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    TEST:
    CancerTYPE ID®

    Company:
    Hologic
    Type:
    Laboratory Developed Test
    Related tests:
    Details
    Evidence

    News

    5ms
    Utility of gene expression–based cancer classification in diagnosis of malignant peritoneal mesothelioma (MPeM): Filling in the gaps in standard pathologic work-up for a rare cancer. (ASCO-GI 2024)
    In this cohort of CUP or uncertain diagnoses with a molecular cancer classification of malignant mesothelioma, we found huge variability and critical gaps in pathological work-up. Integration of molecular cancer classification using the 92-gene assay helped resolve this diagnostic uncertainty, further supporting its clinical utility to complement standard pathology. The impact of these findings goes beyond just MPeM and may benefit numerous pts with orphan cancers, who account for nearly 20% of all cancers diagnosed globally.
    CancerTYPE ID®
    9ms
    CUP-ONE trial: A prospective double-blind validation of molecular classifiers in the diagnosis of cancer of unknown primary and clinical outcomes (ESMO 2023)
    Conclusions CUP-ONE assessed accuracy of CTID Vs C-IHC with comparable outcomes but a higher assignment of Cholangiocarcinoma in CUP. Survival was better in the C/S subset but remains poor overall.
    Late-breaking abstract • Clinical data • Clinical
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    CancerTYPE ID®
    2years
    Integration of molecular cancer classification and NGS to identify patients with metastatic cancer eligible for BRAF inhibitors. (ASCO 2022)
    This analysis identified patients with metastatic cancer with actionable BRAF mutations eligible for FDA-approved therapy, and patients who may be eligible for investigational BRAF inhibitors based on tumor type and mutation status. Notably, cancer type identification is critical given that FDA-approved BRAF inhibitor treatment regimens vary based on the tumor-specific indication. These findings support the clinical utility of molecular tumor type classification by CancerTYPE ID combined with biomarker profiling to identify additional treatment options for patients with metastatic cancer.BRAF inhibitor eligibility: *FDA-approved; †Investigational; §No FDA-approved nor investigational
    Clinical • Next-generation sequencing
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    BRAF mutation
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    CancerTYPE ID®
    2years
    Benefit of Gene Expression Profiling in Gastrointestinal Neuroendocrine Tumors of Unknown Primary Origin. (PubMed, Anticancer Res)
    These cases demonstrated that the CancerTYPE ID test was able to resolve challenging diagnoses for primary and metastatic NENs. These cases emphasize the clinical need of utilizing a GEP-based assay for determining the anatomic site of origin and NEN subtyping, both essential for the appropriate clinical management of NENs.
    Journal
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    CancerTYPE ID®
    2years
    A Case of ALK Positive Adenocarcinoma of Unknown Primary with Good Response to Alectinib (ATS 2022)
    No new metastatic lesions were noted and there was no evidence of primary neoplasm in the chest. Positive ALK rearrangement in patients with CUP provides a target for ALK-inhibiting agents such as alectinib with beneficial outcomes similar to treatment of primary ALK-positive non-small cell lung cancer.
    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) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NKX2-1 (NK2 Homeobox 1) • CDX2 (Caudal Type Homeobox 2) • KRT19 (Keratin 19) • GATA3 (GATA binding protein 3) • NAPSA (Napsin A Aspartic Peptidase) • PAX8 (Paired box 8) • CA 19-9 (Cancer antigen 19-9)
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    KRAS mutation • BRAF mutation • HER-2 negative • ALK positive • MET amplification • ALK rearrangement • RET rearrangement • EGFR negative
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    CancerTYPE ID®
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    Alecensa (alectinib)
    over2years
    Integration of molecular cancer classification and NGS to identify metastatic patients eligible for IDH inhibitors. (ASCO-GI 2022)
    Ivosidenib was recently approved for IDH1-mutated cholangiocarcinoma based on improved progression-free survival (PFS) and overall survival (OS)... These findings support the clinical utility of molecular tumor type classification combined with biomarker profiling to identify approved or investigational treatment options. The MOSAIC analysis identified metastatic patients with actionable aberrations (IDH1) eligible for FDA-approved therapy, as well as those who may be eligible for investigational IDH inhibitor therapies based on tumor type and IDH1/2 mutation status. As new and approved IDH inhibitors are evaluated for efficacy, increased patient selection may be afforded through this approach in additional tumor types.
    Clinical • Next-generation sequencing
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
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    IDH1 mutation • IDH2 mutation
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    CancerTYPE ID®
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    Tibsovo (ivosidenib)
