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Comprehensive ColonSEQPlus: 1016997
MessagePlease provide most recent Pathology report.
Test Code
MDFCPCOLONSEQP or 1016997
CPT Codes
81457, 88360
Includes
Includes the following biomarkers:
APC, BRAF, CTNNB1, EGFR, ERBB2, FBXW7, KRAS, MET, NRAS, PIK3CA, PTEN, SMAD4, TP53, MSI, and HER2 by IHC*
*HER2 by IHC will reflex to FISH if equivocal
APC, BRAF, CTNNB1, EGFR, ERBB2, FBXW7, KRAS, MET, NRAS, PIK3CA, PTEN, SMAD4, TP53, MSI, and HER2 by IHC*
*HER2 by IHC will reflex to FISH if equivocal
Instructions
Tissue.
Transport Container
Paraffin embedded tissue block accompanied by a circled H & E slide indicating the area to be examined: submit in sterile biohazard plastic bag. Slides: submit 15 FFPE slides and 1 H & E slide (or one additional slide) in slide holder. Specimen to be tested must contain a minimum of 10 percent tumor.
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
Next Generation Sequencing (NGS)
Setup Schedule
Tuesday
Report Available
8-10 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
(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
Reference Range
An interpretive report will be provided.
Clinical Significance
The Comprehensive ColonSEQPlus panel is intended to be used for the detection of somatic alterations within clinically relevant genes in order to help predict response to targeted therapies and prioritize treatment for patients with colorectal cancer. All results should be interpreted in conjunction with other clinical and pathological findings.
Performing Laboratory
med fusion
