Clinical Genetic Test
offered by
GTR Test Accession: Help GTR000593389.1
Last updated in GTR: 2021-06-24
Last annual review date for the lab: 2022-06-17 Past due LinkOut
At a Glance
Therapeutic management
Solid tumor
ABL1 (9q34.12), ABL2 (1q25.2), ABRAXAS1 (4q21.23), ACVR1 (2q24.1), ACVR1B (12q13.13), ...
Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
OmniSeq INSIGHT is intended for use by qualified health care …
Not provided
Not provided
Ordering Information
Offered by: Help
Test short name: Help
Specimen Source: Help
Who can order: Help
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 525
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Total methods: 2
Method Category Help
Test method Help
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
IonTorrent S5XL
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NovaSeq 6000
Clinical Information
Test purpose: Help
Therapeutic management
Target population: Help
OmniSeq INSIGHT is intended for use by qualified health care professionals in accordance with professional guidelines in oncology for management of patients with solid neoplasms, and is not conclusive or prescriptive for labeled use of any specific therapeutic product.
Recommended fields not provided:
Technical Information
Test Platform:
Availability: Help
Tests performed
Interpretation performed in-house
Report generated in-house
Specimen preparation performed both in-house and at an outside lab
Wet lab work performed in-house

Test performance comments
PD-L1 technical component is performed at an outside lab. Some slide cutting and staining occurs at an outside lab
Analytical Validity: Help
Contact Laboratory for detailed Analytical validity documents. Precision: Repeatability and reproducibility of alterations associated with Tier I mutations and platform-wide alterations, including agreement for small variants, CNA, MSI, TMB, fusions and splice variants were evaluated. Repeatability (5 replicates intra-run under same conditions) and reproducibility of inter-run replicates (3-49 replicates under … View more
Assay limitations: Help
OmniSeq INSIGHT is not conclusive or prescriptive for use of any specific therapeutic product. OmniSeq INSIGHT has been validated using genomic DNA and RNA from formalin fixed paraffin-embedded tumor samples. OmniSeq INSIGHT is designed to report somatic variants and is not intended to report germline variants. Clinical validity performance of … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Not provided
NYS CLEP Approval: Help
Number: 80799
Status: Approved
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.