OmniSeq INSIGHTSM

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Updated on 06/1/2022
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Special Instructions

OmniSeq INSIGHTSM 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 INSIGHTSM 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 INSIGHTSM 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 INSIGHTSM 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 INSIGHTSM 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.



Specimen Requirements


Specimen

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

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

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

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

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.

Block is preferred, or send 20 unbaked, positively charged, unstained slides cut at 5µM plus 1 H&E.

Block is preferred, or send 20 unbaked, positively charged, unstained slides cut at 5µM plus 1 H&E.

Block is preferred, or send 20 unbaked, positively charged, unstained slides cut at 5µM plus 1 H&E.

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

Paraffin block or slides

Paraffin block or slides

Paraffin block or slides

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.

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

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

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

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 38°C, and then ship with cool packs to avoid paraffin meltdown.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.


Methodology

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

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

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

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

OmniSeq INSIGHTSM 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(SM) LCA Client 831073 Microdissection Pending
831177 OmniSeq INSIGHT(SM) LCA Client 831074 Result: Pending
831177 OmniSeq INSIGHT(SM) LCA Client 831078 PD-L1 IHC Marker(Professional) Pending
831177 OmniSeq INSIGHT(SM) LCA Client 831079 PD-L1 IHC Marker(Prof)Additl Pending
831177 OmniSeq INSIGHT(SM) LCA Client 831178 Billing Hold Pending
831177 OmniSeq INSIGHT(SM) LCA Client 831080 PDF Not Available

How to Order

Oncology Speciality Testing

Test Requisition Form Ordering Instructions

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CPT Statement/Profile Statement

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