OmniSeq® INSIGHT

TEST: 831177
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CPT: 81459; 88360(x2); 88381
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Special Instructions

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.

Expected Turnaround Time

12 - 14 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

For more information, please view the literature below.

Test Requisition Form - Gene Profiling Assays

OmniSeq® INSIGHT Gene List

OmniSeq® INSIGHT Brochure

Sample Report – Lung

    Specimen Requirements

    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

    Collection

    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; 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.

    Test Details

    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.

    Methodology

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

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    831177 OmniSeq INSIGHT(R) LCA Client 74661-0 831073 Microdissection N/A
    831177 OmniSeq INSIGHT(R) LCA Client 74661-0 831074 Result: 48014-5
    831177 OmniSeq INSIGHT(R) LCA Client 74661-0 831078 PD-L1 IHC Marker(Professional) N/A
    831177 OmniSeq INSIGHT(R) LCA Client 74661-0 831079 PD-L1 IHC Marker(Prof)Additl N/A
    831177 OmniSeq INSIGHT(R) LCA Client 74661-0 831178 Billing Hold N/A
    831177 OmniSeq INSIGHT(R) LCA Client 74661-0 831080 PDF Not Available

    How to Order

    Oncology Speciality Testing

    Test Requisition Form Ordering Instructions

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    CPT Statement/Profile Statement

    The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf