Test Details
Methodology
OmniSeq® INSIGHT is a next generation sequencing-based in vitro diagnostic device; PD-L1 by immunohistochemistry
Result 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.
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
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.
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 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; 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.
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 831177 | OmniSeq INSIGHT(R) LCA Client | 831073 | Microdissection | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 831074 | Result: | 48014-5 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833801 | Microsatellite Instability | 81695-9 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833803 | Immune Gene Expression RNA Seq | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833833 | Single Nucleotide Variants | 81289-1 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833800 | Tumor Mutational Burden | mut/Mb | 94077-5 | |
| 831177 | OmniSeq INSIGHT(R) LCA Client | 831078 | PD-L1 IHC Marker(Professional) | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 831079 | PD-L1 IHC Marker(Prof)Additl | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833802 | PD-L1 IHC 22C3 (prof) | 83054-7 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833552 | PD-L1 IHC Marker Technical | Pending | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833828 | PD-L1 IHC 22C3 TPS (prof) | 83054-7 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833829 | PD-L1 IHC SP142 (prof) | 85149-3 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833834 | PD-L1 IHC 22C3 TPS (tech) | 85147-7 | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833835 | PD-L1 IHC 22C3 CPS (tech) | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833836 | PD-L1 IHC SP142 (tech) | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 831178 | Billing Hold | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833837 | TMB billing | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833838 | MSI billing | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833839 | PD-L1 billing | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 833840 | RNA billing | N/A | ||
| 831177 | OmniSeq INSIGHT(R) LCA Client | 831080 | 11502-2 | |||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 831073 | |||||
| Result Code Name | Microdissection | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 831074 | |||||
| Result Code Name | Result: | |||||
| UofM | ||||||
| Result LOINC | 48014-5 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833801 | |||||
| Result Code Name | Microsatellite Instability | |||||
| UofM | ||||||
| Result LOINC | 81695-9 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833803 | |||||
| Result Code Name | Immune Gene Expression RNA Seq | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833833 | |||||
| Result Code Name | Single Nucleotide Variants | |||||
| UofM | ||||||
| Result LOINC | 81289-1 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833800 | |||||
| Result Code Name | Tumor Mutational Burden | |||||
| UofM | mut/Mb | |||||
| Result LOINC | 94077-5 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 831078 | |||||
| Result Code Name | PD-L1 IHC Marker(Professional) | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 831079 | |||||
| Result Code Name | PD-L1 IHC Marker(Prof)Additl | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833802 | |||||
| Result Code Name | PD-L1 IHC 22C3 (prof) | |||||
| UofM | ||||||
| Result LOINC | 83054-7 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833552 | |||||
| Result Code Name | PD-L1 IHC Marker Technical | |||||
| UofM | ||||||
| Result LOINC | Pending | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833828 | |||||
| Result Code Name | PD-L1 IHC 22C3 TPS (prof) | |||||
| UofM | ||||||
| Result LOINC | 83054-7 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833829 | |||||
| Result Code Name | PD-L1 IHC SP142 (prof) | |||||
| UofM | ||||||
| Result LOINC | 85149-3 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833834 | |||||
| Result Code Name | PD-L1 IHC 22C3 TPS (tech) | |||||
| UofM | ||||||
| Result LOINC | 85147-7 | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833835 | |||||
| Result Code Name | PD-L1 IHC 22C3 CPS (tech) | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833836 | |||||
| Result Code Name | PD-L1 IHC SP142 (tech) | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 831178 | |||||
| Result Code Name | Billing Hold | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833837 | |||||
| Result Code Name | TMB billing | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833838 | |||||
| Result Code Name | MSI billing | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833839 | |||||
| Result Code Name | PD-L1 billing | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 833840 | |||||
| Result Code Name | RNA billing | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||
| Order Code | 831177 | |||||
| Order Code Name | OmniSeq INSIGHT(R) LCA Client | |||||
| Order Loinc | ||||||
| Result Code | 831080 | |||||
| Result Code Name | ||||||
| UofM | ||||||
| Result LOINC | 11502-2 |