TruSight Oncology Comprehensive IVD
Expected Turnaround Time
21 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
TruSight Oncology Comprehensive IVD is a comprehensive genomic profiling assay based on NGS variant detection in FFPE tissue. Sequencing is performed using Illumina’s NextSeq 550Dx. This IVD assay currently has companion diagnostic (CDx) claims for NTRK and RET fusions. In addition, single-, multi-nucleotide variants, insertions and deletions in 517 genes with mutation frequencies = 5%, fusions in 24 genes, RNA splice variants in EGFR and tumor mutational burden (TMB) scores are reported.
Requisition Forms
Specimen Requirements
Specimen Requirements
- Formalin-fixed, paraffin-embedded (FFPE) tissue block, 10% NBF fixed
- FFPE tissue with a minimum of 20% tumor content and a tissue volume ≥ 1.0 mm3
- Macrodissection may be possible if < 20% tumor burden is observed.
- FFPE slides: 5 slides minimum, 10% NBF fixed.
- This volume is equivalent to a cumulative viable tissue area of ≥ 200 mm2 using 5μm thick sections, or ≥ 100 mm2 using 10 μm thick sections.
- Necrotic tissue (≥ 25%) can interfere with the ability of the assay to detect RNA fusions.
Specimen Stability
Indefinite at ambient temperature
Storage Requirements
Ambient temperature
Shipping Conditions
Ambient
Shipping Recommendations
AMBIENT. Use a refrigerated (not frozen) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
Specimen Rejection Criteria
Improper specimen labeling; insufficient tissue; insufficient tumor burden; >25% necrotic regions; insufficient RNA or DNA isolated.
Test Details
Keywords
Solid tumor, NGS, comprehensive genomic profiling, IVD, FDA-approved
Test Method
Next Generation Sequencing (NGS)
Methodology Category
Molecular
Regulatory Status
FDA-Approved Companion Diagnostic (CDx), IVD
Special Considerations
- For biopharma and clinical trial use, previously extracted and purified DNA and/or RNA performed in a CAP/CLIA-accredited laboratory is acceptable. It is the responsibility of the client to ensure that the initial specimen met the tumor content specimen requirements.
- DNA stored at -25 to -15 oC has indefinite stability. RNA stored at -85°C to -65°C has indefinite stability.
Associations
This test code should be ordered in conjunction with M NGS CGP.
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