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Type:
Laboratory Developed Test
1m
FGFR1 Mutations Are Rare Alternate Oncogenic Drivers in FOXL2-Wildtype Adult Granulosa Cell Tumors of the Ovary. (PubMed, Am J Surg Pathol)
These findings establish FGFR1 alterations as an alternative oncogenic driver in a subset of FOXL2-wildtype aGCTs. From a diagnostic standpoint, the absence of FOXL2 p.C134W mutation does not exclude the diagnosis of aGCT when the morphology and immunoprofile are characteristic.
Journal
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FGFR1 (Fibroblast growth factor receptor 1) • FOXL2 (Forkhead Box L2)
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MSK-IMPACT • OncoPanel™ Assay
2ms
Pentadecanoic Acid (C15:0) at Naturally Occurring Circulating Concentrations Has Selective Anticancer Activities Including Targeting B-Cell Lymphomas with CCND3 Oncogenic Alterations. (PubMed, Nutrients)
The potential use of C15:0 against cancers with CCND3 genetic alterations warrants further exploration. Further, there is a need to better understand the potential role of nutritional C15:0 deficiencies and CCND3 alterations on the observed rise in certain types of cancers, especially among young adults.
Journal
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CCND3 (Cyclin D3)
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OncoPanel™ Assay
2ms
Brief Report: Critical Role for DNA-Based Sequencing in Discriminating Distinct Primary Lung Cancers with Different MET Exon 14 Skipping Mutations. (PubMed, J Thorac Oncol)
DNA-based sequencing of the MET gene improves staging accuracy to guide appropriate management for patients with multiple primary METex14 mutant NSCLCs.
Journal
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MET (MET proto-oncogene, receptor tyrosine kinase)
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MET exon 14 mutation
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MSK-IMPACT • OncoPanel™ Assay
3ms
A Study of Abemaciclib in Recurrent Glioblastoma (clinicaltrials.gov)
P2, N=45, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jun 2025 --> Jun 2026
Trial completion date
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • CDK4 (Cyclin-dependent kinase 4) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • CDK6 (Cyclin-dependent kinase 6)
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CDKN2A deletion • IDH wild-type
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OncoPanel™ Assay
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Verzenio (abemaciclib)
3ms
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6 (clinicaltrials.gov)
P2, N=38, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Apr 2026 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Apr 2026
Trial completion date • Trial primary completion date
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CCND1 (Cyclin D1) • CDK4 (Cyclin-dependent kinase 4) • CDK6 (Cyclin-dependent kinase 6)
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OncoPanel™ Assay
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Verzenio (abemaciclib)
4ms
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Xiao X. Wei, MD | Trial primary completion date: Oct 2024 --> Jul 2025
Trial primary completion date
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PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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PD-L1 expression • MSI-H/dMMR
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OncoPanel™ Assay
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Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
4ms
Mutational signature analysis of chronic lymphocytic leukemia uncovering genomic patterns and prognostic implications. (PubMed, Am J Clin Pathol)
The de novo SBS signatures were identified as being associated with IGHV status, highlighting significant disease heterogeneity that belies the more categorical and limited traditional risk stratification methods. Also, a novel association was made between haloalkane exposure signature and CLL.
Journal
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OncoPanel™ Assay
4ms
High-Grade Early-Onset Prostate Cancer: Assessment of TMPRSS2::ERG-Negative Tumors Suggests Low Frequency of Germline Alterations and a Pathogenic Role for HOXB13. (PubMed, Am J Surg Pathol)
In conclusion, TMPRSS2::ERG fusion-negative HG-EOPC shows a high frequency of genomic alterations typically enriched in castration-resistant neoplasms but variants of potential germline origin (including those in mismatch repair genes) are rare. These results demonstrate that HG-EOPC is driven largely by somatic events.
Journal • BRCA Biomarker
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TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • PMS2 (PMS1 protein homolog 2) • ERG (ETS Transcription Factor ERG) • SPOP (Speckle Type BTB/POZ Protein) • TMPRSS2 (Transmembrane serine protease 2) • HOXB13 (Homeobox B13)
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OncoPanel™ Assay
4ms
Clinical Implementation of Matched Tumor/Germline Sequencing Improves Accuracy of Tumor Genomic Profiling and Therapeutic Recommendations. (PubMed, J Mol Diagn)
25% of validation cases (14% post-launch) had a pathogenic or likely pathogenic germline variant conferring cancer susceptibility; 14% of validation cases (7% post-launch) harbored a germline variant of therapeutic significance. Matched tumor/germline sequencing is more accurate than tumor-only sequencing, while still encompassing all genomic findings that inform targeted therapy selection.
Journal
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TMB (Tumor Mutational Burden)
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TMB-H • TMB-L
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OncoPanel™ Assay
5ms
A targeted next-generation sequencing panel for identification of clinically relevant mutation profiles in solid tumours. (PubMed, Sci Rep)
These findings demonstrate a sensitive, high throughput oncopanel that is suitable for use in routine clinical testing. The shorter turnaround time of the assay has the potential to significantly improve patient care by facilitating more timely and personalized clinical interventions.
Journal • Next-generation sequencing • BRCA Biomarker
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset)
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TP53 mutation • KRAS mutation • EGFR mutation • PIK3CA mutation
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OncoPanel™ Assay
5ms
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov)
P2, N=60, Active, not recruiting, Xiao X. Wei, MD | Trial completion date: Jun 2025 --> Dec 2025
Trial completion date
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PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDK12 (Cyclin dependent kinase 12) • CHEK2 (Checkpoint kinase 2) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • ABRAXAS1 (Abraxas 1 BRCA1 A Complex Subunit 2) • GEN1 (GEN1 Holliday junction 5' flap endonuclease)
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PD-L1 expression • MSI-H/dMMR
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OncoPanel™ Assay
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Opdivo (nivolumab) • docetaxel • goserelin acetate • Firmagon (degarelix) • leuprolide acetate for depot suspension
7ms
Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients (clinicaltrials.gov)
P=N/A, N=50, Active, not recruiting, National Health Research Institutes, Taiwan | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Dec 2025
Enrollment closed • Trial primary completion date
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KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha)
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OncoPanel™ Assay
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