| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
FusionSEQ : 1016974
Test CodeMDFCPFSEQ or 1016974
CPT Codes
81449
Includes
The FusionSEQ assay is designed to detect the presence of gene rearrangements (fusions) and exon skipping events in clinically relevant genes associated with the pathogenesis of many pediatric and adult solid tumor malignancies. The test can detect known and novel gene rearrangements (fusions) in NTRK1, NTRK2, NTRK3, FGFR1, FGFR2, FGFR3, ALK, ROS1, RET, EGFR, and NRG1, and exon 14 skipping events in MET and exon 2-7 skipping events in EGFR.
If you have any further questions, additional needs, or would like to speak with med fusion’s scientific staff, pathologists, or client services, please contact us at 972-966-7050/844-966-7050.
If you have any further questions, additional needs, or would like to speak with med fusion’s scientific staff, pathologists, or client services, please contact us at 972-966-7050/844-966-7050.
Instructions
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.
Slides: submit 6-10 slides (10-micron sections) for resection or surgical specimens and 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder at ambient temperature.
Specimen to be tested should contain a minimum of 10 percent tumor nuclei. Decalcified specimens are not acceptable.
Slides: submit 6-10 slides (10-micron sections) for resection or surgical specimens and 10-20 slides (10-micron sections) for core needle biopsies with H&E slide in slide holder at ambient temperature.
Specimen to be tested should contain a minimum of 10 percent tumor nuclei. Decalcified specimens are not acceptable.
Transport Temperature
Paraffin embedded Tissue: Ambient or on ice pack in summer; Slides: Ambient.
Specimen Stability
Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen.
Methodology
Anchored Multiplex PCR (AMP™), Next Generation Sequencing
Setup Schedule
Sunday - Saturday
Report Available
10-12 days
Limitations
Laboratory test results should always be considered in the context of clinical observations. This test was developed and its performance characteristics determined by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Reference Range
An interpretive report will be provided.
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 tumor 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.
Performing Laboratory
med fusion
