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FusionSEQ Panel
Test Code12353
CPT Codes
81449<br>** This test is not available for New York patient testing **
Includes
FusionSEQ
ALK RNA Rearrangement
EGFR RNA Rearrangement
FGFR1 RNA Rearrangement
FGFR2 RNA Rearrangement
FGFR3 RNA Rearrangement
MET RNA Rearrangement
NRG1 RNA Rearrangement
NTRK1 RNA Rearrangement
NTRK2 RNA Rearrangement
NTRK3 RNA Rearrangement
RET RNA Rearrangement
ROS1 RNA Rearrangement
EGFR Skipping
MET Skipping
ALK RNA Rearrangement
EGFR RNA Rearrangement
FGFR1 RNA Rearrangement
FGFR2 RNA Rearrangement
FGFR3 RNA Rearrangement
MET RNA Rearrangement
NRG1 RNA Rearrangement
NTRK1 RNA Rearrangement
NTRK2 RNA Rearrangement
NTRK3 RNA Rearrangement
RET RNA Rearrangement
ROS1 RNA Rearrangement
EGFR Skipping
MET Skipping
Preferred Specimen
6-10 slides (10-micron sections) for resection or surgical specimens or
10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder
10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder
Minimum Volume
6 slides
10 slides (core needle biopsy)
10 slides (core needle biopsy)
Other Acceptable Specimens
Tissue collected in a paraffin-embedded tissue block accompanied by a circled H&E slide
Instructions
Preferred: Slides
Submit 6-10 slides (10 micron sections) for resection or surgical specimens or 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder at ambient temperature.
Acceptable: Tissue transport container
Submit paraffin embedded tissue block accompanied by a circled H&E slide indicating the area to be examined:
submit in sterile biohazard plastic bag at ambient temperature or on ice pack in summer.
Do not freeze. Do not reject.
Specimen to be tested should contain a minimum of 10 percent tumor nuclei. Decalcified specimens are not acceptable. All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.
Submit 6-10 slides (10 micron sections) for resection or surgical specimens or 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder at ambient temperature.
Acceptable: Tissue transport container
Submit paraffin embedded tissue block accompanied by a circled H&E slide indicating the area to be examined:
submit in sterile biohazard plastic bag at ambient temperature or on ice pack in summer.
Do not freeze. Do not reject.
Specimen to be tested should contain a minimum of 10 percent tumor nuclei. Decalcified specimens are not acceptable. All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Refrigerated: Acceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Anchored Multiplex Polymerase Chain Reaction • Next Generation Sequencing
Setup Schedule
Sets up 7 days a week.
Clinical Significance
The FusionSEQ assay detects the presence of known and novel gene rearrangements (fusions) and exon skipping events in clinically relevant genes associated with the pathogenesis of many pediatric and adult solid tumors malignancies. FDA approved therapies and clinical trials are available for patients with these genomic abnormalities in certain solid tumors, and the detection of these abnormalities is beneficial in the management of disease and survival of the patient.