12 - 14 days
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.
OmniSeq INSIGHT® is orderable through Labcorp Oncology. For more information please visit oncology.labcorp.com/cancer-care-team/test-menu/omniseq-insight. Note: When submitting a sample, the pathology report, primary tumor type and state of disease are required.
OmniSeq INSIGHT® is a next generation sequencing-based in vitro diagnostic device; PD-L1 by immunohistochemistry
For more information, please view the literature below.
Test Requisition Form - Gene Profiling Assays
Information on collection, storage, and volume
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides
Block is preferred, or send 20 unbaked, positively charged, unstained slides cut at 5µM plus 1 H&E.
20 unbaked, positively charged, unstained slides cut at 5µM
Paraffin block or slides
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.
Tumor block containing insufficient tumor tissue or no tumor; broken or stained slides; decalicified bone biopsies; cytology smears or samples from hematologic malignancies. Specimens with very small amounts of tumor and/or less than requested number of slides will be accepted with the caveat that complete testing may not be possible.
Blocks and unstained slides (USS) must at a minimum be labeled with the pathology case number and block identification number.
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