Next Generation Sequencing Research Assays from Invitae Corporation (Integrated DNA Technologies Press Release)
"Integrated DNA Technologies, Inc....announced it closed on the purchase of Next Generation Sequencing (NGS) research assays from Invitae Corporation (NYSE: NVTA) under the trademarked name Archer. The integration of IDT’s portfolio with the acquired NGS research assays—which have been foundational in researching novel cancer fusions—will empower labs with an all-in-one solution to uncover biomarkers and advance cancer discoveries. The transaction enables IDT to expand its existing operations, build upon the legacy Archer portfolio, and welcome more than 100 new associates globally....Transaction Details-IDT purchased Archer NGS research assays—which reported high double-digit growth since 2019—from Invitae for cash consideration of approximately $48 million, subject to certain adjustments. The transaction is structured as an asset deal and includes a license to intellectual property related to the AMP technology."
M&A
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Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • Archer® FusionPlex® Acute Lymphoblastic Leukemia (ALL) • Archer® FusionPlex® Lung Kit • Archer® FusionPlex® Lymphoma • Archer® FusionPlex® Myeloid Kit • Archer® FusionPlex® Oncology Research Kit • Archer® FusionPlex® Sarcoma kit • Archer® VariantPlex® Comprehensive Thyroid and Lung (CTL) kit • Archer® VariantPlex® Myeloid panel • Archer® VariantPlex® Solid Tumor Kit • FusionPlex® Dx • FusionPlex® Pan Solid Tumor v2 panel • FusionPlex™ Heme v2 panel • FusionPlex™ Pan-Heme panel • LiquidPlex™
almost3years
Invitae Launches its First CE-IVD Cancer Testing Kits In Europe (Invitae Press Release)
"Invitae...announced the availability of FusionPlex Dx® and LiquidPlex Dx™ in Europe, part of its industry-leading Anchored Multiplex PCR chemistry in-vitro diagnostic (IVD) products. Invitae is delivering essential high quality innovation for precision oncology in the fight against cancer."
Launch Europe
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FusionPlex® Dx • LiquidPlex™