OmniSeq INSIGHT

CPT 81455; 88360(x2); 88381

Test Details

Cancer Type

Bladder, Brain, Breast, Cervical, Colorectal cancer (CRC), Endometrial, Gastroesophageal, Gastrointestinal stromal tumor (GIST), Glioblastoma, Head and neck, Lung, Melanoma, Non-small cell lung cancer, Ovarian, Prostate, Squamous cell carcinoma of the head and neck (SCCHN), Thyroid, Pan-cancer, Skin

Technology Used

NGS

Use

OmniSeq INSIGHTSM 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

OmniSeq assays are orderable through Integrated Oncology, a Labcorp Specialty Testing Group. For more information please visit the Integrated Oncology web site www.integratedoncology.com. Note: When submitting a sample, the pathology report, primary tumor type and state of disease are required.

Methodology

OmniSeq INSIGHTSM is a next generation sequencing-based in vitro diagnostic device; PD-L1 by immunohistochemistry

Specimen Requirements

Information on collection, storage, and volume

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides

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

Storage Instructions

FFPE blocks are stored at room temperature and shipped with no special precautions, except when daily outside temperatures exceed 38°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; 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.

Collection

Blocks and unstained slides (USS) must at a minimum be labeled with the pathology case number and block identification number.