    over2years
    Integration of molecular cancer classification and next-generation sequencing to identify metastatic patients eligible for immune checkpoint inhibitors (SITC 2021)
    Further, since there is no relationship between PD-L1 and TMB for different tumor types, accurate tumor type identification is necessary to select the most appropriate biomarker. This highlights the clinical utility of CancerTYPE ID combined with multimodal biomarker testing to guide ICI treatment and predict response based on tumor type identification, which may improve outcomes in patients with metastatic cancer.
    Checkpoint inhibition • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Next-generation sequencing
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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    PD-L1 expression • TMB-H
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    CancerTYPE ID®
    over2years
    [VIRTUAL] Integration of Molecular Cancer Classification and NGS to Identify Metastatic Cancer Patients Eligible For Lung Cancer Directed Therapy (IASLC-WCLC 2021)
    "Mutations identified included genes for which targeted therapies are available, including capmatinib for MET exon 14 skipping mutations and dabrafenib for BRAF V600E mutations. Multimodal biomarker testing for pan-TRK identified 1 (1.5%) lung adenocarcinoma, 7 (15.2%) SqCC and 6 (24.0%) small/large cell carcinoma cases, which were eligible for larotrectinib and entrectinib...Conclusion Analysis of the MOSAIC database identified a subset of patients with metastatic cancers eligible for lung cancer directed targeted therapy and immunotherapy based on tumor type, genetic alterations, and PD-L1 expression. Molecular profiling combined with cancer classification may lead to improved therapy options for patients with advanced disease of unknown primary and may provide further evidence for subsequent combination trials of targeted therapies or immunotherapies to improve patient outcomes."
    Clinical
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    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) • MET (MET proto-oncogene, receptor tyrosine kinase) • BRCA2 (Breast cancer 2, early onset) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • STK11 (Serine/threonine kinase 11) • RB1 (RB Transcriptional Corepressor 1) • ARID1A (AT-rich interaction domain 1A) • KEAP1 (Kelch Like ECH Associated Protein 1) • RUNX1 (RUNX Family Transcription Factor 1) • KMT2D (Lysine Methyltransferase 2D) • LRP1B (LDL Receptor Related Protein 1B) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • KMT2C (Lysine Methyltransferase 2C) • TSC2 (TSC complex subunit 2) • FAT1 (FAT atypical cadherin 1) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • RANBP2 (RAN Binding Protein 2) • ARID2 (AT-Rich Interaction Domain 2) • DICER1 (Dicer 1 Ribonuclease III) • EPHA5 (EPH Receptor A5)
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    PD-L1 expression • TP53 mutation • BRAF V600E • KRAS mutation • BRAF V600 • MET exon 14 mutation • ALK fusion
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    CancerTYPE ID®
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    Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • Tabrecta (capmatinib)
    3years
    [VIRTUAL] Integration of molecular cancer classification and next-generation sequencing to identify metastatic patients eligible for PARP inhibitors. (ASCO 2021)
    Funding: Biotheranostics, Inc Background: Olaparib, rucaparib, and niraparib are 3 poly-ADP-ribose polymerase inhibitors (PARPi) approved by the FDA for ovarian, breast, pancreatic, prostate, fallopian tube and peritoneal cancers with BRCA mutations . These findings in metastatic patients demonstrate the clinical utility of tumor type identification combined with molecular biomarker profiling, leading to additional options for patients with advanced disease . Specifically, analysis of the MOSAIC database identified a subset of patients with metastatic cancers eligible for PARPi therapy based on tumor type and BRCA mutation status . As new and approved PARPi are evaluated for efficacy in additional tumor types, patients can be identified that may be eligible for these targeted cancer drugs.
    Clinical • Tumor mutational burden • PARP Biomarker • BRCA Biomarker • Next-generation sequencing
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    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
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    BRCA2 mutation • BRCA1 mutation • BRCA mutation
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    CancerTYPE ID®
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    Lynparza (olaparib) • Zejula (niraparib) • Rubraca (rucaparib)
    over3years
    Defining a Distinct Immunotherapy Eligible Subset of Patients with Cancer of Unknown Primary Using Gene Expression Profiling with the 92-Gene Assay. (PubMed, Oncologist)
    Results suggest that molecular profiling with the 92-gene assay identifies a subset of ICI-eligible putative primary cancers in patients with CUP. We propose a treatment strategy based on available tests including clinicopathologic features, GEP, and ICI biomarkers of response.
    Journal • Clinical • IO biomarker
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    CancerTYPE ID®