Next Generation Sequencing Fusion Profile Assay


Abbrev Code:RNAFUS   
Order Code:LAB8096Order Name:NGS Fusion Profile Assay
Synonyms:NGS Fusion Profile; ALK; ROS1; NTRK1; NTRK3; RET; MET
Methodology:Next generation sequencing
CPT Codes: 81445 x1, G0452 x1, 81445 x1, G0452 x1
Test Includes:AKT1, AKT3, ALK, AR, ARHGAP26, AXL, BCOR, BRAF, BRD3, BRD4, CAMTA1, CCNB3, CCND1, CD274, CIC, CSF1, CSF1R, CTNNB1, DNAJB1, ERBB4, EGFR, EPC1, ERBB2, ERG, ESR1, ESRRA, ETV1, ETV4, ETV5, ETV6, EWSR1, FGFR1, FGFR2, FGFR3, FGR, FOS, FOSB, FOXO1, FOXO4, GRB7, FOXR2, FUS, GLI1, HMGA2, HRAS, IDH1, IDH2, INSR, JAK2, JAK3, JAZF1, KRAS, MAML2, MAP2K1, MAST1, MAST2, MEAF6, MET, MUSK, MYB, MLK2, MN1, MSMB, MYBL1, MYOD1, NCOA1, NCOA2, NOTCH1, NOTCH2, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUMBL, NUTM1, PAX3, PHF1, PIK3CA, PDGFB, PDGFRA, PDGFRB, PKN1, PLAG1, PPARG, PRKACA, PRKCA, PRKCB, RAF1, RELA, RET, ROS1, RSPO2, RSPO3, SS18, STAT6, TFE3, TFEB, TFG, TAF15, TCF12, TERT, THADA, TMPRSS2, USP6, VGLL2, YAP1, YWHAE
Turnaround Time:Performed Mon-Fri; results are reported within 10-14 days.
Special Instructions:Fixed samples: Include block number for testing.


Collection Instructions

Specimen:Fresh tissue slides; fresh tissue
Optimal Volume:5 unstained slides (10 microns thick) and 1 H&E slide (10 microns thick) fixed tissue
Minimum\Peds Volume:5 unstained slides (10 microns thick) and 1 H&E slide (10 microns thick) fixed tissue
Container:Plastic leakproof container, sterile
Causes for Rejection:Tissue: decalcified tissue, fixatives other than formalin used.  Samples containing less than 10% tumor will not be tested.


Processing and Shipping

Specimen Processing:Do not process. Store at room temperature.
Shipping Instructions:Ship at room temperature. Do not refrigerate or freeze.
Stability:Do not refrigerate or freeze.
Test Performed at or Referral Lab UM Molecular Diagnostics (M)  (UMMC East Bank)


Interpretive

Reference Range:See interpretive report.
Use:The NGS Oncology (NGSO) Pan Tumor Fusion assay is an RNA-based Next Generation Sequencing assay validated for the detection of a wide spectrum of oncogenic fusions in solid tumors and sarcomas which predict therapeutic response or provide diagnostic information on tumor type. The assay comprehensively targets 109 genes and utilizes anchored multiplex PCR (AMP) chemistry to enable detection of known and unknown fusion partners with the listed genes.

This assay is intended to detect fusions involving NTRK 1/2/3, ALK, ROS, RET, FGFR1/2/3, which have approved targeted therapies as well as other fusions which may provide eligibility for clincal trials. The assay is also intended to detect diagnostic fusions in numerous clinical contexts including: soft tissue sarcomas, CNS malignancies, and head and neck malignancies.


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