Intended Use
The assay is intended for detection of hundreds of variants across 161 genes relevant to solid tumors including hotspots, single nucleotide variants (SNVs), insertions and deletions (INDELs), copy number variants (CNVs), and gene fusions, in a single workflow.
Specimen Required
FFPE tumor tissue
Patient Preparation
- Sample Collection: FFPE tumor tissue
- Specimen Preparation: Formalin fix (10 percent neutral buffered formalin) and paraffin embedded tissue. Protect from excessive heat. Tissue block will be returned after testing. Transport tissue block or 5 unstained 5-micron slides.
- Storage/Transport Temperature: Room temperature. Ship in cooled container during summer months.
- Unacceptable Conditions
- Less than 25 percent tumor.
- Specimens fixed in any fixative other than 10 percent neutral buffered formalin.
- Bone specimens submitted in non-EDTA decalcifier.
- Remarks: Include surgical pathology report. If multiple specimens are sent to CMDL without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
- Stability: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Massively Parallel Sequencing: The Comprehensive Assay v3 uses next-generation sequencing (NGS) to analyse 161 key cancer genes using small amounts of DNA or RNA from common tissue samples (FFPE).
Sample Received to Report Turnaround Time (TAT)
Twice in a week (Scheduled Test)
Reference Interval
–
Interpretive Data
Refer to report.
Resources
- Additional Technical Information
- Test Request Form
Sample Reports
- Enhanced Report
- See report