Next Generation Sequencing Fusion Profile Assay


Sunquest Code:RNAFUS  
Epic Code:LAB8096Epic Name:NGS Fusion Profile Assay
Sunquest Code (non-Epic sites):RNAFUS  
Synonyms:NGS Fusion Profile; ALK; ROS1; NTRK1; NTRK3; RET; MET
Methodology:Next generation sequencing
Test Includes:ALK, ROS1, NTRK1, NTRK3, RET, MET
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 Molecular Diagnostics  (UMMC-East Bank)


Interpretive

Reference Range:See interpretive report.
Use:The NGS Fusion Profile Assay can detect rearrangements in the genes ALK, NTRK1, NTRK3, RET and ROS1, as well as exon 14 skipping alterations in the MET gene. These genes are well-characterized driver oncogenes which can be  mutated or rearranged in a variety of cancers. Patients with tumors carrying these genomic abnormalities in ALK, NTRK1, NTRK3, RET, ROS1 and MET are predicted to respond to FDA-approved tyrosine kinase inhibitors specific to these chimeric protein products.

This assay detects gene fusions seen in lung cancer, infantile fibrosarcoma and other solid tumors to identify actionable rearrangements that guide targeted therapy selection and/or inform diagnostic classification. Please note that this assay does not detect NTRK2 alterations.


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