OmniSeq® INSIGHT
Use
OmniSeq® INSIGHT is a next generation sequencing-based in vitro diagnostic device for the detection of genomic variants, signatures, and immune gene expression in formulin-fixed paraffin-embedded (FFPE) tumor tissue. DNA is sequenced to detect small variants; single and multi-nucleotide substitutions, insertions, deletions and indels, and copy number alterations (CNA) gains and losses in 523 genes, including 14 genes leading to homologous recombination repair defects (HRR/HRD), as well as analysis of microsatellite instability (MSI) and tumor mutational burden (TMB) signatures. RNA is also sequenced for detection of fusions and splice site variants in 55 genes in addition to mRNA expression in 64 immune genes. The resultant information, along with PD-L1 protein expression by immunohistochemistry (IHC), is intended for use by qualified health care professionals in accordance with practice guidelines and standards in oncology for patients with solid neoplasms.
Special Instructions
Not provided.
Limitations
This test may not detect all variants in the targeted regions of interest. Accuracy is subject to limits of detection inherent in the testing methodology. Test results should be interpreted in context with other clinical findings. Specimens with insufficient tumor tissue or less than the requested number of slides may lead to incomplete testing and analysis.
Methodology
NGS (Targeted)
Biomarkers
LOINC Codes
- 8100-0 - Specimen preparation
- 48014-5 - Sequence Variation Panel Bld/T
- 81695-9 - MSI Ca spec-Imp
- 8267-7 - Service Cmnt 06-Imp
- 81289-1 - Struct var type
- 94077-5 - TMB Tumor-Imp
- 8251-1 - Service Cmnt-Imp
- 8262-8 - Service Cmnt 02-Imp
- 83054-7 - PD-L1 by 22C3 Tiss ImStn-Imp
- 8266-9 - Service Cmnt 05-Imp
- 85149-3 - PD-L1 by SP142 Tiss ImStn Doc
- 85147-7 - PD-L1 by 22C3 Tiss ImStn Doc
- 8268-5 - Service Cmnt 07-Imp
- 8269-3 - Service Cmnt 08-Imp
- 8270-1 - Service Cmnt 09-Imp
- 8252-9 - Service Cmnt 10-Imp
- 8253-7 - Service Cmnt 11-Imp
- 8254-5 - Service Cmnt 12-Imp
- 8255-2 - Service Cmnt 13-Imp
- 8256-0 - Service Cmnt 14-Imp
- 8257-8 - Service Cmnt 15-Imp
- 11502-2 - Laboratory report
Result Turnaround Time
10-12 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Block is preferred, or send 20 unbaked, positively charged, unstained slides cut at 5µM plus 1 H&E.
Minimum Volume
20 unbaked, positively charged, unstained slides cut at 5µM
Container
Paraffin block or slides
Collection Instructions
Blocks and unstained slides (USS) must at a minimum be labeled with the pathology case number and block identification number.
Storage Instructions
FFPE blocks are stored at room temperature and shipped with no special precautions, except when daily outside temperatures exceed 35°C, and then ship with cool packs to avoid paraffin meltdown.
Causes for Rejection
Tumor block containing insufficient tumor tissue or no tumor; broken or stained slides; decalcified bone biopsies; cytology smears or samples from hematologic malignancies.
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