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Specimen Collection Manual and Test Catalog

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MYGENVAR FUSION GENE PANEL, NEXT GENERATION SEQUENCING

Geisinger Epic Procedure Code:  LAB5039    Geisinger Epic ID:  190554
Test Restriction:  LAB ORDER ONLY

SPECIMEN COLLECTION
Specimen type:  Formalin-fixed, paraffin-embedded tissue (FFPE) OR fresh tissue (including bone marrow aspirate)
Preferred collection container: 
Specimen required: 
FFPE tissue: Six (6) unstained slides (USS), 10 µm thickness each, in slide folder (protected from light)
Bone Marrow: 3 mL lavender-top K2 EDTA tube (part of Bone Marrow Panel Collection – Bone Marrow Aspirate – Two [2] K2 EDTA Tube[s])
Fresh tissue: Place in liquid medium (e.g., RPMI)
Special notes: 
FFPE tissue: For non-Geisinger sites, send six (6) unstained slides, 10 µm thickness, H&E slide, source of specimen and tumor assessment. Alternatively, send the FFPE block and additional information.
Bone marrow: For non-Geisinger sites, collection tube is included in the bone marrow (BM) collection kit.
NOTE: Isolated/extracted nucleic acids are acceptable only from CLIA-certified laboratories or a laboratory meeting equivalent requirements as determined by CAP and/or CMS.

SPECIMEN PROCESSING
Processing instructions: 
Mix well immediately. Do not centrifuge or separate plasma from cells.
Transport temperature: 
FFPE tissue:  Room temperature (18-25°C).
Bone marrow/fresh tissue: Refrigerated (2-8°C)
Specimen stability: 
FFPE Tissue: Room temperature (18-25°C), indefinitely
Bone marrow/fresh tissue: Refrigerated (2-8°C), 3 days. Specimen must be extracted within 3 days.
Rejection criteria: 
FFPE blocks containing no tumor (evaluated by pathologist). FFPE tissues that have been decalcified. Insufficient DNA and/or RNA. Wrong collection tube. Improper storage or transport temperature. Stability limits exceeded. Shared or comingled specimens.

TEST DETAILS
Reference interval: 
Negative (no mutations detected)
CPT code(s):  81456
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 
This assay is based on the next-generation sequencing (NGS) of RNA (cDNA) and is a multigene panel which detects somatic oncogenic gene fusions and exon skipping. Genes included in the assay are ACVR2A, AKT1, AKT2, AKT3, ALK, AR, ARHGAP26, ARHGAP6, ARID1A, ATF1, AXL, BCOR, BCORL1, BRAF, BRD3, BRD4, CAMTA1, CCNB3, CCND1, CD274, CIC, CREB3L1, CREB3L2, CRTC1, CRTC3, CSF1, CSF1R, CTNNB1, DDIT3, DDX3X, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGF1, FGFR1, FGFR2, FGFR3, FGFR4, FGR, FLI1, FLT1, FLT3, FOS, FOSB, FOXO1, FOXO4, FOXR2, FUS, GLI1, GNA14, GNAQ, GRB7, GRM1, HMGA2, HRAS, IDH1, IDH2, IGF1R, INSR, JAK2, JAK3, JAZF1, KIT, KRAS, MAML1, MAML2, MAP2K1, MAST1, MAST2, MBTD1, MDM2, MEAF6, MERTK, MET, MGEA5, MKL2, MN1, MSMB, MUSK, MYB, MYBL1, MYC, MYH9, MYOD1, NCOA1, NCOA2, NCOA3, NCOA4, NFATC2, NFE2L2, NFIB, NOTCH1, NOTCH2, NOTCH3, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, NUTM2A, PATZ1, PAX3, PAX5, PAX7, PAX8, PDGFB, PDGFD, PDGFRA, PDGFRB, PGR, PHF1, PHKB, PIK3CA, PKN1, PLAG1, PPARG, PRB3, PRDM10, PRKACA, PRKACB, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, PTCH1, PTPN1, RAD51B, RAF1, RELA, RET, RLF, ROS1, RSPO2, RSPO3, SERPINE1, SMAD3, SMARCA2, SMARCA4, SRF, SS18, SS18L1, STAT6, TAF15, TCF12, TEK, TERT, TFE3, TFEB, TFG, TGFA, TGFBR3, THADA, TMPRSS2, USP6, VGLL2, VGLL3, WWTR1, YAP1, YWHAE.
Methodology: 
Next Generation Sequencing
RNA extraction
Synonyms: 
Next Generation Sequencing, RNA Fusion, Sarcoma, Solid Tumor Gene Panel, FUSGP
Clinical significance: 
The MyGenVar Pan Fusion Gene Panel targets RNA fusions and exon skipping by high-throughput sequencing. It helps determine diagnostic classification and provide prognostic or therapeutic information for clinical management.
Doctoral Director(s): 
Yi Ding MD, PhD
Review Date:  09/24/2024

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