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COMPREHENSIVE SOLID TUMOR PANEL NGS
Test CodeLAB662
CPT Codes
0250U and 88387
Includes
Detailed interpretation of the genetic findings will be included in the report. This FDA-cleared assay only detects variants within genes (exons) interrogated in this panel, which includes 505 genes along with TMB, MSI, translocation in ALK, NTRK2, NTRK3 and RET genes and amplifications in ERBB2. This test is NOT appropriate for MRD monitoring.
Preferred Specimen
1 HE slide + 10 formalin-fixed, paraffin-embedded (FFPE) unbaked slides of 5-micron thickness.
Note: Please make sure the orientation of circled section on HE slide matches with the other 10 FFPE unbaked, 5-micron slides.
Must be > or = 20% tumor
Note: Please make sure the orientation of circled section on HE slide matches with the other 10 FFPE unbaked, 5-micron slides.
Must be > or = 20% tumor
Minimum Volume
Concentration of 1 ng/uL of DNA
Other Acceptable Specimens
100 ng DNA from tumor tissue having at least > or = 20% tumor content.
Transport Temperature
FFPE slides: room temperature
Extracted DNA: ship at -20°C
Extracted DNA: ship at -20°C
Specimen Stability
Slides: indefinitely
Extracted DNA: 3 months at -20°C
Extracted DNA: 3 months at -20°C
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
-Non-validated sample type
-Specimen container not labeled properly with patient name, birth date, and hospital or sample ID number.
-If the tissue block has <20% tumor content
-If the DNA extracted from non-CLIA laboratory and has suboptimal amount.
-Broken specimen container
-Specimen container not labeled properly with patient name, birth date, and hospital or sample ID number.
-If the tissue block has <20% tumor content
-If the DNA extracted from non-CLIA laboratory and has suboptimal amount.
-Broken specimen container
Methodology
Next Generation Sequencing (NGS)
Setup Schedule
Weekly (Sample should be received by Friday: 12:30pm to be included in the next run.
Turn around time: 21 days
Turn around time: 21 days
Reference Range
No Clinically reportable variant detected
Performing Laboratory
West Virginia University Hospitals Inc.
WVUH - Molecular Diagnostics Laboratory-3040 University Ave, Suite 1300; Morgantown, WV 26505
