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Type:
Laboratory Developed Test
1d
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 | Trial primary completion date: Dec 2025 --> Dec 2029
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
10d
Integrative Clinical and Molecular Evaluation of Renal Cell Carcinoma with Merlin Protein Deficiency and Biallelic Loss of NF2. (PubMed, Clin Cancer Res)
Biallelic NF2 inactivation and merlin protein deficiency drives an aggressive RCC phenotype marked by immune dysfunction, high proliferation, and frequent cell cycle and DNA damage-response signaling alterations. Limited treatment response to immunotherapy highlights the need for molecularly tailored therapies.
Journal • IO biomarker
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • NF2 (Neurofibromin 2)
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CDKN2A deletion
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OncoPanel™ Assay
1m
A new algorithm Precision OncoPanels (PrOPs) identifies short individualized actionable panels that can guide cancer treatment: a pan-cancer analysis of TCGA cohorts. (PubMed, NAR Genom Bioinform)
Among the clinical cohorts, PrOPs identified clinically relevant actionable panels in 93% of patient cases. The extensive testing of our algorithm and demonstrated generalizability in six different cancers indicate the usefulness of our algorithm in precision oncology.
Journal • BRCA Biomarker • Pan tumor
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BRCA (Breast cancer early onset)
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OncoPanel™ Assay
3ms
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
3ms
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
4ms
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
5ms
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)
5ms
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)
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 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
5ms
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
6ms
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
6ms
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
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