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COLONSEQPlus Panel
Test Code36919
CPT Codes
⁠⁠⁠⁠⁠⁠⁠81457<br><strong>This test is not available for New York patient testing.</strong>
Preferred Specimen
Paraffin-embedded Tissue accompanied by a circled H & E slide indicating the area to be examined submitted in sterile biohazard plastic bag
Other Acceptable Specimens
15 formalin-fixed paraffin-embedded tissue slides and H & E slide (or 1 additional slide) submitted in slide holder
Instructions
Specimen to be tested must contain a minimum of 10% tumor
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Refrigerated: Indefinitely
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Next Generation Sequencing • Polymerase Chain Reaction (PCR) • MSI
FDA Status
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.
Setup Schedule
Tuesday Morning
Report available: 8 Days
Report available: 8 Days
Reference Range
See Laboratory Report
Clinical Significance
This test is intended to be used as a disease specific solid tumor panel to aid the oncologist in prioritizing standard of care therapy choices for their patients with Colorectal Cancer.
