Test Name

Solid Tumor Fusion Gene Panel

Test Number

LAB9064

CPT Codes

81456

Test Includes

The Solid Tumor Fusion Gene Panel is designed for identification of somatic known and novel gene fusions (or rarely pathogenic alternative transcripts due to gene rearrangements) in cancer patients. The test involves 145 clinical genes, which include kinases, transcriptional factors and others found to be recurrently altered in a variety of solid tumors. This panel evaluates 907 regions of interest within 145 clinical genes for the potential rearrangements.

Gene list in the panel:
ACVR2A, AKT1, AKT3, ALK, AR, ARAF, ARHGAP26, AXL, BCOR, BCORL1, BIRC3, BRAF, BRD3, BRD4, CAMTA1, CCNB3, CCND1, CIC, CSF1, CSF1R, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB3, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGFR4, FGR, FLT1, FLT3, FOS, FOSB, FOXO1, FOXO4, FUS, GLI1, GLIS2, GRB7, GRM1, HMGA2, IGF1R, INSR, JAK2, JAK3, JAZF1, KIT, KMT2A, MALT1, MAML2, MAST1, MAST2, MBTD1, MDM2, MEAF6, MET, MGEA5, MKL2, MN1, MSH2, MSMB, MUSK, MYB, MYBL1, MYC, NAB2, NCOA1, NCOA2, NCOA3, NFATC2, NFE2L2, NOTCH1, NOTCH2, NR4A3, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, NUTM2A, NUTM2B, PAX3, PAX5, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PGR, PHF1, PIK3CA, PKN1, PLAG1, PPARG, PRB3, PRKACA, PRKACB, PRKCA, PRKCB, PRKD1, PRKD2, PRKD3, PTCH1, PTPN1, RAD51B, RAF1, RELA, RET, RLF, ROS1, RSPO2, RSPO3, SRF, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, VGLL3, WWTR1, YAP1, YWHAE

Performing Laboratory / Facility

UCLA Molecular Diagnostics Laboratories (MDL)

Performing Section

Molecular Pathology

Availability

Monday through Friday, 0700-1700

Turnaround Time

14 days from receipt of required specimen in performing lab

Methodology

The Solid Tumor Fusion Panel uses Archer's AMP™ technology to interrogate specific regions of genes. This assay features a highly optimized oligonucleotide probe pool with specificity for the recurrent break points in the fusion partner genes that are recurrently rearranged in a variety of solid tumors. This panel evaluates 907 regions of interest within 145 clinical genes for the potential rearrangements. Sequencing of fusion libraries is performed on Illumina Miseq.

Use

The Solid Tumor Fusion Panel evaluates the gene fusion in cancer patients. The test involves 145 clinical genes, which include kinases, transcriptional factors and others found to be recurrently altered in a variety of solid tumors. The findings of this assay act in conjunction with clinical history and pathologic diagnoses for the clinical management of patients with different solid tumor malignancies.

Limitations

The panel should not be used for detecting residual fusions. This test cannot detect gene fusions outside the regions of interest (ROI) defined by the test. This assay is at risk of false negatives when tumor purity is low and/or RNA quality is suboptimal. Some fusions may not be detected due to local sequence characteristics or the presence of pseudogene.

Specimen Type

10 unstained formalin-fixed paraffin-embedded (FFPE) slides with ≥20% of neoplastic cells on the entire slide or in the circled tumor area. An H&E from the same tumor block is required.

Shipping and Handling Instructions

Transport specimen at room temperature.

Causes for Rejection

Incorrect tissue type, damaged slides, tissue quantity not sufficient
Test Information

Test Name

Solid Tumor Fusion Gene Panel

Test Number

LAB9064

CPT Codes

81456

Test Includes

The Solid Tumor Fusion Gene Panel is designed for identification of somatic known and novel gene fusions (or rarely pathogenic alternative transcripts due to gene rearrangements) in cancer patients. The test involves 145 clinical genes, which include kinases, transcriptional factors and others found to be recurrently altered in a variety of solid tumors. This panel evaluates 907 regions of interest within 145 clinical genes for the potential rearrangements.

Gene list in the panel:
ACVR2A, AKT1, AKT3, ALK, AR, ARAF, ARHGAP26, AXL, BCOR, BCORL1, BIRC3, BRAF, BRD3, BRD4, CAMTA1, CCNB3, CCND1, CIC, CSF1, CSF1R, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB3, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGFR4, FGR, FLT1, FLT3, FOS, FOSB, FOXO1, FOXO4, FUS, GLI1, GLIS2, GRB7, GRM1, HMGA2, IGF1R, INSR, JAK2, JAK3, JAZF1, KIT, KMT2A, MALT1, MAML2, MAST1, MAST2, MBTD1, MDM2, MEAF6, MET, MGEA5, MKL2, MN1, MSH2, MSMB, MUSK, MYB, MYBL1, MYC, NAB2, NCOA1, NCOA2, NCOA3, NFATC2, NFE2L2, NOTCH1, NOTCH2, NR4A3, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, NUTM2A, NUTM2B, PAX3, PAX5, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PGR, PHF1, PIK3CA, PKN1, PLAG1, PPARG, PRB3, PRKACA, PRKACB, PRKCA, PRKCB, PRKD1, PRKD2, PRKD3, PTCH1, PTPN1, RAD51B, RAF1, RELA, RET, RLF, ROS1, RSPO2, RSPO3, SRF, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFE3, TFEB, TFG, THADA, TMPRSS2, TTYH1, USP6, VGLL2, VGLL3, WWTR1, YAP1, YWHAE

Performing Laboratory / Facility

UCLA Molecular Diagnostics Laboratories (MDL)

Performing Section

Molecular Pathology

Availability

Monday through Friday, 0700-1700

Turnaround Time

14 days from receipt of required specimen in performing lab

Methodology

The Solid Tumor Fusion Panel uses Archer's AMP™ technology to interrogate specific regions of genes. This assay features a highly optimized oligonucleotide probe pool with specificity for the recurrent break points in the fusion partner genes that are recurrently rearranged in a variety of solid tumors. This panel evaluates 907 regions of interest within 145 clinical genes for the potential rearrangements. Sequencing of fusion libraries is performed on Illumina Miseq.

Use

The Solid Tumor Fusion Panel evaluates the gene fusion in cancer patients. The test involves 145 clinical genes, which include kinases, transcriptional factors and others found to be recurrently altered in a variety of solid tumors. The findings of this assay act in conjunction with clinical history and pathologic diagnoses for the clinical management of patients with different solid tumor malignancies.

Limitations

The panel should not be used for detecting residual fusions. This test cannot detect gene fusions outside the regions of interest (ROI) defined by the test. This assay is at risk of false negatives when tumor purity is low and/or RNA quality is suboptimal. Some fusions may not be detected due to local sequence characteristics or the presence of pseudogene.
Specimen Collection and Handling

Specimen Type

10 unstained formalin-fixed paraffin-embedded (FFPE) slides with ≥20% of neoplastic cells on the entire slide or in the circled tumor area. An H&E from the same tumor block is required.

Shipping and Handling Instructions

Transport specimen at room temperature.

Causes for Rejection

Incorrect tissue type, damaged slides, tissue quantity not sufficient
Result Interpretation